HYPERTENSION 1

Evidence Based Practice To Reduce Blood Pressure in African American Males

Pierre Nkurunziza RN BSN

Neeta Monteiro RN BSN

David Buchanan RN BSN

Sarah Fisher RN BSN

Wright State University-Miami Valley College of Nursing and Health

NUR 788 ndash Spring 2012

HYPERTENSION 2

Table of Contents

Cover pagehelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip1

Abstracthelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip3

Problem Statement helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip4-

6

Planning the Practice Change Team helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip6-8

Critical Appraisal of Evidence helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip8-

10

Plan a Pilot Test of the Change helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip10-15

Evaluation helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip15-18

Human Subjects Concerns helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip18-

19

Budget helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

19

Conclusionhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip19-20

References helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip21-23

Appendiceshelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip24-29

Appendix A helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip24

Appendix B helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip25

Appendix C hellip (refer to a separate document)helliphelliphelliphelliphelliphellip25

Appendix D helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip26

Appendix E helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip27

Appendix Fhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip28

Appendix G helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip29

Abstract

According to the Centers for Disease Control and Prevention (2012) African Americans

[AA] (444) have the highest prevalence of hypertension (HTN) when compared to Whites

(326) and Mexican Americans (283) The research team proposed a culturally-sensitive

educational intervention via tele-monitoring delivered by Advance Practice Nurses (APNs) in a

private family practice setting The goal is to reduce blood pressure (BP) readings in AA males

aged gt 40 years to within normal range of lt 12080 mmHg over a six-month period Stakeholders

include patients family members physician APNs and private practice staff Resistance may

come from staff and APNs because of additional work responsibilities in managing patients

Strengths of change include decreasing BP and reducing the sequelae associated with HTN

Following a rigorous and comprehensive search of the evidence since 2001 a total of 12 studies

were identified One study was a meta-analysis while the remaining eleven studies were

Randomized Control Trials Evidence across the studies supported the utilization of APNs and

tele-monitoring to reduce HTN amongst AA men aged 40 years and older

Rosswurm and Larrabeersquos framework was chosen to guide the EBPCP The setting will be

a medium size solo family practice office A purposive sample of 60 AA men will be recruited by

two APNs during a routine family practice visit encouraging participation in the intervention The

EBPCP will consist of a tailored culturally sensitive educational intervention incorporating tele-

monitoring by APNs The intervention will be measured using various instruments including BP

and weight via anthropometric measures exercise pattern (Lorig et al 1996) diet type and

frequency (ordinal scale) medication adherence (Moriskyrsquos scale) smoking and alcohol

consumption (self-reported on a nominal scale) and patient satisfaction (investigator-developed

open-ended questionnaire) These will be measured at baseline and again at one month three

months and six months Donabedienrsquos evaluation model will be used to evaluate the intervention

Problem Statement

The problem of interest for the proposed practice change is hypertension (HTN) HTN is

the number one silent killer among adults in the United States (US) According to the Centers for

Disease Control and Prevention [CDC] (2012) African Americans [AA] (444) have the highest

prevalence of HTN compared to Whites (326) and Mexican Americans (283) The World

Health Organization [WHO] (2011) attributes HTN as the leading cause of cardiovascular mortality

worldwide In 2008 the prevalence of HTN among adults aged 18 years and older was 68 million

(31) and has shown no improvement in the past decade Less than half of those with HTN have

their condition under control It affects one in three adults in the US and contributes to one out of

every seven deaths and nearly half of all cardiovascular disease--related deaths in the US In the

state of Ohio HTN is more prevalent among men (331) compared to women (304) when

considering races AAs have a higher prevalence (404) compared to whites (311) In 2010 the

related health care cost of HTN in the US was about $766 billion (CDC 2011) The American

Heart Association Institute of Medicine WHO and Healthy People 2020 aim to reduce the

prevalence of hypertension by assessing high risk factors providing education and eliminating

gaps in the treatment plan Although research on treatments is advancing disparities in HTN

exists among AAs which indicates a need for more evidence based research to close this widening

gap

Healthy People 2020 have included HTN reduction among its objectives The baseline rate for this

decade was 299 The target rate is projected to be 269 with an estimated 10 improvement

(Department of Health and Human Services 2012) This goal cannot be accomplished without turning the

focus onto the population group with the highest prevalence of HTN in the US which is largely constituted

by AA males aged 40 years and older AAs develop high blood pressure (BP) more often and at an earlier

age compared to whites and Mexican Americans (CDC 2012)

The American Heart Association (2012) describes HTN as an abnormal high measurement of the

force exerted on the arterial walls by the blood pumped from the heart Optimal blood pressure is less than

12080 mmHg HTN is defined as a consistent elevation of the systolic BP above 140 mmHg and a diastolic

BP above 90 mmHg Consequently when HTN is left untreated after a while sequelae can be detrimental

and multiple systems can be affected such as cardiovascular neurology renal ophthalmology

reproductive and respiratory High risk factors for high BP are advancing age obesity males AA heritage

family history of hypertension atherosclerosis diabetes smoking high-salt diet excessive alcohol

consumption and emotional stress (National Institute of Health 2012)

The possible interventions to encounter HTN are (1) The Dietary Approaches to Stop

Hypertension (DASH) eating plan DASH is a simple heart healthy diet that can help prevent or lower high

BP This diet is low in sodium cholesterol saturated and total fat and high in fruits and vegetables fiber

potassium and low-fat dairy products (2) Monitoring BP is important because high BP often has no

symptoms One way to improve BP is by tele-monitoring patients in the convenience of their homes

Interventions that use home BP tele-monitoring linked with patient feedback and medication titration can

enhance access and improve outcomes for adults with HTN (Bosworth 2011) (3) Education regarding

lifestyle modification such as eating a healthy diet maintaining a healthy weight calculating and

maintaining body mass index (BMI) within normal range engaging in moderate physical activity smoking

cessation limiting alcohol and medication adherence (4) Preventing and managing diabetes (5) Treating

high BP with medications and stressing the importance of medication adherence (CDC 2012)

The principle goal of treating HTN is to reduce the sequelae associated with HTN and to prevent

multiple system damage Although the recommended intervention varies and is dependent on the patientrsquos

age and severity of HTN experts believe that innovative tailored culturally sensitive educational

interventions via tele-monitoring are most effective in reducing high BP Based on these recommendations

we propose a six-month tailored culturally-sensitive educational intervention incorporating tele-monitoring

by APNs employed by a private practice The educational intervention will include diet management

engaging in moderate physical activity weight control medication adherence and assessment of lifestyle

changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational

intervention of blood pressure management by APNs The proposed practice change delivered over a six-

month time period will be guided by asking clinical questions in PICOT format [P population of interest I

intervention or issue of interest C comparison of interest O outcome expected and T time for the

intervention to achieve the outcome] (Melnyk amp Fineout-Overholt 2011)

The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN

resulting in decreased HTN among AA males aged 40 years and older Based on these recommendations

our PICOT question is In hypertensive AA males aged gt 40 years (P) what is the efficacy of a tailored

culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in

comparison to standard educational intervention of blood pressure management by APNs (C) in reducing

blood pressure readings within normal range of lt 12080 mmHg (O) over a six month period (T) (see

Appendix A)

Planning the Practice Change Team

There are several disciplines that must be included in planning this practice change The APNs

physician staff nurses nursing assistants billing and clerical staff all need to have input into the best way

to integrate the proposed practice change into the patientrsquos plan of care By including all levels of staff in

the planning the best methods of implementing and monitoring alternate BP measurements can be

determined

The key informants in implementing this practice change will include all levels of staff within the

primary care practice The APNrsquos salary which is approximately $92000 per year will be prorated for one

dayweek to oversee the proposed practice change from the onset to conclusion and to maintain the

integrity of data collection and data analysisinterpretation The APN and physician need to give guidance

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

HYPERTENSION 2

Table of Contents

Cover pagehelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip1

Abstracthelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip3

Problem Statement helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip4-

6

Planning the Practice Change Team helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip6-8

Critical Appraisal of Evidence helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip8-

10

Plan a Pilot Test of the Change helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip10-15

Evaluation helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip15-18

Human Subjects Concerns helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip18-

19

Budget helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

19

Conclusionhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip19-20

References helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip21-23

Appendiceshelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip24-29

Appendix A helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip24

Appendix B helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip25

Appendix C hellip (refer to a separate document)helliphelliphelliphelliphelliphellip25

Appendix D helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip26

Appendix E helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip27

Appendix Fhelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip28

Appendix G helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip29

Abstract

According to the Centers for Disease Control and Prevention (2012) African Americans

[AA] (444) have the highest prevalence of hypertension (HTN) when compared to Whites

(326) and Mexican Americans (283) The research team proposed a culturally-sensitive

educational intervention via tele-monitoring delivered by Advance Practice Nurses (APNs) in a

private family practice setting The goal is to reduce blood pressure (BP) readings in AA males

aged gt 40 years to within normal range of lt 12080 mmHg over a six-month period Stakeholders

include patients family members physician APNs and private practice staff Resistance may

come from staff and APNs because of additional work responsibilities in managing patients

Strengths of change include decreasing BP and reducing the sequelae associated with HTN

Following a rigorous and comprehensive search of the evidence since 2001 a total of 12 studies

were identified One study was a meta-analysis while the remaining eleven studies were

Randomized Control Trials Evidence across the studies supported the utilization of APNs and

tele-monitoring to reduce HTN amongst AA men aged 40 years and older

Rosswurm and Larrabeersquos framework was chosen to guide the EBPCP The setting will be

a medium size solo family practice office A purposive sample of 60 AA men will be recruited by

two APNs during a routine family practice visit encouraging participation in the intervention The

EBPCP will consist of a tailored culturally sensitive educational intervention incorporating tele-

monitoring by APNs The intervention will be measured using various instruments including BP

and weight via anthropometric measures exercise pattern (Lorig et al 1996) diet type and

frequency (ordinal scale) medication adherence (Moriskyrsquos scale) smoking and alcohol

consumption (self-reported on a nominal scale) and patient satisfaction (investigator-developed

open-ended questionnaire) These will be measured at baseline and again at one month three

months and six months Donabedienrsquos evaluation model will be used to evaluate the intervention

Problem Statement

The problem of interest for the proposed practice change is hypertension (HTN) HTN is

the number one silent killer among adults in the United States (US) According to the Centers for

Disease Control and Prevention [CDC] (2012) African Americans [AA] (444) have the highest

prevalence of HTN compared to Whites (326) and Mexican Americans (283) The World

Health Organization [WHO] (2011) attributes HTN as the leading cause of cardiovascular mortality

worldwide In 2008 the prevalence of HTN among adults aged 18 years and older was 68 million

(31) and has shown no improvement in the past decade Less than half of those with HTN have

their condition under control It affects one in three adults in the US and contributes to one out of

every seven deaths and nearly half of all cardiovascular disease--related deaths in the US In the

state of Ohio HTN is more prevalent among men (331) compared to women (304) when

considering races AAs have a higher prevalence (404) compared to whites (311) In 2010 the

related health care cost of HTN in the US was about $766 billion (CDC 2011) The American

Heart Association Institute of Medicine WHO and Healthy People 2020 aim to reduce the

prevalence of hypertension by assessing high risk factors providing education and eliminating

gaps in the treatment plan Although research on treatments is advancing disparities in HTN

exists among AAs which indicates a need for more evidence based research to close this widening

gap

Healthy People 2020 have included HTN reduction among its objectives The baseline rate for this

decade was 299 The target rate is projected to be 269 with an estimated 10 improvement

(Department of Health and Human Services 2012) This goal cannot be accomplished without turning the

focus onto the population group with the highest prevalence of HTN in the US which is largely constituted

by AA males aged 40 years and older AAs develop high blood pressure (BP) more often and at an earlier

age compared to whites and Mexican Americans (CDC 2012)

The American Heart Association (2012) describes HTN as an abnormal high measurement of the

force exerted on the arterial walls by the blood pumped from the heart Optimal blood pressure is less than

12080 mmHg HTN is defined as a consistent elevation of the systolic BP above 140 mmHg and a diastolic

BP above 90 mmHg Consequently when HTN is left untreated after a while sequelae can be detrimental

and multiple systems can be affected such as cardiovascular neurology renal ophthalmology

reproductive and respiratory High risk factors for high BP are advancing age obesity males AA heritage

family history of hypertension atherosclerosis diabetes smoking high-salt diet excessive alcohol

consumption and emotional stress (National Institute of Health 2012)

The possible interventions to encounter HTN are (1) The Dietary Approaches to Stop

Hypertension (DASH) eating plan DASH is a simple heart healthy diet that can help prevent or lower high

BP This diet is low in sodium cholesterol saturated and total fat and high in fruits and vegetables fiber

potassium and low-fat dairy products (2) Monitoring BP is important because high BP often has no

symptoms One way to improve BP is by tele-monitoring patients in the convenience of their homes

Interventions that use home BP tele-monitoring linked with patient feedback and medication titration can

enhance access and improve outcomes for adults with HTN (Bosworth 2011) (3) Education regarding

lifestyle modification such as eating a healthy diet maintaining a healthy weight calculating and

maintaining body mass index (BMI) within normal range engaging in moderate physical activity smoking

cessation limiting alcohol and medication adherence (4) Preventing and managing diabetes (5) Treating

high BP with medications and stressing the importance of medication adherence (CDC 2012)

The principle goal of treating HTN is to reduce the sequelae associated with HTN and to prevent

multiple system damage Although the recommended intervention varies and is dependent on the patientrsquos

age and severity of HTN experts believe that innovative tailored culturally sensitive educational

interventions via tele-monitoring are most effective in reducing high BP Based on these recommendations

we propose a six-month tailored culturally-sensitive educational intervention incorporating tele-monitoring

by APNs employed by a private practice The educational intervention will include diet management

engaging in moderate physical activity weight control medication adherence and assessment of lifestyle

changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational

intervention of blood pressure management by APNs The proposed practice change delivered over a six-

month time period will be guided by asking clinical questions in PICOT format [P population of interest I

intervention or issue of interest C comparison of interest O outcome expected and T time for the

intervention to achieve the outcome] (Melnyk amp Fineout-Overholt 2011)

The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN

resulting in decreased HTN among AA males aged 40 years and older Based on these recommendations

our PICOT question is In hypertensive AA males aged gt 40 years (P) what is the efficacy of a tailored

culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in

comparison to standard educational intervention of blood pressure management by APNs (C) in reducing

blood pressure readings within normal range of lt 12080 mmHg (O) over a six month period (T) (see

Appendix A)

Planning the Practice Change Team

There are several disciplines that must be included in planning this practice change The APNs

physician staff nurses nursing assistants billing and clerical staff all need to have input into the best way

to integrate the proposed practice change into the patientrsquos plan of care By including all levels of staff in

the planning the best methods of implementing and monitoring alternate BP measurements can be

determined

The key informants in implementing this practice change will include all levels of staff within the

primary care practice The APNrsquos salary which is approximately $92000 per year will be prorated for one

dayweek to oversee the proposed practice change from the onset to conclusion and to maintain the

integrity of data collection and data analysisinterpretation The APN and physician need to give guidance

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

Appendix G helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip29

Abstract

According to the Centers for Disease Control and Prevention (2012) African Americans

[AA] (444) have the highest prevalence of hypertension (HTN) when compared to Whites

(326) and Mexican Americans (283) The research team proposed a culturally-sensitive

educational intervention via tele-monitoring delivered by Advance Practice Nurses (APNs) in a

private family practice setting The goal is to reduce blood pressure (BP) readings in AA males

aged gt 40 years to within normal range of lt 12080 mmHg over a six-month period Stakeholders

include patients family members physician APNs and private practice staff Resistance may

come from staff and APNs because of additional work responsibilities in managing patients

Strengths of change include decreasing BP and reducing the sequelae associated with HTN

Following a rigorous and comprehensive search of the evidence since 2001 a total of 12 studies

were identified One study was a meta-analysis while the remaining eleven studies were

Randomized Control Trials Evidence across the studies supported the utilization of APNs and

tele-monitoring to reduce HTN amongst AA men aged 40 years and older

Rosswurm and Larrabeersquos framework was chosen to guide the EBPCP The setting will be

a medium size solo family practice office A purposive sample of 60 AA men will be recruited by

two APNs during a routine family practice visit encouraging participation in the intervention The

EBPCP will consist of a tailored culturally sensitive educational intervention incorporating tele-

monitoring by APNs The intervention will be measured using various instruments including BP

and weight via anthropometric measures exercise pattern (Lorig et al 1996) diet type and

frequency (ordinal scale) medication adherence (Moriskyrsquos scale) smoking and alcohol

consumption (self-reported on a nominal scale) and patient satisfaction (investigator-developed

open-ended questionnaire) These will be measured at baseline and again at one month three

months and six months Donabedienrsquos evaluation model will be used to evaluate the intervention

Problem Statement

The problem of interest for the proposed practice change is hypertension (HTN) HTN is

the number one silent killer among adults in the United States (US) According to the Centers for

Disease Control and Prevention [CDC] (2012) African Americans [AA] (444) have the highest

prevalence of HTN compared to Whites (326) and Mexican Americans (283) The World

Health Organization [WHO] (2011) attributes HTN as the leading cause of cardiovascular mortality

worldwide In 2008 the prevalence of HTN among adults aged 18 years and older was 68 million

(31) and has shown no improvement in the past decade Less than half of those with HTN have

their condition under control It affects one in three adults in the US and contributes to one out of

every seven deaths and nearly half of all cardiovascular disease--related deaths in the US In the

state of Ohio HTN is more prevalent among men (331) compared to women (304) when

considering races AAs have a higher prevalence (404) compared to whites (311) In 2010 the

related health care cost of HTN in the US was about $766 billion (CDC 2011) The American

Heart Association Institute of Medicine WHO and Healthy People 2020 aim to reduce the

prevalence of hypertension by assessing high risk factors providing education and eliminating

gaps in the treatment plan Although research on treatments is advancing disparities in HTN

exists among AAs which indicates a need for more evidence based research to close this widening

gap

Healthy People 2020 have included HTN reduction among its objectives The baseline rate for this

decade was 299 The target rate is projected to be 269 with an estimated 10 improvement

(Department of Health and Human Services 2012) This goal cannot be accomplished without turning the

focus onto the population group with the highest prevalence of HTN in the US which is largely constituted

by AA males aged 40 years and older AAs develop high blood pressure (BP) more often and at an earlier

age compared to whites and Mexican Americans (CDC 2012)

The American Heart Association (2012) describes HTN as an abnormal high measurement of the

force exerted on the arterial walls by the blood pumped from the heart Optimal blood pressure is less than

12080 mmHg HTN is defined as a consistent elevation of the systolic BP above 140 mmHg and a diastolic

BP above 90 mmHg Consequently when HTN is left untreated after a while sequelae can be detrimental

and multiple systems can be affected such as cardiovascular neurology renal ophthalmology

reproductive and respiratory High risk factors for high BP are advancing age obesity males AA heritage

family history of hypertension atherosclerosis diabetes smoking high-salt diet excessive alcohol

consumption and emotional stress (National Institute of Health 2012)

The possible interventions to encounter HTN are (1) The Dietary Approaches to Stop

Hypertension (DASH) eating plan DASH is a simple heart healthy diet that can help prevent or lower high

BP This diet is low in sodium cholesterol saturated and total fat and high in fruits and vegetables fiber

potassium and low-fat dairy products (2) Monitoring BP is important because high BP often has no

symptoms One way to improve BP is by tele-monitoring patients in the convenience of their homes

Interventions that use home BP tele-monitoring linked with patient feedback and medication titration can

enhance access and improve outcomes for adults with HTN (Bosworth 2011) (3) Education regarding

lifestyle modification such as eating a healthy diet maintaining a healthy weight calculating and

maintaining body mass index (BMI) within normal range engaging in moderate physical activity smoking

cessation limiting alcohol and medication adherence (4) Preventing and managing diabetes (5) Treating

high BP with medications and stressing the importance of medication adherence (CDC 2012)

The principle goal of treating HTN is to reduce the sequelae associated with HTN and to prevent

multiple system damage Although the recommended intervention varies and is dependent on the patientrsquos

age and severity of HTN experts believe that innovative tailored culturally sensitive educational

interventions via tele-monitoring are most effective in reducing high BP Based on these recommendations

we propose a six-month tailored culturally-sensitive educational intervention incorporating tele-monitoring

by APNs employed by a private practice The educational intervention will include diet management

engaging in moderate physical activity weight control medication adherence and assessment of lifestyle

changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational

intervention of blood pressure management by APNs The proposed practice change delivered over a six-

month time period will be guided by asking clinical questions in PICOT format [P population of interest I

intervention or issue of interest C comparison of interest O outcome expected and T time for the

intervention to achieve the outcome] (Melnyk amp Fineout-Overholt 2011)

The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN

resulting in decreased HTN among AA males aged 40 years and older Based on these recommendations

our PICOT question is In hypertensive AA males aged gt 40 years (P) what is the efficacy of a tailored

culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in

comparison to standard educational intervention of blood pressure management by APNs (C) in reducing

blood pressure readings within normal range of lt 12080 mmHg (O) over a six month period (T) (see

Appendix A)

Planning the Practice Change Team

There are several disciplines that must be included in planning this practice change The APNs

physician staff nurses nursing assistants billing and clerical staff all need to have input into the best way

to integrate the proposed practice change into the patientrsquos plan of care By including all levels of staff in

the planning the best methods of implementing and monitoring alternate BP measurements can be

determined

The key informants in implementing this practice change will include all levels of staff within the

primary care practice The APNrsquos salary which is approximately $92000 per year will be prorated for one

dayweek to oversee the proposed practice change from the onset to conclusion and to maintain the

integrity of data collection and data analysisinterpretation The APN and physician need to give guidance

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

open-ended questionnaire) These will be measured at baseline and again at one month three

months and six months Donabedienrsquos evaluation model will be used to evaluate the intervention

Problem Statement

The problem of interest for the proposed practice change is hypertension (HTN) HTN is

the number one silent killer among adults in the United States (US) According to the Centers for

Disease Control and Prevention [CDC] (2012) African Americans [AA] (444) have the highest

prevalence of HTN compared to Whites (326) and Mexican Americans (283) The World

Health Organization [WHO] (2011) attributes HTN as the leading cause of cardiovascular mortality

worldwide In 2008 the prevalence of HTN among adults aged 18 years and older was 68 million

(31) and has shown no improvement in the past decade Less than half of those with HTN have

their condition under control It affects one in three adults in the US and contributes to one out of

every seven deaths and nearly half of all cardiovascular disease--related deaths in the US In the

state of Ohio HTN is more prevalent among men (331) compared to women (304) when

considering races AAs have a higher prevalence (404) compared to whites (311) In 2010 the

related health care cost of HTN in the US was about $766 billion (CDC 2011) The American

Heart Association Institute of Medicine WHO and Healthy People 2020 aim to reduce the

prevalence of hypertension by assessing high risk factors providing education and eliminating

gaps in the treatment plan Although research on treatments is advancing disparities in HTN

exists among AAs which indicates a need for more evidence based research to close this widening

gap

Healthy People 2020 have included HTN reduction among its objectives The baseline rate for this

decade was 299 The target rate is projected to be 269 with an estimated 10 improvement

(Department of Health and Human Services 2012) This goal cannot be accomplished without turning the

focus onto the population group with the highest prevalence of HTN in the US which is largely constituted

by AA males aged 40 years and older AAs develop high blood pressure (BP) more often and at an earlier

age compared to whites and Mexican Americans (CDC 2012)

The American Heart Association (2012) describes HTN as an abnormal high measurement of the

force exerted on the arterial walls by the blood pumped from the heart Optimal blood pressure is less than

12080 mmHg HTN is defined as a consistent elevation of the systolic BP above 140 mmHg and a diastolic

BP above 90 mmHg Consequently when HTN is left untreated after a while sequelae can be detrimental

and multiple systems can be affected such as cardiovascular neurology renal ophthalmology

reproductive and respiratory High risk factors for high BP are advancing age obesity males AA heritage

family history of hypertension atherosclerosis diabetes smoking high-salt diet excessive alcohol

consumption and emotional stress (National Institute of Health 2012)

The possible interventions to encounter HTN are (1) The Dietary Approaches to Stop

Hypertension (DASH) eating plan DASH is a simple heart healthy diet that can help prevent or lower high

BP This diet is low in sodium cholesterol saturated and total fat and high in fruits and vegetables fiber

potassium and low-fat dairy products (2) Monitoring BP is important because high BP often has no

symptoms One way to improve BP is by tele-monitoring patients in the convenience of their homes

Interventions that use home BP tele-monitoring linked with patient feedback and medication titration can

enhance access and improve outcomes for adults with HTN (Bosworth 2011) (3) Education regarding

lifestyle modification such as eating a healthy diet maintaining a healthy weight calculating and

maintaining body mass index (BMI) within normal range engaging in moderate physical activity smoking

cessation limiting alcohol and medication adherence (4) Preventing and managing diabetes (5) Treating

high BP with medications and stressing the importance of medication adherence (CDC 2012)

The principle goal of treating HTN is to reduce the sequelae associated with HTN and to prevent

multiple system damage Although the recommended intervention varies and is dependent on the patientrsquos

age and severity of HTN experts believe that innovative tailored culturally sensitive educational

interventions via tele-monitoring are most effective in reducing high BP Based on these recommendations

we propose a six-month tailored culturally-sensitive educational intervention incorporating tele-monitoring

by APNs employed by a private practice The educational intervention will include diet management

engaging in moderate physical activity weight control medication adherence and assessment of lifestyle

changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational

intervention of blood pressure management by APNs The proposed practice change delivered over a six-

month time period will be guided by asking clinical questions in PICOT format [P population of interest I

intervention or issue of interest C comparison of interest O outcome expected and T time for the

intervention to achieve the outcome] (Melnyk amp Fineout-Overholt 2011)

The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN

resulting in decreased HTN among AA males aged 40 years and older Based on these recommendations

our PICOT question is In hypertensive AA males aged gt 40 years (P) what is the efficacy of a tailored

culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in

comparison to standard educational intervention of blood pressure management by APNs (C) in reducing

blood pressure readings within normal range of lt 12080 mmHg (O) over a six month period (T) (see

Appendix A)

Planning the Practice Change Team

There are several disciplines that must be included in planning this practice change The APNs

physician staff nurses nursing assistants billing and clerical staff all need to have input into the best way

to integrate the proposed practice change into the patientrsquos plan of care By including all levels of staff in

the planning the best methods of implementing and monitoring alternate BP measurements can be

determined

The key informants in implementing this practice change will include all levels of staff within the

primary care practice The APNrsquos salary which is approximately $92000 per year will be prorated for one

dayweek to oversee the proposed practice change from the onset to conclusion and to maintain the

integrity of data collection and data analysisinterpretation The APN and physician need to give guidance

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

by AA males aged 40 years and older AAs develop high blood pressure (BP) more often and at an earlier

age compared to whites and Mexican Americans (CDC 2012)

The American Heart Association (2012) describes HTN as an abnormal high measurement of the

force exerted on the arterial walls by the blood pumped from the heart Optimal blood pressure is less than

12080 mmHg HTN is defined as a consistent elevation of the systolic BP above 140 mmHg and a diastolic

BP above 90 mmHg Consequently when HTN is left untreated after a while sequelae can be detrimental

and multiple systems can be affected such as cardiovascular neurology renal ophthalmology

reproductive and respiratory High risk factors for high BP are advancing age obesity males AA heritage

family history of hypertension atherosclerosis diabetes smoking high-salt diet excessive alcohol

consumption and emotional stress (National Institute of Health 2012)

The possible interventions to encounter HTN are (1) The Dietary Approaches to Stop

Hypertension (DASH) eating plan DASH is a simple heart healthy diet that can help prevent or lower high

BP This diet is low in sodium cholesterol saturated and total fat and high in fruits and vegetables fiber

potassium and low-fat dairy products (2) Monitoring BP is important because high BP often has no

symptoms One way to improve BP is by tele-monitoring patients in the convenience of their homes

Interventions that use home BP tele-monitoring linked with patient feedback and medication titration can

enhance access and improve outcomes for adults with HTN (Bosworth 2011) (3) Education regarding

lifestyle modification such as eating a healthy diet maintaining a healthy weight calculating and

maintaining body mass index (BMI) within normal range engaging in moderate physical activity smoking

cessation limiting alcohol and medication adherence (4) Preventing and managing diabetes (5) Treating

high BP with medications and stressing the importance of medication adherence (CDC 2012)

The principle goal of treating HTN is to reduce the sequelae associated with HTN and to prevent

multiple system damage Although the recommended intervention varies and is dependent on the patientrsquos

age and severity of HTN experts believe that innovative tailored culturally sensitive educational

interventions via tele-monitoring are most effective in reducing high BP Based on these recommendations

we propose a six-month tailored culturally-sensitive educational intervention incorporating tele-monitoring

by APNs employed by a private practice The educational intervention will include diet management

engaging in moderate physical activity weight control medication adherence and assessment of lifestyle

changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational

intervention of blood pressure management by APNs The proposed practice change delivered over a six-

month time period will be guided by asking clinical questions in PICOT format [P population of interest I

intervention or issue of interest C comparison of interest O outcome expected and T time for the

intervention to achieve the outcome] (Melnyk amp Fineout-Overholt 2011)

The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN

resulting in decreased HTN among AA males aged 40 years and older Based on these recommendations

our PICOT question is In hypertensive AA males aged gt 40 years (P) what is the efficacy of a tailored

culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in

comparison to standard educational intervention of blood pressure management by APNs (C) in reducing

blood pressure readings within normal range of lt 12080 mmHg (O) over a six month period (T) (see

Appendix A)

Planning the Practice Change Team

There are several disciplines that must be included in planning this practice change The APNs

physician staff nurses nursing assistants billing and clerical staff all need to have input into the best way

to integrate the proposed practice change into the patientrsquos plan of care By including all levels of staff in

the planning the best methods of implementing and monitoring alternate BP measurements can be

determined

The key informants in implementing this practice change will include all levels of staff within the

primary care practice The APNrsquos salary which is approximately $92000 per year will be prorated for one

dayweek to oversee the proposed practice change from the onset to conclusion and to maintain the

integrity of data collection and data analysisinterpretation The APN and physician need to give guidance

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

we propose a six-month tailored culturally-sensitive educational intervention incorporating tele-monitoring

by APNs employed by a private practice The educational intervention will include diet management

engaging in moderate physical activity weight control medication adherence and assessment of lifestyle

changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational

intervention of blood pressure management by APNs The proposed practice change delivered over a six-

month time period will be guided by asking clinical questions in PICOT format [P population of interest I

intervention or issue of interest C comparison of interest O outcome expected and T time for the

intervention to achieve the outcome] (Melnyk amp Fineout-Overholt 2011)

The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN

resulting in decreased HTN among AA males aged 40 years and older Based on these recommendations

our PICOT question is In hypertensive AA males aged gt 40 years (P) what is the efficacy of a tailored

culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in

comparison to standard educational intervention of blood pressure management by APNs (C) in reducing

blood pressure readings within normal range of lt 12080 mmHg (O) over a six month period (T) (see

Appendix A)

Planning the Practice Change Team

There are several disciplines that must be included in planning this practice change The APNs

physician staff nurses nursing assistants billing and clerical staff all need to have input into the best way

to integrate the proposed practice change into the patientrsquos plan of care By including all levels of staff in

the planning the best methods of implementing and monitoring alternate BP measurements can be

determined

The key informants in implementing this practice change will include all levels of staff within the

primary care practice The APNrsquos salary which is approximately $92000 per year will be prorated for one

dayweek to oversee the proposed practice change from the onset to conclusion and to maintain the

integrity of data collection and data analysisinterpretation The APN and physician need to give guidance

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

on clinically acceptable BP readings and pharmacological management of HTN The staff nurses need to

provide information on the techniques on BP monitoring as well as support staff teaching Clerical staff and

nursing assistants will play an important role by providing feedback regarding the charting system and the

ease of being able to gather and provide information about BP readings from the patients to the APN

Finally the billing staff needs to provide information about the proper billing for in office versus in home BP

monitoring The practice change team will work once per week to coordinate the change process The

setting for the proposed practice change will be a medium size solo family practice office in a moderate size

city in the Midwest with a large or rapidly growing population of AAs

No participants from outside agencies will be involved in the implementation of this practice

change The monitoring of BP will be done by APNs The practice staff will monitor all interventions

Critical Appraisal of Evidence

Multiple sources of evidence have contributed to the development of the proposed evidence based

practice change These sources include one Cochrane meta-analyses review and eleven randomized

controlled trials The collection of evidence was obtained following an extensive literature review using the

following databases Cochrane CINAHL PubMed MEDLINE and PsycINFO The literature search was

derived from the following key words hypertension blood pressure usual care for hypertension tele-

monitoring telemedicine nurse practitioner advanced practice nurse and African Americans

Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs Eighty

articles were reviewed however a majority was eliminated because they were greater than 12 years old

the sample size was too small they did not completely fit the aforementioned criteria for the proposed

practice change or they were lower levels of evidence The synthesis of evidence and strength of the

evidence tables are provided in Appendix B and C

Jaana Pare and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home

blood pressure monitoring via tele-monitoring towards the reduction of HTN Jaana Pare and Sicottes

(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

clinical settings In addition to a reduction of HTN the utilization of home BP monitoring was also shown to

be beneficial in the identification of lsquoWhite coat syndromersquo Identification of lsquoWhite coat syndromersquo can

prevent over treatment of patients with anti-hypertensive medications Artinian Washington and Templin

(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the

usual care for BP management would reduce BP more than in those who just receive the usual care

Artinian (2001) concluded that patientsrsquo who received tele-monitoring in addition to the usual care

yielded the most significant reduction in BP over the course of the clinical trial In 2007 Artinian Flack

Nordstrom Hockman Washington Jen and Fathy built off the previously mentioned study performing a

RCT on AAs with HTN This study was comparing patients who received usual care to those patients who

received tele-monitoring in addition to usual care for BP management Artinian et al (2007) concluded that

those patients who received the usual care and tele-monitoring experienced a more significant decrease in

BP than the control group

Continuing to evaluate usual care McManus Mant Bray Holder Jones Greenfield Kaambwa

Bryan Little Williams and Hobbs (2010) performed a RCT on 527 hypertensive adults in England The

study was comparing the usual care provided by family physicians to patient self-management via tele-

monitoring The study concluded that over a monitoring period of one year those who received the self-

management intervention via tele-monitoring realized a greater reduction in BP when compared to those

with usual care Parati Omboni Albini Piantoni Giuliano Revera Illyes and Mancia (2009) performed a

RCT to compare patients who received usual care for HTN management to those patients who utilized

tele-monitoring for HTN management Parati et al (2009) concluded that those individuals in which tele-

monitoring were the main intervention experienced an overall greater reduction in HTN than those with

usual care

Brennan Spettell Villagra Ofili McMahill-Walraven Lowy Daniels Quarshie and Mayberry (2010)

performed a RCT on 954 hypertensive AA males This study compared the management of HTN by a

telephonic nurse and in home BP monitoring against those with just in home BP monitoring Brennan et al

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

(2010) concluded that patients who received telephonic nurse intervention combined with in home BP

monitoring had a significant decrease in overall BP when compared to those that just had in home BP

monitoring Continuing to evaluate the effects of tele-monitoring in AAs McCant Mckoy Grubber Olsen

Oddone Powers and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring

among primary care patients with poor BP control Of the 588 participants 147 patients were randomized

to usual care The remaining 441 patients were randomized to receive either (1) a nurse-administered

tailored behavioral intervention (2) a nurse-administered medication management according to a

hypertension decision support system and (3) a combination of these two interventions McCant et al

(2009) concluded that 75 of patients were able to use tele-monitoring devices appropriately

Bosworth Powers Olsen McCant Grubber Smith Gentry Rose Houtven Wang Goldstein and

Oddone (2011) performed a RCT that examined the effects of a patient behavioral management

intervention medication management and a combination of the 2 interventions delivered by telephone and

activated by home BP monitoring among adults with HTN treated in primary care Bosworth et al (2009)

concluded that patients whose BP was poorly controlled at baseline exhibited a significant reduction in BP

with the combination of behavioral and medication management Hacihasanoğlu and Goumlzuumlm (2011)

echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in

Turkey The study concluded that targeted education from nurses resulted in a significant decrease in BP

when compared to those with usual care

Hill Han Dennison Kim Roary Blumenthal Bone Levine and Post (2003) performed a RCT on

309 hypertensive AA men This study compared the management of HTN by a team composed of a nurse

practitioner community health worker and physician with that of traditional care found in the community

After 36 months of evaluation Hill et al concluded that intervention delivered by the team of healthcare

providers was much more effective at lowering BP than the traditional care received Allen Dennison-

Himmelfarb Szanton Bone Hill Levine West Barlow Lewis-Boyer Donnelly-Strozzo Curtis and

Andersonrsquos (2011) RCT produced similar results The study concluded that interventions delivered by a

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors

than usual care

Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D) it

can be concluded that there is strong evidence to support the utilization of advanced practice nurses and

tele-monitoring to reduce HTN amongst African American men aged 40 years and older

Plan a Pilot Test for the Change

After review of several theoretical frameworks Rosswurm and Larrabeersquos framework was chosen

to guide the EBP proposal The framework involves six steps (1) assessing the need for change (2)

locating evidence (3) analyzing the evidence (4) designing a practice change (5) implementing the

practice change and (6) maintaining the change (Melnyk amp Fineout-Overholt 2011) This model was

selected because it is simple easy to understand and comprise steps that suitably fit this research project

The specific aim of the EBPCP is to implement a tailored culturally-sensitive educational

intervention incorporating BP management via tele-monitoring by APNs employed by the private practice

The educational intervention also includes diet management increasing physical activity weight control

medication adherence and assessment of lifestyle changes that will offer adequate control of HTN among

AA males aged 40 years and older

The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in

a moderate size city in the Midwest The practice is run by one physician and two APNs The practice is

surrounded by small business complexes with convenience parking accessible to main roads and interstate

highways Nearby residential areas are within a quarter mile of the family practice office in all directions

The nearest healthcare facilities including a moderate hospital dentist office and moderate nursing home

are within two miles along the main road on either direction The practice site serves between 6000 and

8000 visits per year of 90 indigent AA patients ranging from minor seasonal flu complaints and allergies

to severe and life-threatening events from chronic disease complications requiring referrals to hospitals

management of acute and minor illnesses in adults aged18 years and older

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

The EBPCP has been endorsed by the owner of the practice (physician) and his associates

(APNs) because the EBPCP will augment current health care of this vulnerable population The only

resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine

activities However after the introduction of the benefits of the EBPCP and addressing the questions and

concerns of nursing staff it is anticipated that the EBPCP will gain support because it will help nurses to

provide evidence based practice improvements in outcomes of AAs with HTN

PopulationSample

Last yearrsquos patient population at this practice was reported to be 7058 visits 89 (6300) were

AAs This estimates to about 117 AAs seen per week at this practice for health care services or about 19

AAs per day with the exception of Sunday when the practice is closed Of the 6300 visits half were AA

males ages 40 years and older Considering such a high percentage of AA patients seen in this practice on

a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males

with HTN into the EBPCP during the 6-months data collection period

Sampling plan

The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving

routine and follow-up care for management of HTN at the family practice office (eligibility criteria) Their

care at the practice creates the target population from which the sample will be drawn The sample will

include AA males ages 40 years and older who meet the following inclusion criteria (1) have a systolic

blood pressure reading gt 140 mmHg andor diastolic blood pressure reading gt 90 mmHg on two separate

occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure gt

130 mm Hg systolic andor diastolic blood pressure gt 80 mm Hg for potential candidate with diabetes or

chronic kidney disease and (3) able to read and speak English Exclusion criteria include (1) age less than

40 years (2) females (3) inability to read and speak English (4) non- AAs and (5) children Purposive

sampling will target all available AA males who will meet the above inclusion criteria The total number of

subjects in the study is 50 Over sampling will occur by 20 to account for attrition (N=60)

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

Recruitment procedures

A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are

practicing at the family practice office and inform them of the proposed EBPCP They will be instructed to

invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their

questions and concerns before proceeding with the proposed practice change Non- RNs will be informed

to post the EBPCP on the information board and to notify RNs of potential candidates The RN will be

instructed to initiate the study purpose and invite eligible patients into the study prior to or following the

initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of

the visit and the present conditions of the candidate AA males ages 40 years and older who meet inclusion

criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA

males ages 40 years and older

The APN will obtain the patientrsquos written signature on the Informed Consent (IC) on WSU

letterhead from willing participants after explanation about benefits versus risks of EBPCP The participants

will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP The

APN will provide explanation regarding BP and weight assessment using anthropometric measures and

about the types of questions that the candidates will answer and how long it will take to complete the

questionnaire(s) In addition the APN will assess for questions or concerns from the participants The

original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a

member of the EBPCP to collect once a week

Patients will be given a $15 gift card to Walmartrsquos store for participation in the questionnaire

(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP

Recruitment into the EBPCP will continue until the desired number of participants has been recruited into

the EBPCP A member of EBPCP will have a contact number to be reached at all time for questions and

concerns by the APNs andor the practice administration

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

The EBPCP will consist of a tailored culturally sensitive education intervention incorporating tele-

monitoring by APNs employed by the private practice The educational intervention will include diet

management physical activity weight control medication adherence and assessment of lifestyle changes

The intervention will be measured using various instruments including BP and weight via anthropometric

measures exercise pattern (Lorig et al 1996) diet type and frequency (ordinal scale) medication

adherence (Moriskyrsquos scale) and smoking and alcohol consumption (self-reported on a nominal scale) the

later scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1[kappa statistics] and

078-096[Spearman Rho correlation] Only the overall content validity and reliability of the questionnaire

was reported by the author in the literature Individual scale validity and reliability of the exercise scale and

medication adherence scale was not reported in the literature In addition we plan to use a questionnaire

developed by the team incorporating three open ended questions about the participantsrsquo satisfaction with

the educational intervention

Resistance might come from the staff because the EBPCP may incorporate new protocol and

development of new policies regarding the management or education of AA males with HTN The purposed

changes may create stress and provoke resistance to APNs because of additional work responsibilities in

managing patients With the help of the physician and APNs changes can be made incrementally and

adequate education about linkage of the benefits of the EBPCP resulting in better patientsrsquo outcomes

Implementation of the change may require special accommodations such as extra time for

collecting data and educating patients It is also paramount to consider additional time commitment for the

patients when participating in the proposed educational practice change Special accommodations and

flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP

The proposed practice change will occur incrementally during a six-month time period Please refer

to the Gantt chart for the proposed timeline (Appendix D) During the first month permission will be

obtained from the practice administration to conduct the EBPCP Stakeholders will get involved with the

introduction of PICOT question Identification of supporters and laggards will be determined Education

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member

of the EBPCP The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek

their support for this practice change and to determine if they have concerns about the feasibility of carrying

out this practice change An open-ended interview guide will be developed by the team to determine patient

satisfaction with the proposed educational intervention (See appendix for questions)

Assessment of the practice will be conducted to develop an appropriate strategy for the change The

budget will be determined and funds allocated (see Appendix E) Patients who have met the inclusion

criteria and who are interested in the educational intervention will be phased in to the EBPCP during the

second through fifth month During this time period the APNs will determine data from the patientrsquos chart to

be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical

analyses A formative evaluation will be done to determine the progress of the EBPCP and adjustments will

be made depending on the results During the sixth month of the EBPCP summative evaluation will be

conducted and data will be analyzed to determine the results of the EBPCP

Successful strategies that will help persuade others to support arguments behind the EBPCP will

include providing opportunity to discuss others concerns addressing their questions and continuously

providing accurate information about the benefit of EBP Communicating with the FNPs periodically will be

helpful in determining any identified problems in implementing the EBPCP and if so the recommendations

they have to improve or halt any lack of success in carrying this out Providing education to all

stakeholders about EBP and following a SWOT analysis process by identifying strengths weaknesses

opportunities for success and delineating the threats or barriers with strategies to overcome them will be

beneficial in making this EBPCP a success This strategic plan will help to share the vision of the EBPCP

to overcome barriers to promote engagement of staff and key stakeholders and to establish incremental

goals for all people involved

Evaluation

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

The outcomes that will be measured in this EBPCP are blood pressure self-reported exercise

pattern weight self-reported diet frequency and portion control medication adherence self-reported

cigarette and alcohol use and patient satisfaction All of these outcomes will be measured at baseline and

again at one month three months and six months from the commencement of the educational intervention

The outcomes will be measured using various instruments including blood pressure and weight via

anthropometric measures exercise pattern (Lorig et al 1996) self-reported diet type and frequency

(ordinal scale) medication adherence (Moriskyrsquos scale) and smoking and alcohol consumption (nominal

scale) The latter scalersquos content validity was 086 and inter-rater reliability ranged from 089 to 1 [kappa

statistics] amp 078-096 [Spearman Rho correlation] Only the overall content validity and reliability of the

questionnaire was reported by the author in the literature Individual scale validity and reliability of the

exercise scale and medication adherence scale was not reported in the literature In addition we plan to

use the three-item open-ended interview guide developed by the team to ascertain the participantsrsquo

satisfaction with the educational intervention

The primary outcome of the study will be BP control measured at baseline one month three

months and six months using a standardized research protocol At each measurement point the APN will

ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital

sphygmomanometer The participant will be weighed using a digital weighing scale During the same visit

participants will be asked to complete a structured 24-item questionnaire comprising four sections-

demographic profile lifestyle behavior (smoking drinking exercise and dietary habits) self-health

monitoring practices and medication adherence Demographic profile will include age gender educational

status marital status insurance and total household income Lifestyle behaviors- This section of the

questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a

nominal scale Exercise scale modified from Lorig et al (1996) will be used to assess exercise pattern

Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale

Dietary intake will be assessed by asking the type portion size and frequency of food on an ordinal scale

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular

self-health checking via tele-monitoring on BP and maintained records The measurement scale will be

dichotomous

Medication adherence will be assessed using Moriskyrsquos (1986) scale composed of 4 dichotomous

questions about medication use patterns The scale is quick and simple to use for subjects to indicate their

adherence to the physicianrsquos instructions A summative score will be calculated to reflect the level of

medication compliance A low score indicates high medication adherence

Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo

family practice Eligible patients will be invited to participate in the educational intervention Following the

invitation eligible patients will be asked to complete the questionnaires which can be completed in 25

minutes Privacy will be provided in a quiet area of the private practice office during the completion of the

questionnaire All questions will be answered by the APN The APN will also weigh the participant on a

digital weighing scale and record the weight

Donabedienrsquos (1982) program evaluation framework will guide this six-month educational

intervention The framework includes four elements structure process outcome and impact Structure

includes the social and physical resources in place to support the proposal EBPCP Process incorporates

what will occur during the EBPCP Outcomes include the early expectations after the practice change

whereas impact refers to the long term effects of the practice change measured against the ldquogold

standardsrdquo such as clinical practice standards developed by the American Heart Association in year 2012

For the purpose of this EBPCP we plan to incorporate the outcome during the six-month

educational intervention As a result of this practice change positive outcomes will be measured and

achieved by assessment of the following Decrease of blood pressure to within normal range lt12080

mmHg patients will report better lifestyle choices through selection of adherence to DASH increase in

physical activity weight control medication adherence and lifestyle changes (smoking cessation and

limited alcohol consumption) and an increase in patient satisfaction The Donabedienrsquos program evaluation

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

framework was chosen because it is simple and easy to understand and it includes the outcome element

among its evaluation strategy which is the main focus of this EBPCP

The practice change will be monitored by ascertaining changes in blood pressure self-reported

changes in adherence to DASH diet increase in physical activity weight control via anthropometric

measures medication adherence lifestyle changes (smoking cessation and limited alcohol consumption)

incrementally and over the six-month educational intervention Creating small successes along the way will

help in implementing the change For example during the six-month time period we will ask the patient

how they are managing behavioral lifestyles as measured by the stated measures

The long term effects of the practice change will be monitored by quarterly audits of charts to

evaluate the variables of interest When patients come back for regular follow up care BP readings within

normal range of 12080 mmHg will indicate that the practice change was successful in maintaining long-

term effects Patients who are unsuccessful in maintaining the practice change can be reeducated and

empowered Every six months the APNs will make phone calls to the patients and enquire regarding their

health status This will help nourish the new culture to make the change last

Success of the practice change project will be determined by the teamrsquos observation of changes in

the patientrsquos BP measurement and self-reported changes in adherence to the DASH diet increase in

physical activity weight loss smoking cessation decreased alcohol consumption and an increase in

patient satisfaction

This study will use non-parametric statistics (mean median mode range standard deviation

and frequency) to measure its variables and parametric statistics- analysis of variance (ANOVA) will be

used to measure four dependent variables including a decrease in SBP amp DBP adherence to DASH

increase in physical activity and a decrease in weight Data entry and interpretation will be done by WSU

Statistical Consultant Center in consultation with the researcher

Human Subjects

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

Educational interventions will be screened by Expedited IRB at WSU However the Review Board

or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior

to implementation of the proposed educational practice change with the goal of providing adequate

management of HTN among AA males aged 40 years and older The proposed practice change will consist

of an educational component as reported in the literature to improve health outcomes associated with HTN

among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team

The data collected will be kept in the small locked file cabinet located in the practicersquos office only

accessible to the EBPCP team members and the APNs involved for statistical analyses Confidentiality and

anonymity will be kept as established by the practice and by the research protocol if any publication of

results will be done to disseminate information

Budget

Funding will be received from the American Heart Association National Clinical Research Program

This grant offers $77000 for two years to practitioners offering clinical studies that will promote

cardiovascular health This amount will be used for equipment and additional staffing to support the

increased level of blood pressure monitoring The APNs salary which is approximately $92000 per year will

be prorated for one dayweek which is approximately $9200 over a period of six months

The budget will be split in the following manner 50 will go to additional staffing and APNs salary

25 to purchasing equipment and updating the practice computer system to work with the tele-monitoring

system 15 to additional supplies needed to be able to take appropriate blood pressure measurements

and 10 for travel to patients homes for set up of the tele-monitoring system and patient education This is

shown as a pie chart in Appendix F

The cost of implementing this practice change will be higher in the first year due to the technology

updates that will be required This cost will decrease with time The cost will be justified if the intended

results of normal blood pressure for the patients of the practice and if the sequelae associated with high

blood pressure are reduced

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

Conclusion

Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the

strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as

successful patient-management approach Improving the rate of blood pressure control for the AA male

population aged gt 40 years will help in preventing the sequelae associated with HTN and improve quality of

life Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance

required for timely interventions for BP control although it may be more resource intensive than traditional

clinic visits

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

HYPERTENSION 20

References

Allen JK Dennison-Himmelfarb CR Szanton SL Bone L Hill MN Levine DM West M

BarlowA Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011) Community

Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse

PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban

Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

American Heart Association (2012) Understanding blood pressure readings Retrieved March 5 2012

from httpwwwheartorgHEARTORGConditionsHighBloodPressureAboutHighBloodPressure

Understanding-Blood-Pressure-Readings_UCM_301764_Articlejsp

Artinian NT Flack JM Nordstrom CK Hockman EM Washington OGM Jen KC amp Fathy M (2007) Effects

of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African

Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-

based monitoring on blood pressure control in urban African Americans A pilot study Heart and

Lung Journal 30(3) 191-199

Bosworth H B Powers B J Olsen M K McCant F Grubber J Smith V Gentry P W Rose C

Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure

management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-

1180

Brennan T Spettell C Villagra V Ofili E McMahill-Walraven C Lowy E hellip Mayberry R (2010)

Disease management to promote blood pressure control among African Americans Population

Health Management Journal 13(2) 65-72 doi 101089pop20090019

Center for Disease Control and Prevention (2011) Trends in the prevalence of high blood pressure

Retrieved from httpwwwcdcgovnchsdatadatabriefsdb48pdf

Centers for Disease Control and Prevention (2012) About the National Center for Health Statistics

Retrieved March 5 2012 from httpwwwcdcgovnchsabouthtm

Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on

medication compliance hypertension management healthy lifestyle behaviors and BMI in a

primary health care setting Journal of Clinical Nursing 20(56) 692-705

Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and

psychological outcomes at 36 months American Journal of Hypertension 16 906-913

doi101016S0895-7061(03)01034-3

Institute of Medicine (2010) A Population-Based Policy and Systems Change Approach to

Prevent and Control Hypertension Retrieved January 25 2012 from

httpiomeduReports2010A-Population-Based-Policy-and-Systems-Change-Approach-to-

Prevent-and-Control-Hypertensionaspx

Jaana M Pare G amp Sicotte C (2007) Hypertension home telemonitoring Current evidence and

recommendations for future studies Disease Management and Health Outcomes 15 (1) 19-31

McCant F Mckoy G Grubber J Olsen M K Oddone E Powers B amp Bosworth H B (2009)

Feasibility of blood pressure telemonitoring in patients with poor blood pressure control Journal of

Telemedicine and Telecare 15 282-285

McManus RJ Mant J Bray EP Holder R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams

B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension

(TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-

6736(10)60964-6

Melnyk B M amp Fineout-Overholt E (2011) Evidence based practice in nursing and healthcare A guide

to best practice (2nd ed) Philadelphia PA Lippincott Williams amp Williams

National Institutes of Health (2012) Hypertension Retrieved March 29 2012 from

httpwwwnlmnihgovmedlineplusencyarticle000468htm

Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood

pressure telemonitoring improves hypertension control in general practice The Tele-BP Care

study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their

caregivers a pilot randomized controlled trial Progress in Cardiovascular Nursing 23(1) 18-26

United States Department of Health and Human Services (2012) Healthy People 2020 Retrieved from

httpwwwhealthypeoplegov2020defaultaspx

World Health Organization (2011) Hypertension Fact sheet Retrieved January 19 2012 from

httpwwwsearowhointlinkfilesnon_communicable_disases_hypertesnion-fspdf

Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood

pressure telemonitoring improves hypertension control in general practice The Tele-BP Care

study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their

caregivers a pilot randomized controlled trial Progress in Cardiovascular Nursing 23(1) 18-26

United States Department of Health and Human Services (2012) Healthy People 2020 Retrieved from

httpwwwhealthypeoplegov2020defaultaspx

World Health Organization (2011) Hypertension Fact sheet Retrieved January 19 2012 from

httpwwwsearowhointlinkfilesnon_communicable_disases_hypertesnion-fspdf

HYPERTENSION 23

Appendix A

Table 1

PICOT TABLE

Problem Affecting the PatientPopulation

Intervention Comparison Outcome Time

Hypertension is a medical condition that is highly prevalent among African-Americans (AA) males ages 40 years and older compared to other minority population groups or Whites of similar ages in the United States

A tailored culturally-sensitive educational intervention incorporating blood pressure management via tele-monitoring by Advance Practice Nurses (APNrsquos) includingDiet management (DASH)Increasing Physical activityWeight controlMedication adherenceLifestyle changes

MeasurementInstrumentationBlood pressure amp weight via anthropometric measuresExercise pattern-Lorig et al (1996)Diet portion control type amp frequency- ordinal scaleMedication adherence- Moriskyrsquos scaleCigarette amp alcohol use self-reported on a nominal scaleValidity Examined by three experts overall content validity was 086Reliability The inter-rater reliability ranged from 089 to 1 (kappa statistics) amp078-096 (Spearman Rho correlation)

Only the overall content validity and reliability of the questionnaire was reported by the author in the literature Individual validity and reliability of the exercise scale and medication adherence scale was not reported in the literature

Standard educational intervention of blood pressure measurement by APNs

Blood pressure readings within normal range of lt 12080 mmHg (considered normal range according to the most recent guidelines from the American Heart Association 2011)

Over a six month period in monthly visits

PICOT question In hypertensive African-American males aged gt 40 years (P) what is the efficacy of a

tailored culturally-sensitive educational intervention via tele-monitoring by APNs (I) in comparison to

standard educational intervention of blood pressure management by APNs (C) in reducing blood pressure

readings within normal range of less than 12080 mm Hg (O) over a six month period (T)

HYPERTENSION 24

Appendix B

Table 1 ndash Evaluation Table of the Level of Evidence

Citation amp study Designmethodie meta-analyses or meta-synthesis from Cochrane database

SampleSetting Major variables studied

Measurement or instruments ie observation or psychometric tools or scales

Data analysis ie Confidence interval = briefly discuss)

Researchers or authorsrsquo expected or anticipated outcomes

Findings or results

Appraisal Worth to practiceS=strengths versus W=weaknesses or L=limitations of the study

1 Jaana M Pare G amp Sicotte C (2007) Hypertension home telemonitoring Current evidence and recommendations for future studies Disease Management and Health Outcomes 15 (1) 19-31

Meta-analysis from Cochrane database

14 studies investigating the use of home BP telemonitoring that were found in the scientific literature of which only three were randomized trials

The studies present evidence on the benefits of telemonitoring as a patient-management approach and their condition such as significant BP control better medication adherence changes in patientsrsquo lifestyle as well as their attitudes and behaviors

Comparing results of all the 14 studies

The findings of all the 14 studies were analyzed and compared

Home telemonitoring to support hypertension control by allowing fast interventions and adjustments in both treatment and medications improving patientsrsquo compliance and communication with their practitioners as well as reduce the lsquowhite coatrsquo effect(White coat effect-is defined as reproducible hypertension in the medical setting and normotension in the non-medical setting)

A meta-analysis on the monitoring of BP indicates that the control of BP is better achieved when measured at home as opposed to in clinical settings especially in cases of low medication compliance co morbidities and uncontrolled hypertension The electronic transmission of data from home BP monitoring allowed regular communication with healthcare providers and supports reliable readings that

StrengthsTelemonitoring of patients with HTN appears to be an effective patient-management approach that supports BP control assists in identifying patients with the white coat effect and as such reduces the risk of over-treatment HTN telemonitoring supports patientsrsquo empowerment and reassurance by giving them direct responsibility for continuous monitoring of the BP and by ensuring regular communication with health care providers and immediate feedback even outside office hours and in remote areasWeaknessesissue of reimbursement for the

are otherwise not evident in clinical settings

home monitoring devices and services that are provided remains critical when introducing and advocating telemonitoring as a patient-management approachThe problem of decrease in compliance represents an important aspect that needs further explorationIt is critical to understand that home telemonitoring does not necessarily work equally among all patientsLimitationsthis review the heterogeneity of the studies found in the literature makes the comparison and aggregation of findings difficult Over all most of the studies were conducted over a short period of time and involved small samples of patients which limits the generalizability of the findings especially in relation to the sustainability and effectiveness of home telemonitoring as a patient-monitoring approach

2 McCant F Mckoy G Grubber J Olsen M K Oddone E Powers B amp Bosworth H B (2009) Feasibility of blood pressure telemonitoring in patients with poor blood pressure control Journal of Telemedicine and Telecare 15 282-285

Randomized control trial (RCT)

A total of 588 veterans with a diagnosis of hypertension from the Durham VA Medical Center147 patients were randomized into the usual care arm 441 were randomized to receive one of three interventions that included home BP telemonitoringThe intervention arms were (1) a nurse-administered tailored behavioral intervention (2) a nurse-administered medication management according to a hypertension decision support system (3) a combination of 1amp2 (4) usual care

The feasibility of using home blood telemonitoring among primary care patients with poor BP control

A research assistant trained patients in the use of the telemonitoring equipment and gave instructions to take three BP readings a week on different daysThe BP monitor (AampD 767PC CareMatrix Inc) was used to transmit data via a wireless link to a home telephone line

The data were divided according to the number of alerts 0-2 vs gt 2 The percentage of intervention subjects with 0-2 vs gt2 technical alerts for baseline demographic characteristics was calculated Means and SDs were calculated for continuous variables of interest Differences in baseline characteristics between intervention subjects were calculated using a two-tailed chi-square test for categorical variables and t-tests for continuous variables Race and employment status were divided into 2 level variables (Caucasian vs non-Caucasian retired vs not retired) for the chi-square tests

The researchers expected that patients would be able to use BP telemonitoring devices successfully and thereby improve BP control decrease medication use and overall cost in comparison to using clinic measurements

During the first six months of experience in using the BP monitoring equipment 693 technical alerts were generated by 267 patients About half of these patients (112) generated more than two technical alerts Resolution of the alerts showed that 61 were caused by patient non-adherence Patient who generated gt2 technical alerts were younger (61 vs 64 years p=0001) and were more likely to be non-Caucasian (64 vs 47 p=0002) than those generating 2 or fewer alerts

Strengthswas successful in getting 75 of the patients to use the devices correctlyWeaknessespatients will require more support to use the equipment successfully For some patients this technology may not be appropriate or is problematic patients may be either non-adherent or unable to fulfill the intervention protocol The study team should be prepared for changes in the telephone system and device infrastructure and have alternative data collection methods available The increased time and attention required by the non-adherent patients or those unable to manage the technology may have significant cost implicationsLimitationsparticipants came from a pool of veterans who received their primary health care through the Durham VA primary care clinics

3 Bosworth H B Powers B J

Randomized control trial (RCT)

591 individuals were randomized to either

Interventions that use home BP telemonitoring

The primary outcome of the

For the primary analysis a logistic

Home BP telemonitoring

Of the 591 study patients

Strengthsthose individuals with

Olsen M K McCant F Grubber J Smith V Gentry P W Rose C Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-1180

usual care or 1 of 3 telephone-based intervention groups (1) nurse-administered behavioral management (2) nurse-and physician-administered medication management or (3) a combination of both (4) usual care 49 were African American The study was conducted at the primary care clinics at a Veteran Affairs Medical Center

linked with patient feedback and medication titration may enhance access and improve outcomes for adults with hypertension

study was BP control measured at baseline and at 6 12 and 18 months using a standardized research protocol At each measurement point a research assistant masked to intervention arms asked patients to rest for 5 minutes before obtaining 2 BP measurements using a digital sphygmomanometer

mixed-effects regression model was used to estimate differences in BP control at each post baseline time point for each of the intervention groups relative to usual care Marginalized estimates and corresponding confidence intervals for the proportion in BP control for the usual care and each intervention group at 6 12 and 18 months were calculated to estimate the relative improvement in proportion of patients with BP control For secondary analyses the intervention group effects on mean systolic and diastolic BPs over time were examined Longitudinal data analysis models with an unstructured covariance was utilized to account

may improve the quality of decision making and provide the ongoing surveillance required for timely interventions for poor BP control

48 were AA 92 were male and 59 of participants had their BP under control at baseline using standardized measurements Both the behavioral management and medication management alone showed significant improvement at 12 months-128 (95 CI 16-241) and 125 (95 CI 13-236) respectively-but not at 18 months In subgroups analyses among those with poor baseline BP control systolic BP decreased in the combined intervention group by 148mmHg (95 CI -218 to-78mmHg) at 12 months and 80 mmHg

poor baseline BP control the combined intervention significantly decreased systolic BP and diastolic BP at 12 and 18 monthsWeaknessesof the interventions alone was approximately $ 1100 per patient over 18 months Each intervention demonstrated improvements in BP control or systolic BP at 12 months none of these improvements were sustained at 18 months and did not result in lower medical care costsLimitationsthat the study participantrsquos blood pressures were lower than anticipated at baseline may have hampered the ability to detect larger improvements in the BP control in the overall analyses

for the correlation of patientsrsquo repeated measurements over time Mean differences between each intervention group and the usual care group at 612 and 18 months were calculated along with corresponding 95 CI using SAS ESTIMATE statements

(95 CI -155 to -05 mmHg) at 18 months relative to usual care

4 Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-based monitoring on blood pressure control in urban African Americans A pilot study Heart and Lung Journal 30(3) 191-9

Randomized Control Trial (RCT)

Subject were recruited from a family community center on the east side of Detroit The sample contained 26African Americans with a mean age of 59 years

This pilot study compared 2 experimental interventions- home TM plus usual care or community ndash based monitoring plus usual care-with usual care only

Participants had their BP measured and completed an investigator-developed demographic profile and HTN history formBPs were measured by using an electronic BP monitor (model A ampD UA 767PC) that has been validated and is accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards

Both experimental groups yield positive results with SBP and DBP dropped significantly during the 3-months intervention period (p=03p=04 respectively) In home TM group the decrease in SBPDBP was 1488+- 138mm Hg902+- 579 mm Hg at baseline to the 3-monthsrsquo follow up level of 1241+-1382mm Hg7558+- 114In the community-based monitoring group SBP dropped from baseline level of 15525+-

The purpose of this pilot study was to test the following hypothesis Persons who participate in nurse-managed home TM plus usual care or who participate in nurse-managed community-based monitoring (CBM) plus usual care will have greater improvement in blood pressure from baseline to 3 months follow-up than will persons who receive usual care only

Both the HT group and the CBM group had clinically and statistically significant (P lt05) drops in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3 months follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 +- 138 DBP 902 +- 579 3 months follow-up SBP 1241 +- 1382 DBP

Strengthsdetermined that the cost of TM is about $150 per day which includes the cost of all equipment shipping the monitor directly to the personrsquos home telephone training and unlimited toll-free tele-transmission of the data If BP control can be achieved in a person with HTN and diabetes the incidence of extremely costly sequelae such as end-stage renal disease and heart failure can be reduced It is likely that the reduction in end-organ damage will far outweigh the cost of TM but testing of this assumption is required In addition

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

HYPERTENSION 24

Appendix B

Table 1 ndash Evaluation Table of the Level of Evidence

Citation amp study Designmethodie meta-analyses or meta-synthesis from Cochrane database

SampleSetting Major variables studied

Measurement or instruments ie observation or psychometric tools or scales

Data analysis ie Confidence interval = briefly discuss)

Researchers or authorsrsquo expected or anticipated outcomes

Findings or results

Appraisal Worth to practiceS=strengths versus W=weaknesses or L=limitations of the study

1 Jaana M Pare G amp Sicotte C (2007) Hypertension home telemonitoring Current evidence and recommendations for future studies Disease Management and Health Outcomes 15 (1) 19-31

Meta-analysis from Cochrane database

14 studies investigating the use of home BP telemonitoring that were found in the scientific literature of which only three were randomized trials

The studies present evidence on the benefits of telemonitoring as a patient-management approach and their condition such as significant BP control better medication adherence changes in patientsrsquo lifestyle as well as their attitudes and behaviors

Comparing results of all the 14 studies

The findings of all the 14 studies were analyzed and compared

Home telemonitoring to support hypertension control by allowing fast interventions and adjustments in both treatment and medications improving patientsrsquo compliance and communication with their practitioners as well as reduce the lsquowhite coatrsquo effect(White coat effect-is defined as reproducible hypertension in the medical setting and normotension in the non-medical setting)

A meta-analysis on the monitoring of BP indicates that the control of BP is better achieved when measured at home as opposed to in clinical settings especially in cases of low medication compliance co morbidities and uncontrolled hypertension The electronic transmission of data from home BP monitoring allowed regular communication with healthcare providers and supports reliable readings that

StrengthsTelemonitoring of patients with HTN appears to be an effective patient-management approach that supports BP control assists in identifying patients with the white coat effect and as such reduces the risk of over-treatment HTN telemonitoring supports patientsrsquo empowerment and reassurance by giving them direct responsibility for continuous monitoring of the BP and by ensuring regular communication with health care providers and immediate feedback even outside office hours and in remote areasWeaknessesissue of reimbursement for the

are otherwise not evident in clinical settings

home monitoring devices and services that are provided remains critical when introducing and advocating telemonitoring as a patient-management approachThe problem of decrease in compliance represents an important aspect that needs further explorationIt is critical to understand that home telemonitoring does not necessarily work equally among all patientsLimitationsthis review the heterogeneity of the studies found in the literature makes the comparison and aggregation of findings difficult Over all most of the studies were conducted over a short period of time and involved small samples of patients which limits the generalizability of the findings especially in relation to the sustainability and effectiveness of home telemonitoring as a patient-monitoring approach

2 McCant F Mckoy G Grubber J Olsen M K Oddone E Powers B amp Bosworth H B (2009) Feasibility of blood pressure telemonitoring in patients with poor blood pressure control Journal of Telemedicine and Telecare 15 282-285

Randomized control trial (RCT)

A total of 588 veterans with a diagnosis of hypertension from the Durham VA Medical Center147 patients were randomized into the usual care arm 441 were randomized to receive one of three interventions that included home BP telemonitoringThe intervention arms were (1) a nurse-administered tailored behavioral intervention (2) a nurse-administered medication management according to a hypertension decision support system (3) a combination of 1amp2 (4) usual care

The feasibility of using home blood telemonitoring among primary care patients with poor BP control

A research assistant trained patients in the use of the telemonitoring equipment and gave instructions to take three BP readings a week on different daysThe BP monitor (AampD 767PC CareMatrix Inc) was used to transmit data via a wireless link to a home telephone line

The data were divided according to the number of alerts 0-2 vs gt 2 The percentage of intervention subjects with 0-2 vs gt2 technical alerts for baseline demographic characteristics was calculated Means and SDs were calculated for continuous variables of interest Differences in baseline characteristics between intervention subjects were calculated using a two-tailed chi-square test for categorical variables and t-tests for continuous variables Race and employment status were divided into 2 level variables (Caucasian vs non-Caucasian retired vs not retired) for the chi-square tests

The researchers expected that patients would be able to use BP telemonitoring devices successfully and thereby improve BP control decrease medication use and overall cost in comparison to using clinic measurements

During the first six months of experience in using the BP monitoring equipment 693 technical alerts were generated by 267 patients About half of these patients (112) generated more than two technical alerts Resolution of the alerts showed that 61 were caused by patient non-adherence Patient who generated gt2 technical alerts were younger (61 vs 64 years p=0001) and were more likely to be non-Caucasian (64 vs 47 p=0002) than those generating 2 or fewer alerts

Strengthswas successful in getting 75 of the patients to use the devices correctlyWeaknessespatients will require more support to use the equipment successfully For some patients this technology may not be appropriate or is problematic patients may be either non-adherent or unable to fulfill the intervention protocol The study team should be prepared for changes in the telephone system and device infrastructure and have alternative data collection methods available The increased time and attention required by the non-adherent patients or those unable to manage the technology may have significant cost implicationsLimitationsparticipants came from a pool of veterans who received their primary health care through the Durham VA primary care clinics

3 Bosworth H B Powers B J

Randomized control trial (RCT)

591 individuals were randomized to either

Interventions that use home BP telemonitoring

The primary outcome of the

For the primary analysis a logistic

Home BP telemonitoring

Of the 591 study patients

Strengthsthose individuals with

Olsen M K McCant F Grubber J Smith V Gentry P W Rose C Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-1180

usual care or 1 of 3 telephone-based intervention groups (1) nurse-administered behavioral management (2) nurse-and physician-administered medication management or (3) a combination of both (4) usual care 49 were African American The study was conducted at the primary care clinics at a Veteran Affairs Medical Center

linked with patient feedback and medication titration may enhance access and improve outcomes for adults with hypertension

study was BP control measured at baseline and at 6 12 and 18 months using a standardized research protocol At each measurement point a research assistant masked to intervention arms asked patients to rest for 5 minutes before obtaining 2 BP measurements using a digital sphygmomanometer

mixed-effects regression model was used to estimate differences in BP control at each post baseline time point for each of the intervention groups relative to usual care Marginalized estimates and corresponding confidence intervals for the proportion in BP control for the usual care and each intervention group at 6 12 and 18 months were calculated to estimate the relative improvement in proportion of patients with BP control For secondary analyses the intervention group effects on mean systolic and diastolic BPs over time were examined Longitudinal data analysis models with an unstructured covariance was utilized to account

may improve the quality of decision making and provide the ongoing surveillance required for timely interventions for poor BP control

48 were AA 92 were male and 59 of participants had their BP under control at baseline using standardized measurements Both the behavioral management and medication management alone showed significant improvement at 12 months-128 (95 CI 16-241) and 125 (95 CI 13-236) respectively-but not at 18 months In subgroups analyses among those with poor baseline BP control systolic BP decreased in the combined intervention group by 148mmHg (95 CI -218 to-78mmHg) at 12 months and 80 mmHg

poor baseline BP control the combined intervention significantly decreased systolic BP and diastolic BP at 12 and 18 monthsWeaknessesof the interventions alone was approximately $ 1100 per patient over 18 months Each intervention demonstrated improvements in BP control or systolic BP at 12 months none of these improvements were sustained at 18 months and did not result in lower medical care costsLimitationsthat the study participantrsquos blood pressures were lower than anticipated at baseline may have hampered the ability to detect larger improvements in the BP control in the overall analyses

for the correlation of patientsrsquo repeated measurements over time Mean differences between each intervention group and the usual care group at 612 and 18 months were calculated along with corresponding 95 CI using SAS ESTIMATE statements

(95 CI -155 to -05 mmHg) at 18 months relative to usual care

4 Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-based monitoring on blood pressure control in urban African Americans A pilot study Heart and Lung Journal 30(3) 191-9

Randomized Control Trial (RCT)

Subject were recruited from a family community center on the east side of Detroit The sample contained 26African Americans with a mean age of 59 years

This pilot study compared 2 experimental interventions- home TM plus usual care or community ndash based monitoring plus usual care-with usual care only

Participants had their BP measured and completed an investigator-developed demographic profile and HTN history formBPs were measured by using an electronic BP monitor (model A ampD UA 767PC) that has been validated and is accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards

Both experimental groups yield positive results with SBP and DBP dropped significantly during the 3-months intervention period (p=03p=04 respectively) In home TM group the decrease in SBPDBP was 1488+- 138mm Hg902+- 579 mm Hg at baseline to the 3-monthsrsquo follow up level of 1241+-1382mm Hg7558+- 114In the community-based monitoring group SBP dropped from baseline level of 15525+-

The purpose of this pilot study was to test the following hypothesis Persons who participate in nurse-managed home TM plus usual care or who participate in nurse-managed community-based monitoring (CBM) plus usual care will have greater improvement in blood pressure from baseline to 3 months follow-up than will persons who receive usual care only

Both the HT group and the CBM group had clinically and statistically significant (P lt05) drops in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3 months follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 +- 138 DBP 902 +- 579 3 months follow-up SBP 1241 +- 1382 DBP

Strengthsdetermined that the cost of TM is about $150 per day which includes the cost of all equipment shipping the monitor directly to the personrsquos home telephone training and unlimited toll-free tele-transmission of the data If BP control can be achieved in a person with HTN and diabetes the incidence of extremely costly sequelae such as end-stage renal disease and heart failure can be reduced It is likely that the reduction in end-organ damage will far outweigh the cost of TM but testing of this assumption is required In addition

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

are otherwise not evident in clinical settings

home monitoring devices and services that are provided remains critical when introducing and advocating telemonitoring as a patient-management approachThe problem of decrease in compliance represents an important aspect that needs further explorationIt is critical to understand that home telemonitoring does not necessarily work equally among all patientsLimitationsthis review the heterogeneity of the studies found in the literature makes the comparison and aggregation of findings difficult Over all most of the studies were conducted over a short period of time and involved small samples of patients which limits the generalizability of the findings especially in relation to the sustainability and effectiveness of home telemonitoring as a patient-monitoring approach

2 McCant F Mckoy G Grubber J Olsen M K Oddone E Powers B amp Bosworth H B (2009) Feasibility of blood pressure telemonitoring in patients with poor blood pressure control Journal of Telemedicine and Telecare 15 282-285

Randomized control trial (RCT)

A total of 588 veterans with a diagnosis of hypertension from the Durham VA Medical Center147 patients were randomized into the usual care arm 441 were randomized to receive one of three interventions that included home BP telemonitoringThe intervention arms were (1) a nurse-administered tailored behavioral intervention (2) a nurse-administered medication management according to a hypertension decision support system (3) a combination of 1amp2 (4) usual care

The feasibility of using home blood telemonitoring among primary care patients with poor BP control

A research assistant trained patients in the use of the telemonitoring equipment and gave instructions to take three BP readings a week on different daysThe BP monitor (AampD 767PC CareMatrix Inc) was used to transmit data via a wireless link to a home telephone line

The data were divided according to the number of alerts 0-2 vs gt 2 The percentage of intervention subjects with 0-2 vs gt2 technical alerts for baseline demographic characteristics was calculated Means and SDs were calculated for continuous variables of interest Differences in baseline characteristics between intervention subjects were calculated using a two-tailed chi-square test for categorical variables and t-tests for continuous variables Race and employment status were divided into 2 level variables (Caucasian vs non-Caucasian retired vs not retired) for the chi-square tests

The researchers expected that patients would be able to use BP telemonitoring devices successfully and thereby improve BP control decrease medication use and overall cost in comparison to using clinic measurements

During the first six months of experience in using the BP monitoring equipment 693 technical alerts were generated by 267 patients About half of these patients (112) generated more than two technical alerts Resolution of the alerts showed that 61 were caused by patient non-adherence Patient who generated gt2 technical alerts were younger (61 vs 64 years p=0001) and were more likely to be non-Caucasian (64 vs 47 p=0002) than those generating 2 or fewer alerts

Strengthswas successful in getting 75 of the patients to use the devices correctlyWeaknessespatients will require more support to use the equipment successfully For some patients this technology may not be appropriate or is problematic patients may be either non-adherent or unable to fulfill the intervention protocol The study team should be prepared for changes in the telephone system and device infrastructure and have alternative data collection methods available The increased time and attention required by the non-adherent patients or those unable to manage the technology may have significant cost implicationsLimitationsparticipants came from a pool of veterans who received their primary health care through the Durham VA primary care clinics

3 Bosworth H B Powers B J

Randomized control trial (RCT)

591 individuals were randomized to either

Interventions that use home BP telemonitoring

The primary outcome of the

For the primary analysis a logistic

Home BP telemonitoring

Of the 591 study patients

Strengthsthose individuals with

Olsen M K McCant F Grubber J Smith V Gentry P W Rose C Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-1180

usual care or 1 of 3 telephone-based intervention groups (1) nurse-administered behavioral management (2) nurse-and physician-administered medication management or (3) a combination of both (4) usual care 49 were African American The study was conducted at the primary care clinics at a Veteran Affairs Medical Center

linked with patient feedback and medication titration may enhance access and improve outcomes for adults with hypertension

study was BP control measured at baseline and at 6 12 and 18 months using a standardized research protocol At each measurement point a research assistant masked to intervention arms asked patients to rest for 5 minutes before obtaining 2 BP measurements using a digital sphygmomanometer

mixed-effects regression model was used to estimate differences in BP control at each post baseline time point for each of the intervention groups relative to usual care Marginalized estimates and corresponding confidence intervals for the proportion in BP control for the usual care and each intervention group at 6 12 and 18 months were calculated to estimate the relative improvement in proportion of patients with BP control For secondary analyses the intervention group effects on mean systolic and diastolic BPs over time were examined Longitudinal data analysis models with an unstructured covariance was utilized to account

may improve the quality of decision making and provide the ongoing surveillance required for timely interventions for poor BP control

48 were AA 92 were male and 59 of participants had their BP under control at baseline using standardized measurements Both the behavioral management and medication management alone showed significant improvement at 12 months-128 (95 CI 16-241) and 125 (95 CI 13-236) respectively-but not at 18 months In subgroups analyses among those with poor baseline BP control systolic BP decreased in the combined intervention group by 148mmHg (95 CI -218 to-78mmHg) at 12 months and 80 mmHg

poor baseline BP control the combined intervention significantly decreased systolic BP and diastolic BP at 12 and 18 monthsWeaknessesof the interventions alone was approximately $ 1100 per patient over 18 months Each intervention demonstrated improvements in BP control or systolic BP at 12 months none of these improvements were sustained at 18 months and did not result in lower medical care costsLimitationsthat the study participantrsquos blood pressures were lower than anticipated at baseline may have hampered the ability to detect larger improvements in the BP control in the overall analyses

for the correlation of patientsrsquo repeated measurements over time Mean differences between each intervention group and the usual care group at 612 and 18 months were calculated along with corresponding 95 CI using SAS ESTIMATE statements

(95 CI -155 to -05 mmHg) at 18 months relative to usual care

4 Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-based monitoring on blood pressure control in urban African Americans A pilot study Heart and Lung Journal 30(3) 191-9

Randomized Control Trial (RCT)

Subject were recruited from a family community center on the east side of Detroit The sample contained 26African Americans with a mean age of 59 years

This pilot study compared 2 experimental interventions- home TM plus usual care or community ndash based monitoring plus usual care-with usual care only

Participants had their BP measured and completed an investigator-developed demographic profile and HTN history formBPs were measured by using an electronic BP monitor (model A ampD UA 767PC) that has been validated and is accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards

Both experimental groups yield positive results with SBP and DBP dropped significantly during the 3-months intervention period (p=03p=04 respectively) In home TM group the decrease in SBPDBP was 1488+- 138mm Hg902+- 579 mm Hg at baseline to the 3-monthsrsquo follow up level of 1241+-1382mm Hg7558+- 114In the community-based monitoring group SBP dropped from baseline level of 15525+-

The purpose of this pilot study was to test the following hypothesis Persons who participate in nurse-managed home TM plus usual care or who participate in nurse-managed community-based monitoring (CBM) plus usual care will have greater improvement in blood pressure from baseline to 3 months follow-up than will persons who receive usual care only

Both the HT group and the CBM group had clinically and statistically significant (P lt05) drops in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3 months follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 +- 138 DBP 902 +- 579 3 months follow-up SBP 1241 +- 1382 DBP

Strengthsdetermined that the cost of TM is about $150 per day which includes the cost of all equipment shipping the monitor directly to the personrsquos home telephone training and unlimited toll-free tele-transmission of the data If BP control can be achieved in a person with HTN and diabetes the incidence of extremely costly sequelae such as end-stage renal disease and heart failure can be reduced It is likely that the reduction in end-organ damage will far outweigh the cost of TM but testing of this assumption is required In addition

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

2 McCant F Mckoy G Grubber J Olsen M K Oddone E Powers B amp Bosworth H B (2009) Feasibility of blood pressure telemonitoring in patients with poor blood pressure control Journal of Telemedicine and Telecare 15 282-285

Randomized control trial (RCT)

A total of 588 veterans with a diagnosis of hypertension from the Durham VA Medical Center147 patients were randomized into the usual care arm 441 were randomized to receive one of three interventions that included home BP telemonitoringThe intervention arms were (1) a nurse-administered tailored behavioral intervention (2) a nurse-administered medication management according to a hypertension decision support system (3) a combination of 1amp2 (4) usual care

The feasibility of using home blood telemonitoring among primary care patients with poor BP control

A research assistant trained patients in the use of the telemonitoring equipment and gave instructions to take three BP readings a week on different daysThe BP monitor (AampD 767PC CareMatrix Inc) was used to transmit data via a wireless link to a home telephone line

The data were divided according to the number of alerts 0-2 vs gt 2 The percentage of intervention subjects with 0-2 vs gt2 technical alerts for baseline demographic characteristics was calculated Means and SDs were calculated for continuous variables of interest Differences in baseline characteristics between intervention subjects were calculated using a two-tailed chi-square test for categorical variables and t-tests for continuous variables Race and employment status were divided into 2 level variables (Caucasian vs non-Caucasian retired vs not retired) for the chi-square tests

The researchers expected that patients would be able to use BP telemonitoring devices successfully and thereby improve BP control decrease medication use and overall cost in comparison to using clinic measurements

During the first six months of experience in using the BP monitoring equipment 693 technical alerts were generated by 267 patients About half of these patients (112) generated more than two technical alerts Resolution of the alerts showed that 61 were caused by patient non-adherence Patient who generated gt2 technical alerts were younger (61 vs 64 years p=0001) and were more likely to be non-Caucasian (64 vs 47 p=0002) than those generating 2 or fewer alerts

Strengthswas successful in getting 75 of the patients to use the devices correctlyWeaknessespatients will require more support to use the equipment successfully For some patients this technology may not be appropriate or is problematic patients may be either non-adherent or unable to fulfill the intervention protocol The study team should be prepared for changes in the telephone system and device infrastructure and have alternative data collection methods available The increased time and attention required by the non-adherent patients or those unable to manage the technology may have significant cost implicationsLimitationsparticipants came from a pool of veterans who received their primary health care through the Durham VA primary care clinics

3 Bosworth H B Powers B J

Randomized control trial (RCT)

591 individuals were randomized to either

Interventions that use home BP telemonitoring

The primary outcome of the

For the primary analysis a logistic

Home BP telemonitoring

Of the 591 study patients

Strengthsthose individuals with

Olsen M K McCant F Grubber J Smith V Gentry P W Rose C Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-1180

usual care or 1 of 3 telephone-based intervention groups (1) nurse-administered behavioral management (2) nurse-and physician-administered medication management or (3) a combination of both (4) usual care 49 were African American The study was conducted at the primary care clinics at a Veteran Affairs Medical Center

linked with patient feedback and medication titration may enhance access and improve outcomes for adults with hypertension

study was BP control measured at baseline and at 6 12 and 18 months using a standardized research protocol At each measurement point a research assistant masked to intervention arms asked patients to rest for 5 minutes before obtaining 2 BP measurements using a digital sphygmomanometer

mixed-effects regression model was used to estimate differences in BP control at each post baseline time point for each of the intervention groups relative to usual care Marginalized estimates and corresponding confidence intervals for the proportion in BP control for the usual care and each intervention group at 6 12 and 18 months were calculated to estimate the relative improvement in proportion of patients with BP control For secondary analyses the intervention group effects on mean systolic and diastolic BPs over time were examined Longitudinal data analysis models with an unstructured covariance was utilized to account

may improve the quality of decision making and provide the ongoing surveillance required for timely interventions for poor BP control

48 were AA 92 were male and 59 of participants had their BP under control at baseline using standardized measurements Both the behavioral management and medication management alone showed significant improvement at 12 months-128 (95 CI 16-241) and 125 (95 CI 13-236) respectively-but not at 18 months In subgroups analyses among those with poor baseline BP control systolic BP decreased in the combined intervention group by 148mmHg (95 CI -218 to-78mmHg) at 12 months and 80 mmHg

poor baseline BP control the combined intervention significantly decreased systolic BP and diastolic BP at 12 and 18 monthsWeaknessesof the interventions alone was approximately $ 1100 per patient over 18 months Each intervention demonstrated improvements in BP control or systolic BP at 12 months none of these improvements were sustained at 18 months and did not result in lower medical care costsLimitationsthat the study participantrsquos blood pressures were lower than anticipated at baseline may have hampered the ability to detect larger improvements in the BP control in the overall analyses

for the correlation of patientsrsquo repeated measurements over time Mean differences between each intervention group and the usual care group at 612 and 18 months were calculated along with corresponding 95 CI using SAS ESTIMATE statements

(95 CI -155 to -05 mmHg) at 18 months relative to usual care

4 Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-based monitoring on blood pressure control in urban African Americans A pilot study Heart and Lung Journal 30(3) 191-9

Randomized Control Trial (RCT)

Subject were recruited from a family community center on the east side of Detroit The sample contained 26African Americans with a mean age of 59 years

This pilot study compared 2 experimental interventions- home TM plus usual care or community ndash based monitoring plus usual care-with usual care only

Participants had their BP measured and completed an investigator-developed demographic profile and HTN history formBPs were measured by using an electronic BP monitor (model A ampD UA 767PC) that has been validated and is accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards

Both experimental groups yield positive results with SBP and DBP dropped significantly during the 3-months intervention period (p=03p=04 respectively) In home TM group the decrease in SBPDBP was 1488+- 138mm Hg902+- 579 mm Hg at baseline to the 3-monthsrsquo follow up level of 1241+-1382mm Hg7558+- 114In the community-based monitoring group SBP dropped from baseline level of 15525+-

The purpose of this pilot study was to test the following hypothesis Persons who participate in nurse-managed home TM plus usual care or who participate in nurse-managed community-based monitoring (CBM) plus usual care will have greater improvement in blood pressure from baseline to 3 months follow-up than will persons who receive usual care only

Both the HT group and the CBM group had clinically and statistically significant (P lt05) drops in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3 months follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 +- 138 DBP 902 +- 579 3 months follow-up SBP 1241 +- 1382 DBP

Strengthsdetermined that the cost of TM is about $150 per day which includes the cost of all equipment shipping the monitor directly to the personrsquos home telephone training and unlimited toll-free tele-transmission of the data If BP control can be achieved in a person with HTN and diabetes the incidence of extremely costly sequelae such as end-stage renal disease and heart failure can be reduced It is likely that the reduction in end-organ damage will far outweigh the cost of TM but testing of this assumption is required In addition

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

Olsen M K McCant F Grubber J Smith V Gentry P W Rose C Houtven C V Wang V Goldstein MK amp Oddone E Z (2011) Home blood pressure management and improved blood pressure control Archives of Internal Medicine 171(13) 1173-1180

usual care or 1 of 3 telephone-based intervention groups (1) nurse-administered behavioral management (2) nurse-and physician-administered medication management or (3) a combination of both (4) usual care 49 were African American The study was conducted at the primary care clinics at a Veteran Affairs Medical Center

linked with patient feedback and medication titration may enhance access and improve outcomes for adults with hypertension

study was BP control measured at baseline and at 6 12 and 18 months using a standardized research protocol At each measurement point a research assistant masked to intervention arms asked patients to rest for 5 minutes before obtaining 2 BP measurements using a digital sphygmomanometer

mixed-effects regression model was used to estimate differences in BP control at each post baseline time point for each of the intervention groups relative to usual care Marginalized estimates and corresponding confidence intervals for the proportion in BP control for the usual care and each intervention group at 6 12 and 18 months were calculated to estimate the relative improvement in proportion of patients with BP control For secondary analyses the intervention group effects on mean systolic and diastolic BPs over time were examined Longitudinal data analysis models with an unstructured covariance was utilized to account

may improve the quality of decision making and provide the ongoing surveillance required for timely interventions for poor BP control

48 were AA 92 were male and 59 of participants had their BP under control at baseline using standardized measurements Both the behavioral management and medication management alone showed significant improvement at 12 months-128 (95 CI 16-241) and 125 (95 CI 13-236) respectively-but not at 18 months In subgroups analyses among those with poor baseline BP control systolic BP decreased in the combined intervention group by 148mmHg (95 CI -218 to-78mmHg) at 12 months and 80 mmHg

poor baseline BP control the combined intervention significantly decreased systolic BP and diastolic BP at 12 and 18 monthsWeaknessesof the interventions alone was approximately $ 1100 per patient over 18 months Each intervention demonstrated improvements in BP control or systolic BP at 12 months none of these improvements were sustained at 18 months and did not result in lower medical care costsLimitationsthat the study participantrsquos blood pressures were lower than anticipated at baseline may have hampered the ability to detect larger improvements in the BP control in the overall analyses

for the correlation of patientsrsquo repeated measurements over time Mean differences between each intervention group and the usual care group at 612 and 18 months were calculated along with corresponding 95 CI using SAS ESTIMATE statements

(95 CI -155 to -05 mmHg) at 18 months relative to usual care

4 Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-based monitoring on blood pressure control in urban African Americans A pilot study Heart and Lung Journal 30(3) 191-9

Randomized Control Trial (RCT)

Subject were recruited from a family community center on the east side of Detroit The sample contained 26African Americans with a mean age of 59 years

This pilot study compared 2 experimental interventions- home TM plus usual care or community ndash based monitoring plus usual care-with usual care only

Participants had their BP measured and completed an investigator-developed demographic profile and HTN history formBPs were measured by using an electronic BP monitor (model A ampD UA 767PC) that has been validated and is accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards

Both experimental groups yield positive results with SBP and DBP dropped significantly during the 3-months intervention period (p=03p=04 respectively) In home TM group the decrease in SBPDBP was 1488+- 138mm Hg902+- 579 mm Hg at baseline to the 3-monthsrsquo follow up level of 1241+-1382mm Hg7558+- 114In the community-based monitoring group SBP dropped from baseline level of 15525+-

The purpose of this pilot study was to test the following hypothesis Persons who participate in nurse-managed home TM plus usual care or who participate in nurse-managed community-based monitoring (CBM) plus usual care will have greater improvement in blood pressure from baseline to 3 months follow-up than will persons who receive usual care only

Both the HT group and the CBM group had clinically and statistically significant (P lt05) drops in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3 months follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 +- 138 DBP 902 +- 579 3 months follow-up SBP 1241 +- 1382 DBP

Strengthsdetermined that the cost of TM is about $150 per day which includes the cost of all equipment shipping the monitor directly to the personrsquos home telephone training and unlimited toll-free tele-transmission of the data If BP control can be achieved in a person with HTN and diabetes the incidence of extremely costly sequelae such as end-stage renal disease and heart failure can be reduced It is likely that the reduction in end-organ damage will far outweigh the cost of TM but testing of this assumption is required In addition

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

for the correlation of patientsrsquo repeated measurements over time Mean differences between each intervention group and the usual care group at 612 and 18 months were calculated along with corresponding 95 CI using SAS ESTIMATE statements

(95 CI -155 to -05 mmHg) at 18 months relative to usual care

4 Artinian N Washington O and Templin T (2001) Effects of home tele-monitoring (TM) and community-based monitoring on blood pressure control in urban African Americans A pilot study Heart and Lung Journal 30(3) 191-9

Randomized Control Trial (RCT)

Subject were recruited from a family community center on the east side of Detroit The sample contained 26African Americans with a mean age of 59 years

This pilot study compared 2 experimental interventions- home TM plus usual care or community ndash based monitoring plus usual care-with usual care only

Participants had their BP measured and completed an investigator-developed demographic profile and HTN history formBPs were measured by using an electronic BP monitor (model A ampD UA 767PC) that has been validated and is accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards

Both experimental groups yield positive results with SBP and DBP dropped significantly during the 3-months intervention period (p=03p=04 respectively) In home TM group the decrease in SBPDBP was 1488+- 138mm Hg902+- 579 mm Hg at baseline to the 3-monthsrsquo follow up level of 1241+-1382mm Hg7558+- 114In the community-based monitoring group SBP dropped from baseline level of 15525+-

The purpose of this pilot study was to test the following hypothesis Persons who participate in nurse-managed home TM plus usual care or who participate in nurse-managed community-based monitoring (CBM) plus usual care will have greater improvement in blood pressure from baseline to 3 months follow-up than will persons who receive usual care only

Both the HT group and the CBM group had clinically and statistically significant (P lt05) drops in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3 months follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 +- 138 DBP 902 +- 579 3 months follow-up SBP 1241 +- 1382 DBP

Strengthsdetermined that the cost of TM is about $150 per day which includes the cost of all equipment shipping the monitor directly to the personrsquos home telephone training and unlimited toll-free tele-transmission of the data If BP control can be achieved in a person with HTN and diabetes the incidence of extremely costly sequelae such as end-stage renal disease and heart failure can be reduced It is likely that the reduction in end-organ damage will far outweigh the cost of TM but testing of this assumption is required In addition

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

17014mm Hg to 1423+-121 and DBP dropped from 8942+-1095 to 7825+-686 In the usual care group BPs were unchanged withLarge effect sizes were found (f=059 and 053) for SBP and DBP respectivelyDespite the small sample size the results indicated that participants in the home TM and community-based monitoring groups had clinically and statistically significant reductions in both SBP and DBP during the 3 month monitoring period compared to the participants in the usual care group

7558 +- 114 CBM baseline SBP 15525 +- 17014 DBP 8942 +- 1095 3 months follow-up SBP 1423 +- 121 DBP 7825 +- 686) There was little change in SBP or DBP at 3 months follow-up in the usual care only group CONCLUSION These are important pilot results which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension

TM has the ability to identify patients with white-coat HTN thereby avoiding excess treatmentWeaknesseswe know that there may be advantages to home BP TM there is a need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention It is important to determine how much the intervention helped participants make BP monitoring and lifestyle modification a routine part of their daily livesLimitationscommunity- based approaches to monitoring BP hold promise as a means of facilitating access to care and obtaining control of HTN More research is needed

5 Brennan T Spettell C Villagra V OfiliE McMahill-Walraven

Randomized Control Trial (RCT)

A prospective randomized controlled study (March 2006mdashDecember 2007) was

1 BP The main dependent variable was the proportion of subjects in each group

1Two BP measurements were requested from the

After adjusting for differences between the groups at time of

It was hypothesized that a greater proportion of

This study demonstrated that home BP monitoring

Strengthssuccess of the currentprogram likely lies in the combination of BP

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

C J Lowy E hellip Mayberry R (2010) Disease management to promote blood pressure control among African Americans Population Health Management Journal 13(2) 65-72

conducted with 12 months of follow-up on each subject A total of 5932 health plan members were randomly selected from the population ofself-identified African Americans age 23 and older in health maintenance organization plans with hypertension954 accepted 638 completed initial assessment and 485 completed follow-up assessment

with BPlt120=80 the optimal levelrecommended by JNC 7 and ISHIB hypertension managementguidelinesFrequency of BP Monitoring The frequency of BP monitoringwas collected at initial and final assessments2 Frequency of BP Monitoring The frequency of BP monitoring was collected at initial and final assessments3 Number of anti-hypertension medication classes4 Health care utilization Health care utilization

participant at the start and end of the initial assessment telephone call and the final assessment call The lowest systolic and diastolic readings reported during a call were used in the analyses consistent with Healthcare EffectivenessData and Information Set (HEDIS_) guidelines for multiple BP measurements on a single visit2 Using the following question lsquolsquoAbout how often do you or your family member or friend take your blood pressurersquorsquo The frequency of BP monitoring categories were collapsed intolsquolsquoweekly or morersquorsquo and lsquolsquoless than weeklyrsquorsquo monitoring3 The proportion of members taking 2 or more anti- hypertension

initial assessment the intervention group was 46 more likely to report monitoring BP at least weekly in comparison to the control group (odds ratio [OR] 14695 confidence Interval [CI] 107-200 P=002) The intervention group was 50 more likely to have BP in compliance at final assessment than the control group (OR= 150 95 CI 0997-227 P=0052) and showed improvement in BP readings that approached the level of statistical significance established for the study

interventiongroup participants would have BPlt120=80 thancontrol group participants at the end of the 12-month studyIt was also hypothesized that intervention group participantswould have lower mean systolic and diastolic pressureswould monitor their BP more frequently and would be morelikely to use 2 or more antihypertensive medications thancontrol group participants

coupledwith a DM program that employs nurses who receivedcultural competence training as well as culturally sensitivematerials can improve BP compliance and reduce systolic BP more than a home BP monitoring device alone While a 31-point decrease in systolic BP may seem small the ALLHATstudy estimated that a 3-point change in systolic BP could explain a 10ndash20 difference in the risk of major cardiovascular events While mean systolic and diastolic BPs were lower for bothgroups

monitoring in the home and a thoughtful culturally sensitive DM program The improvement in BP control should be generalizable to African American members with health insurance who will participate or interact with their health planrsquos DM program

Weaknessesgreater prevalence of both hypertension and uncontrolled HTN in the AA community and with effective hypertension treatments available it is imperative that the health care community identify effective methods to engage AAs in programs to improve their hypertension control More participants were neededLimitationsof this randomized clinical trial include the potential for self-selection bias among participants as evidenced by a low recruitment rate compared to the number of invited individuals This underscores a

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

medication classes was measured in 2 ways First information was collected from the participant during the initial and post-telephonic assessments using a questionnaire The second method used pharmacy claims for participants who were with the health planrsquos pharmacy plan during the study period4 Health care utilization data were obtained from the health planrsquos claims system

compared to initial assessment the systolic BP adjustedmean of the intervention group was significantlylower than that of the control group (1236 vs 1267 Pfrac14003)post intervention

common problem with large- scale DM programs and is not unique to this study

6 Hill M (2003) Hypertension care and control in underserved urban African American men behavioral and psychological outcomes at 36 months American Journal of Hypertension 16 906-913

Randomized Control Trial (RCT)

The study population included 309 hypertension AAs men between the ages of 21 and 54 years and residing in inner city Baltimore

The study evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician (NPCHWMD) team and a less intensive education and referral intervention in controlling blood

TrainedOPD-GCRC personnel blinded to group assignment obtained three BP measurements at 1-min intervals with aHawksley random zero sphygmomanometerA trained

The only confidence interval (CI) reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111

This randomized clinical trial compared the effect of a lessintensive intervention to a more intensive intervention to improve HTN in AAs

At 36 months the mean SBPDBP change from baseline was -75-101 mm Hg for less intensive group (p=001 and 005 for between-group differences in SBP and DBP respectively)

Strengthof BP to meet new national goals for high-risk patients is a daunting challenge one that will require a redesign of the traditional delivery ofHTN care as well as stronger lifestyle and pharmacologicinterventions As demonstrated in this trial and in previous

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

pressure (BP) and minimizing progression of left ventricular hypertrophy (LVH) and renal insufficiency Changes in BP left ventricular mass (LVM) and serum creatinine from baseline to 36 months were compared between groups

sonographer performed transthoracic echocardiographyThe two-dimensional 56 areandashlength method was usedbecause of its potential for generating greater accuracy andreproducibility than M-mode methodsSerum creatinine total cholesterol and HDL cholesterol(in milligrams per deciliter) were measured by standardprocedures through Quest LaboratoriesDiabetes wasdefined as physician diagnosis of diabetes or serum glucose _200 mgdLIllicit drug use was determined byurine drug screen The staff interviewed participants aboutsocio-

p=11) The proportion of men with controlled BP (lt 14090 mm Hg) was 44 in the more intensive group and 31 in the less intensive group (p=045) The LVM was significantly lower in the more intensive group than in the less intensive group (more intensive 274 g less intensive 311 g p=004) There was a trend toward slowing of the progression of renal insufficiency (incidence of 50 increase in serum creatinine) in more intensive group compared to the less intensive group (more intensive 52 less intensive 80 p=08) The only

studies a multidisciplinary team approach that crossessettings and communicates with patients between officevisits has been shown to increase control ratesWeaknessesHowever we suggest that since this study hasbeen conducted successfully in the East Baltimore communityone of the most impoverished urban environmentsin the US it could be replicated in more advantageouscommunities yielding similar or even better outcomesLimitationssingle-site study with relativelysmall sample size we believe that the findings have importantclinical implications for improving HTN care andcontrol in urban under-served African American men

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

demographic and behavioral risk factors using itemsfrom the National Health Interview Survey and Hill-BoneCompliance Scale Health care utilization was assessed by asking participants whether they currently had ahealth care provider for HTN and whether they were onantihypertensive medications

confidence interval reported was in the change in creatinine serum The relative hazard ratio associated with assignment to more intensive versus less intensive was 063 (hazard ratio 95 CI=036-111 p=11)

7 Allen JKDennison-HimmelfarbCR Szanton SL Bone L Hill MN Levine DM West M Barlow A Lewis-Boyer L Donnelly-Strozzo M Curtis C amp Anderson K (2011)

Randomized Control Trial (RCT)

A total of 525 patient from urban community health centers with documented cardiovascular disease type 2 diabetes hypercholesterolemiaor hypertension and levels of LDL cholesterol blood pressure or HbA1c that exceeded goals established bynational guidelines were randomly assigned to NPCHW (n_261) or EUC (n_264) groups

Randomizedcontrolled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure glycated hemoglobin (HbA1c) and patient

The primary outcomes were changes from baseline to one year in lipids BP HbA1c and patientsrsquo perceptions of the quality of theirchronic illness care The primary outcomes also were operationalizedas meeting the goals for secondary

The data analysis for this report was generated using SAS version92 for Windows Statistical tests were used to study differences in baseline demographic clinical and risk factor characteristics with at test used for continuous variables and a x 2

Evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reductiondelivered by nurse practitioner community health worker (NPCHW) teams versus enhanced usual care (EUC) to improve lipids blood pressure

At 12 months patients in the intervention group hadsignificantly greater overall improvement in total cholesterolLDL-C triglycerides systolic and diastolic BP HbA1c andperceptions of the quality of their chronic

StrengthsAn intervention delivered by an NPCHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnesscare in high-risk patientsWeaknessesAdoption and

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

Community Outreach and Cardiovascular Health (COACH) Trial A Randomized Controlled Trial of Nurse PractitionerCommunity Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers Circulation Cardiovascular Quality amp Outcomes 4(6) 595-602

perceptions of the quality of their chronicillness care in patients in urban community health centers

prevention or experiencing aclinically significant change as follows HbA1c _7 or clinicallysignificant decrease of _05 systolic BP _140 mm Hg or_130 mm Hg if patient had diabetes or kidney disease or clinicallysignificant decrease of _10 mm Hg and LDL-C _100 mgdL or _130 if no CVD or diabetes or a clinically significant decrease of_20 The chemistry laboratory at Johns Hopkins performed allbiochemical measures Total cholesterol triglycerides and high-densitylipoprotein cholesterol (HDL-C) were measured directlyafter a 12-hour fast LDL-C was estimated using the Friedewald

test for categoricalvariables Similar statistical tests were used to compare baselinecharacteristics for subjects completing the study to those lost to follow-up for any reasonGeneralized linear mixed models using a random patient-levelintercept model were used to build multilevel models comparing theeffectiveness of the NPCHW intervention with EUC on eachoutcome controlling for the covariates of age sex race body massindex and insurance status which were determined by univariateanalyses to be predictive of outcomes Mixed models are the optimalstatistical method to use with pre-intervention and post interventionrepeated-

glycated hemoglobin (HbA1c) and patient perceptions of the quality of their chronicillness care in patients in urban community health centers

illness care comparedwith patients receiving EUCAt the 12-monthfollow-up a significantly higher percentage of patients in theintervention group compared with the EUC group had valuesthat reached guideline goals or showed clinically significantimprovements in LDL-C (EUC =58 I = 75 P lt 0001)systolic BP (EUC = 74 I = 82 P = 0018) and HbA1c(EUC = 47 I = 60 P= 0016)

sustainability of this model of care will requirefinancing mechanisms for CHWs Funding reimbursementand payment policies for CHWs must be established to ensurethat CHW models are adopted in mainstream health careLimitationsThe limitations of the COACH Trial include the fact that it was conducted in one federally qualified community healthsystem and used highly trained NPs and CHWs which maylimit generalizability Second the recruitment and screeningprocess resulted in the inclusion of a sample of predominatelyblack women However this represents the majority ofpatients seen in these and other similar community healthclinics which increases confidence in the generalizability offindings to similar settings Third physicians had

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

equation31 In the event of triglyceride levels _400 mgdL directmeasurement of LDL-C through ultracentrifugation methods wasperformed In participants with diabetes HbA1c was measured usinghigh-pressure liquid chromatography BP was measured using theOmron Digital Blood Pressure Monitor HEM-907XL automatic BPdevice according to JNC VII guidelines after 5 minutes of quiet restin the right arm with the person seated in a chair with arm supportedat heart level The average of 3 BPs was recordedThe patientrsquos ratings of care received from their health care team

measures data as this modeling approach accounts for thecorrelated data structure

patients inboth the intervention and EUC groups This may haveresulted in a change in the level of care provided to theirpatients in the EUC group as they received laboratory reportsat baseline and tended to become more vigilant with theassessment treatment and follow-up for cardiovascular risk factor management This may explain the improvements in clinical measures in the EUC group Nevertheless improvementsin clinical outcomes and perceptions of the quality ofcare were significantly greater among patients in the interventiongroup compared with the EUC group Finally there was a higher attrition rate in the intervention group (13) ascompared with the EUC group (9) However the study waspowered to account for a dropout rate of 25

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

was measured by the Patient Assessment of Chronic Illness Care(PACIC) Survey a 20-item patient report instrument that assessespatientrsquos perceptions of the receipt of clinical services and actionsconsistent with quality care defined by the Chronic Care Model32The 5 subscales are Patient Activation Delivery SystemDecisionSupport Goal Setting Problem-solvingContextual Counseling andFollow-upCoordinationSecondary outcomes included the lifestyle behaviors of dietaryintake measured by the Habits and History Food Frequency QuestionnaireBlock 200513334 and physical activity

The slightlydifferential dropout rate in the intervention group may be due to the increased commitment to participate in the interventiongroup including more visits to the clinic resulting in more costs to the participant

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

was evaluated withthe Stanford 7-Day Physical Activity Recall3536 Quality of life was measured by the 5-item EuroQol questionnaire37 and resourceutilization and patientsrsquo health care utilization data werecollected to conduct a cost effectiveness analysis which will be reported separately

8 Hacihasanoğlu R amp Goumlzuumlm S (2011) The effect of patient education and home monitoring on medication compliance hypertension management healthy lifestyle behaviors and bmi in a primary health care setting Journal Of Clinical Nursing 20(56) 692-705

Randomized Control Trial (RCT)

This study conducted in Turkey used a study group comprised of 120 subjects (40 Group A 40 Group B 40 controls)all previously diagnosed with hypertension and who started medication therapy at least one year prior to start of study The studywas conducted between FebruaryndashNovember 2006 at public primary health care facilities and homes of the study participants

The aim of this study was to determine the effect of anti-hypertensive patient-oriented education and in-home monitoringfor medication adherence and management of hypertension in a primary care setting by providing education on healthy lifestylebehaviors and medication adherence

Pretest data were collected through the administration of a descriptive questionnaire medication adherence self-efficacyscale (MASES) health-promoting lifestyle profile (HPLP) to130 hypertensive patients in the 1st 2nd and 3rd primaryhealth care facilities of Erzincan province and from personaldata (blood

Data were analyzed using SPSS statistics software version110 for Windows To treat analysis minimum and maximumvalues were controlled before the evaluation of thedata Chi-square and variance analysis (ANOVA) were usedfor the assessment of the experimental groups and thecontrol group paired t-test was used for intra-

Our hypotheses were as follows (1) Education in medicationadherence and healthy lifestyle behaviors will improvemedication adherence in the study groups (Groups A and B)(2) Education in medication adherence and healthy lifestylebehaviors will result in lower average blood pressure valuesin study groups

When the effectiveness of interventions in the both controland intervention groups was compared using the SBP DBPMASES it was found out that the both interventions wereeffective but combined education (Group B) more effectivethan

StrengthsTo the authorsrsquo knowledge this study is the first nursingintervention study to improve both medication adherence andhealthy lifestyle behaviors for hypertensive patients inTurkey In this study we shed light on professional educatorroles of the nurse Our results indicate the importance ofreceiving nursing intervention for controlled blood pressure

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

pressure height weight available in the subjectsrsquo medical records)Final data were collected through re-administration ofthe pretest questionnaires and scales blood pressure measurementsand weight measurement All data were obtainedby face-to-face interview The entire education interventionwas comprised of six interviews two during a home visitand four at the primary care facilities A sphygmomanometer (ERKA) wasused for the measurement Systolic (SBP) and diastolic bloodpressures (DBP) were recorded based on Korotkoff soundsHeight measurement was obtained using a tape

groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP variance analysis was used for inter-groupassessment of significance of the difference between theaverage pretestndashposttest scores of MASES HPLP BMI andSBP-DBP Tukey test was used for advanced analysis andMcNemar test was used for assessment of significance ofthe difference between the pretestndashposttest levels ofregular and irregular using of medications in experimentalgroups and the control group Internal consistencies of theMASES and HPLP

(Groups A and B)(3) Medication adherencelevels in study Group B (education in both medicationadherence and healthy lifestyle behaviors) will be higherthan that of the patients in group A (who receive only medication adherence education)(4) The average bloodpressures of patients in study Group B who have receivededucation for both medication adherence and healthy lifestylebehaviors will be better than the patients in study group Awho have received only medication adherence education

medication adherence education alone (Group A) onblood pressure MASES scores of interventiongroups were significantly increased Significant differenceswere noted when comparing HPLP average scores between the two study groups and between study groups and thecontrol groups (p lt 0001) For BMI no difference wasfound between the study groups A and B nor between GroupA and the control group (p gt 005) however significantdifferences were observed between Group B and the controlgroup (p lt

healthy lifestyle behaviors and medication adherence self efficacy Our results can be applicable to primary carefacilities worldwide because uncontrolled blood pressurenon-adherence medications and unhealthy lifestyle behaviorsare global problemsThe present studyshowed that a six-month education program taught by theinvestigator who is a nurse along with in-home monitoringhad a significant impact on blood pressure control Thisfinding supports the literature and verifies our secondhypothesisWeaknessesIndividual patient education haspositive effects on hypertension however we advise forfuture studies that group education may be more appropriatein some settings because it saves time and is more cost effectiveLimitations

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

measurewith the patient standing on a horizontal surface with thehead shoulder hip and heel touching a vertical wall Valueswere recorded in centimetres (cm) Weight measurement wasobtained using a standard scales with patients wearinglightweight clothes Values were recorded in kilograms (kg)Body weight (kg)height (m)2 was calculated as BMI accordingto the WHO standards

scales were tested using Cronbachrsquosalpha reliability coefficients A significance level of p = 005was used for all comparisons

005) The most significant reduction in systolic and diastolicblood pressure was seen in the intervention Group B

In this study standardization of physical measurementtools was not compared by an accredited institution Use ofother robust tools for end might be considered as animportant limitation for this study

9 9 Schwarz K Mion L Hudock D amp Litman G (2008) Telemonitoring of heart failure patients and their caregivers a pilot randomized controlled trial Progress In Cardiovascular Nursing 23(1) 18-26

Randomized Control Trial (RCT)

This pilot study was conducted ata 537-bed tertiary teaching hospitalin Northeastern Ohio Potential participants for the study included patientcaregiver dyads who met the following criteria and routinelyused the participating hospital The patients aged 65 years or olderhad a diagnosis of New

Thepurpose of this pilot study was to examine whether telemonitoring by an advancedpractice nurse reduced subsequent hospital readmissions emergency departmentvisits costs and risk of hospital readmission for patients with HF

Days to readmissiondefined as the number of days betweenthe date of initial hospital discharge andthe first readmission to the hospitalwas assessed through medical record

Descriptive and comparative analyseswere performed using SPSS forwindows version 13 (SPSS Inc Chicago IL) Descriptive statisticsfrequencies and measures of centraltendency and

The researchhypotheses were as follows(1) Hospital readmissionsED visits and costs of carewill be significantly lower for HFpatients with EHM as comparedwith usual care

There was no difference in hospitalreadmission between the intervention(n=12) and usual care (n=13) groups(c2=027 P=60) Hospital chargesalone did not

StrengthsWe found no significant health care consumption or psychological benefitto patients by adding telemonitoringin the health serviceWeaknessesThe overall lack of effect of ourintervention might be related to severalissues including the

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

York Heart Association (NYHA) classification IIIII or IV HF and were functionally impaired in at least 1 activity of dailyliving (ADL) or one instrumentalactivity of daily living (IADL) necessitatingassistance of a family caregiverThey received home care from the participating home care agency if itwas ordered by their physician had Medicare eligibility and an operating telephone line and were able tospeak English Classic symptoms of clinical HF are shortness of breath and fatigue and abnormalities of systolicand diastolic dysfunction may coexistThe principal investigator (PI) validated the diagnosis of systolic andor diastolic HF with chart review ofthe cardiologistrsquos impressions relatedto signs and symptoms of HF ejectionfraction andor the echocardiographyreport after gaining oral consent from

review after 90 daysrsquo post dischargePhysiologic health indicators bloodpressure apical pulse weight and oxygensaturation were assessed by thePI or research RN at baseline and 3months later Co morbidities and prescribedmedications were abstractedfrom the medical record before hospitaldischarge and were confirmed atbaseline Use of home health care wasdocumented with a computerized chartreview after 90 daysrsquo post dischargeSeverity of HF was assessed subjectivelyby the PI or research RN using theNYHA functional class at baselineand at 90 daysrsquo post dischargeFunctional status

dispersion were usedto describe the sample Associationsbetween variables were analyzed withPearson correlation coefficients forinterval variables and the Spearmancorrelation coefficient for ordinalvariables Means were substituted forthe relatively few areas of missing dataThe effectiveness of the interventionwas examined by using an intention to treat analysis a was set at ge05Outcomes were examined between the2 groups using chi-squared likelihoodratio tests for categorical variablest tests for approximately normallydistributed variables and Wilcoxonrank sum tests for skewed variables

(2) Rates of depressivesymptoms will be lower but days toreadmission and measures of qualityof life and caregiver mastery will be significantly higher in the EHMgroup compared with usual care(3) Caregiver masteryinformal social support and EHMwill significantly reduce the risk ofhospital readmission for patientswith HF

differ significantlybetween intervention and usual caregroups ($1099686$2923005$546258$982500 respectivelyP=26) In addition out-of-pocketcosts for medications physician officevisits and laboratory testing weresimilar between groupsWhiledifferences existed between groups at baseline with regard to caregivermastery there were no differencesbetween groups for any outcome atthe 90-day follow-up visit Cox proportional hazards regression

experience of the current cohort of older adults and thenature of their illness Baby boomersare more experienced with technologyand they may desire more sophisticatedmeans of monitoring their health as they ageLimitationsOur study has several limitations Ourfindings are limited to patients classifiedin NYHA classes II III and IV Since31 of patients in this study wereNYHA class IV a replication studyusing less severely ill patients may leadto greater differences between groupseven with a short follow-up periodAlthough the majority of interventionpatients reported that they used theEHM system on a regular basis the PIdid not have information about whetherteaching before hospital discharge wasconsistent between groupsFunctional status

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

the patient before hospital discharge Overall 562 patientswere screened for eligibility (Figure)Of these 152 (27) were eligible 102(67) agreed to participate

was measuredas the ability to perform ADLs andIADLs at baseline and 90 daysrsquo post dischargeThe ADL tool27 consistsof 6 items (eating dressing bathingtransfers incontinence and toileting)and is scored from 0 (totally independent)to 2 (totally dependent)Depressive symptomatology was measured using the Center forEpidemiological Studies DepressionScale (CES-D) at baseline and 90daysrsquo post discharge Participants rated20 items on a 4-point Likert scalefrom 0 (ldquorarelyrdquo) to 3 (ldquomost or all ofthe timerdquo) with a possible range of 0to 60 Higher scores indicate more depressive

Subgroup analyses were conductedcomparing the intervention and usualcare groups by risk status Survival analysis with Cox proportionalhazard modeling was used toassess risk for hospital readmission bythe number of days between dischargeand first readmission Cox proportionalhazard modeling accommodates for the censoring of information and accountsfor the competing risk The pool ofpotential predictors of risk for hospitalreadmission specific to the dyad includedcaregiver mastery informal socialsupport and EHM The multivariablemodel was derived using multiplemodel building techniques backwardelimination with

modeling was used to identifyindependent predictors of riskfor hospital readmission in daysIndependent variables includedcaregiver mastery informal socialsupport and telemonitoring (yesno) None of these predicted risk ofhospital readmission

number ofco morbidities and medication usedid not differ significantly betweengroups at baseline or 90 daysrsquo post dischargePatients subjectively reportedtheir functional abilities however andseverity of co morbidities was not studiedIn past studies of patients withHF researchers reported variations inhow medications were prescribed andissues with compliance3940 Althoughpatients reported taking medicationsas prescribed a formalized monitoringsystem was not used Informationabout dosages or changes in medicationswas not collected and thesevariables could have differed betweengroups and affected resultsSpecific number of visits to thepatientsrsquo cardiologistprimary

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

symptomsQuality of life defined as patientrsquosperceptions of the effects of HF ononersquos life was measured with 18 items from the Minnesota Living with HFquestionnaire (MLWHF) at baselineand 90 daysrsquo post discharge TheMLWHF measures individualsrsquo perceptionsof the ways in which symptomsof HF have impacted their lives in the past month Since the majority of patients were older and not employedand depression was assessed with theCES-D questions about workingsexual activities and depression were eliminated from the original scale Eighteen items were rated on a 6-point Likert scale from 0

a=05 stay criteriastepwise with a=25 enter criteria anda=05 stay criteria to identify independentpredictors of days to readmission

physicianand how physicians respondedto nursing assessments were also notobtained as part of the study Several ofthe cardiologists voiced concerns aboutthe amount of paperwork involvedwhen monitoring via an EHM system Lack of attention to paperwork couldhave minimized information used indecision making and therefore limitedactions that could have prevented hospitalizationor early readmissionLimitations of the study may bedue to absence of control over usualcare provided by the home care agencyContrary to this study others useda study nurse to provide care andtogether the PI and nurse reviewedassessments of patients20 Finally therewas no group that received EHM andnot home care in our study Thus we

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

(ldquonordquo) to 5 (ldquoverymuchrdquo) with a possible range of 0to 90 A higher score indicated more symptomatic impact on onersquos lifeCaregiver mastery defined as apositive view of onersquos ability to provide care was measured with the masterysubscale from the PhiladelphiaGeriatric Center Care giving AppraisalScale (PGCCAS) at baseline and 90daysrsquo post discharge Six items assess the likelihood of caregiver uncertaintyabout how to provide care reassurancethat the patient is receiving propercare feeling on whether they shouldbe doing more for the patient feeling

do not know whether EHM wouldbenefit patients who have a similarstatus as a solo resourceservice

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

that they are doing a good jobof providing care perceptions aboutcapability of dealing with problems asthey arise and identifying the patientrsquosneeds Caregivers rated 6 items on a5-point Likert scale from 1 (ldquoneverrdquo)to 5 (ldquonearly alwaysrdquo) with a possiblerange of 6 to 30 Higher scores indicatedgreater mastery Informal social support describedas instrumental activities performedby families and friends was measuredwith the tangible subscale fromthe Modified Inventory of SociallySupportive Behaviors Scale (MISSB)36at baseline The tangible subscalereflects activities

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

such as receiving amonetary loan Caregivers rated 9items on a 4-point Likert scale from1 (ldquoneverrdquo) to 4 (ldquovery oftenrdquo) witha possible sum score of 9 to 36Higher scores indicated more informalsocial supportCost of care was calculated for the90-day period postndashinitial hospitalizationCharges post hospitalizationwere calculated by tracking billingcharges for rehospitalization emergencydepartment visits and chargesfor usual home care from the providerof home health care

10Artinian NT Flack

JMNordstrom CK

HockmanEM Washington OGM Jen KC amp Fathy M (2007)

Randomized Control Trial (RCT)

Subjects were recruited from a family community center on the east side of Detroit Participants were conveniently selected from the community center The primary

Persons who participate in nurse-managed home telemonitoring (HT) plus usual care or who participate in nurse-man- aged community-based monitoring (CBM) plus

BPs were measured by using an electronic BP monitor (model AampD UA 767PC) that has been validated and is

A 100 compliance rate meant that all BPs (a total of 60) were measured in the 10-week interval between baseline at week 1 and

Providing easy access to BP monitoring can inform persons that their BP is elevated and will remind them of the need to take

Both the HT group and the CBM group had clinically and statistically significant (P lt 05) drops in systolic blood

StrengthsRandomization and high compliance rateWeaknessessample sizeLimitationsfindings from this research raise another

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans Nursing Research 56(5) 312-322 doi10109701NNR0000289501452846e

goal of screening was to identify otherwise healthy African American men and women with HTN Criteria for inclusion were an age ge18 years and an SBP ge140 mm Hg or a DBP ge90 mm Hg unless the person self-identified as having diabetes or claimed a history of a heart attack in which case an SBP ge130 mm Hg or a DBP ge85 mm Hg were acceptable Principal exclusion criteria included the following receiving hemodialysis having been diagnosed with dementia or another mental illness defined as not being oriented to time person or place having compliance risk (ie self-identified heroin cocaine or other illicit drug user) being home- less or having other major health problems such as the terminal stages of cancer or advanced liver disease The sample contained 26 African Americans with a mean age of 59 years

usual care will have greater improvement in blood pressure from baseline to 3 monthsrsquo follow-up than will persons who receive usual care only

accurate to within plusmn3 mm Hg or 5 and falls within the Advancement of Medical Instrument standards20 BPs were measured after a 5-minute rest period 2 BPs were measured 5 minutes apart and the average of the 2 was used for analyses Participants wore unrestrictive clothing and sat next to the investigatorrsquos desk with their feet on the floor their back supported and their arm abducted slightly flexed and supported at heart level by the smooth firm surface of the desk

follow-up at week 12 There was a mean 67 compliance rate (SD 0233) in the telemonitoring group and a mean 89 compliance rate (SD 0082) in the community group (t10 = ndash223 P = 06) The significance level was set at 005

action Taking action can mean complying with recommended lifestyle changes and when necessary implementing an antihypertensive drug regimen By offering telemonitoring to patients these goals can be achieved

pressure (SBP) and diastolic blood pressure (DBP) at 3 monthsrsquo follow-up with participants in the HT group demonstrating the greatest improvement (HT baseline SBP 1488 plusmn 138 DBP 902 plusmn 579 3 monthsrsquo follow-up SBP 1241 plusmn 1382 DBP 7558 plusmn 114 CBM baseline SBP 15525 plusmn 17014 DBP 8942 plusmn 1095 3 monthsrsquo follow-up SBP 1423 plusmn 121 DBP 7825 plusmn 686) There was little change in SBP or DBP at 3 monthsrsquo follow-up in the usual care only group

important question why did the intervention work We do not know the mechanisms by which telemonitoring works to lower BP and achieve BP control

11McManus RJ Mant J Bray EP Holder

Randomized Control Trial (RCT)

Patients were eligible for enrolment if they were aged 35ndash85 years

Control of blood pressure is a key component of

Patients assigned to the intervention group were

After 12 months 166 (71) of 234 patients in the

Self-management of hypertension in combination with

527 participants were randomly

Strengths Randomization Large sample size high

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

R Jones MI Greenfield S Kaambwa B Bryan S Little P Williams B amp Hobbs FD (2010) Telemonitoring and self-management in the control of hypertension (TASMINH2) a randomized controlled trial Lancet 376(9736) 163-172 doi101016S0140-6736(10)60964-6

receiving treatment for hypertension with two or fewer antihypertensive drugs had a blood pressure at baseline of more than 14090 mm Hg and were willing to monitor their own blood pressure and self-titrate medication The age range for eligibility had been increased from 35ndash75 years to 35ndash85 years after 3 months when it became apparent that older patients were able to undertake the trial procedures and there were concerns about recruitment Exclusion criteria were blood pressure more than 200100 mm Hg postural hypotension (gt20 mm Hg systolic drop) terminal disease dementia score of more than ten on the short orientation memory concentration test14 hypertension not managed by their family doctor or spouse already randomized to study group This randomized controlled trial was undertaken in 24 general practices in the UK

cardiovascular disease prevention but is difficult to achieve and until recently has been the sole preserve of health professionals This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care

invited to two training sessions run by the research team Participants were trained to monitor their own blood pressure for the first week of each month with a validated automated sphygmomanometer (Omron 705IT Omron Healthcare Europe Hoofddorp Netherlands) and to transmit blood pressure readings to the research team by means of an automated modem device (i-modem Netmedical De Meern Netherlands) which was connected to the sphygmomanometer and plugged into a normal telephone socket like an answerphone17 Two self-measurements were made each morning with a 5-min interval and the second

intervention group ranked self-monitoring as their preferred method of blood pressure monitoring compared with 103 (43) of 242 in the control group (plt0middot0001) Confidence Interval was set at 95

telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care

assigned to self-management (n=263) or control (n=264) of whom 480 (91 self-management n=234 control n=246) were included in the primary analysis Mean systolic blood pressure decreased by 12middot9 mm Hg (95 CI 10middot4ndash15middot5) from baseline to 6 months in the self-management group and by 9middot2 mm Hg (6middot7ndash11middot8) in the control group (difference between groups 3middot7 mm Hg 0middot8ndash6middot6 p=0middot013) From baseline to 12 months systolic blood pressure decreased by 17middot6 mm Hg (14middot9ndash20middot3) in the self-management

compliance rateWeaknessesa need for more research because we do not know the effects of this strategy on long-term control of BP The next phase of research needs to monitor the effects of the intervention for a longer period and allow for a gradual reduction in the intensity of the intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

reading acted upon A color traffic light system was used by participants to code these readings as green (below target but above safety limit) amber (above target but below safety limits) and red (outside of safety limits) A month was deemed to be ldquoabove targetrdquo if the readings on 4 or more days were above target

group and by 12middot2 mm Hg (9middot5ndash14middot9) in the control group (difference between groups 5middot4 mm Hg 2middot4ndash8middot5 p=0middot0004) Frequency of most side-effects did not differ between groups apart from leg swelling (self-management 74 patients [32] control 55 patients [22] p=0middot022)

12 Parati G Omboni S Albini F Piantoni L Giuliano A Revera M Illyes M amp Mancia G (2009) Home blood pressure telemonitoring improves hypertension control in general practice The TeleBPCare study Journal of Hypertension 27(1) 198-203 doi101097HJH0b013e3283163caf

Randomized Control Trial (RCT)

a minimum number of 288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Three hundred and ninety-one hypertensive patients consecutively seen in the GPsrsquo offices were screened for inclusion in the study Inclusion criteria were an age between 18 and 75 years a diagnosis of uncontrolled essential hypertension as

Self blood pressure monitoring at home may improve blood pressure control and patientsrsquo compliance with treatment but its implementation in daily practice faces difficulties Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring

All patients were subjected to at least five office visits at screening (visit one) at randomization (visit two after 1 week) and during follow-up (visits three to five after 4 12 and 24 weeks respectively) At inclusion the patientrsquos history was taken combined with a

288 patients were required to guarantee a power of 80 and a minimum level of significance of 005 Out of these 329 patients 288 patients in whom all data were available at the end of the study were included in the intention-to-treat analysis Data analysis was carried out by the SPSS for Windows

Self home blood pressure monitoring (HBPM) has a number of potential advantages in the management of hypertension [1] These advantages include avoidance of the lsquowhite-coat effectrsquo availability of multiple BP readings over a wide time window

Baseline office blood pressures were 149 W 12 89W9 and 148W1389W7mmHg in groups A (nU111) and B (n U 187) respectively the corresponding daytime values being 140 W 1184 W 8 and 139 W 1184 W 8 mmHg The

Strengthswas determined by ABP monitoring which provides BP values devoid of inconveniences such as the white-coat effect the advantage of combining self-measurement of BP at home with data teletransmission is supported by two additional findings

Weaknessesdesign prevented a comparison with the

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

defined by the occurrence of an office SBP of at least 140 mmHg or DBP of at least 90 mmHg and by an ambulatory mean daytime SBP of at least 130 mmHg or DBP of at least 80 mmHg (regardless of whether patients were or were not treated) Exclusion criteria were a diagnosis of secondary hyper- tension major systemic diseases atrial fibrillation or frequent cardiac arrhythmias or severe atrioventricular block that is conditions that could make HBPM and ABP measurements unreliable obesity (BMI gt30 kgm2) or an arm circumference of more than 32 cm or both to avoid inaccuracies in automated BP readings due to armndash cuff mismatch and any condition that might prevent patientsrsquo participation in the study for example technical problems due to incompatible phone lines at home

physical examination and two BP measurements at a 5 min interval using the validated oscillometric device that had to be used for HBPM (Tensiophone device Tensiomed Budapest Hungary) The software of this device was validated according to the International Protocol recommended by the European Society of Hypertension Working Group on BP monitoring [11] The device is equipped with a built-in modem permanently plugged to the house phone line and subjected to remote programming of the frequency of measurements as well as of the time of a telereminding beep which can be sent to the

software version 115 (SPSS Inc Chicago Illinois USA) Quantitative variables were described through the calculation of average 1113088 SD values for each dataset Discrete variables were described by their absolute and relative frequency of occurrence Between-group differences were assessed by analysis of variance for continuous variables and by the chi-squared test of MantzelndashHaenszel for discrete variables The between-group comparison of the percentage of patients with normalized ABP was made by chi- squared test Throughout the study the level of statistical significance was set at a P value of less than 005

evaluation of the effects of treatment on BP at different times of the day and improvement in patientsrsquo adherence to therapy

percentage of daytime blood pressure normalization was higher in group B (62) than in group A (50)

(P lt 005) There were less frequent treatment changes in

control group Limitations design adopted does not allow us to discriminate the role played by HBPM per se and by HBPM combined with teletransmission facilities in obtaining a greater rate of BP control

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

patient to stimulate adherence to measurement schedule whenever appropriate Self-monitored BP values were regularly transmitted to a referral centre where data were checked and stored in a digital database Values exceeding upper and lower predefined arbitrary safety thresholds (180110 and 10060 mmHg respectively) triggered an alarm on the basis of which a dedicated trained nurse called the patient at home to check hisher clinical status and the possibility of artefactual measurements

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

HYPERTENSION 51

Appendix C

Table3

Levels and Types of Evidence

Levels and Types of Evidence 1 2 3 4 5 6 7 8 9 10 11 12Level 1Meta-analysis or meta-syntheses from Cochrane Review (Highest)

X

Level 2RCT with randomization X X X X X X X X X X X

Level 3RCT without randomization

Level 4Case control or cohort study

Level 5Systematic review of qualitative or descriptive study

Level 6Single or individual qualitative or descriptive study Clinical practice guidelines

Level 7Expert opinion or state of the science report (Lowest)

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

HYPERTENSION 52

Appendix DTable 4

Level of Evidence (Quality Score)

Study Level Quality Score Design1-6

1=best1-3

1=bestLxQ

Study 1 1 1 1 Meta-analysis

Study 2 2 1 2 RCT

Study 3 2 1 2 RCT

Study 4 2 1 2 RCT

Study 5 2 1 2 RCT

Study 6 2 1 2 RCT

Study 7 2 1 2 RCT

Study 8 2 1 2 RCT

Study 9 2 1 2 RCT

Study 10 2 1 2 RCT

Study 11 2 1 2 RCT

Study 12 2 1 2 RCT

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

HYPERTENSION 53

Appendix ETable 5

GANTT chart

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

HYPERTENSION 54

Appendix F

Budget for EBPCP Implementation

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention

HYPERTENSION 55

Appendix G

Interview Sample Questions for Patientsrsquo Satisfaction Evaluation

Open-ended questions

1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN

adhering to the BP medications BP monitoring increasing physical activity diet control smoking

cessation and decreasing alcohol consumption

2) How satisfied are you with the proposed educational intervention incorporating home tele-

monitoring by APNs

3) What additional information would you want us to include in this educational intervention