1. Pre Viva Presentation for CRP Study 2009
Data Presentation
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2. A Health Related Quality of Life Study in Patients with Acute Coronary Syndrome: The Cost-Effectiveness of Clinical Pharmacy Service in the Phase I, and Short Course Phase II Cardiac Rehabilitation Program
Mr. Lawrence AnakAnchah,700713-13-5325(Principal Investigator)
Research Area: (FCA 701/ 48), Cardiovascular Pharmacy
Reference No under NIH KKM:MRG-2007-11
Main Supervisor:
Professor Dr. Mohamed Izham Bin Mohamed Ibrahim
Field Supervisor and Co-Principal Investigator:
Professor Dr. SimKuiHianMBBS(Hons)(Monash), FRACP, FACC, FCSANZ , FSCAI, FESC, FAPSIC, FAsCC, FCAPSC, FAHA, FAMM, FNHAM,Head, Dept of Cardiology & Head, Clinical Research Centre (CRC), Sarawak General Hospital, MALAYSIA.
Adjunct Professor, Faculty of Medicine & Health Sciences, University Malaysia Sarawak (UNIMAS)
Co-Supervisor:
1. Dr. MohdAzmi Ahmad Hassali
2. Prof. Dr. Yahaya Hassan
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3. Introduction
Cardiac rehabilitation programs (CRP) has a different level of models and structures.
Pharmacy Perspective: Phase I, in-patient CRP, and the outpatient phase II of CRP has poorly described in many articles elsewhere.
The role of clinical pharmacy services in cardiology in Malaysia has been extensively evaluated since 2003.
However, pharmacists involvement assemble in the interdisciplinary teamwork in the out-patient phase II CRP.
Those services contain the intervention entity of counselling.
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4. Aims & Design of Cardiac Rehabilitation
Programs designed to limit physiologic and psychological effects of cardiac illness, risk for sudden death or reinfarction, control cardiac symptoms, stabilize or reverse atherosclerotic process, & enhance psychosocial and vocational needs of selected patients(USDHHS, 1995).
CR services comprehensive, long-term programs involving 1)medical evaluation, 2)prescribed exercise, 3)cardiac risk factor modification, 4)education and counseling
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5. Significant of this study : Economic, Clinical and Humanistic Outcomes (ECHO), measurement of disease and therapeutic outcomes
In this new model of CRP, will it be the most cost-effective or worthwhile effort for the administrators to implement the new role of clinical pharmacy service in cardiac rehabilitation?
What is the major impact of outcomes that will be established from this collaborative practice and interdisciplinary teamwork by each health care provider in the phase I and short-course phase II CRP?
Clinical OutcomesHospitalization, FLP improvement, BP, FBS, MACE reduction
ECHO (Economic Clinical Humanistic Oucomes)ICR
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6. OBJECTIVES OF STUDY
General Objective
To determine the QoL outcomes in post ACS patients with interventional MCRP versus with the conventional CCRP
To evaluate the impact of the clinical pharmacy collaboration practice in CRP in term of clinical outcomes and health-related outcomes.
Specific Objectives
To assess the cost effectiveness of the intervention relativeto other secondary prevention care programmes, effectivenesssuch as life years gained from the health care service perspective with the application of cost utility analysis approach.
To investigate adherence to treatments.
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7. Outline of CRP
Phase I
Inpatients
Stage I (admission)
Stage II
Stage III (discharge)
Phase II
Outpatient
4-8 weeks program
Phase III and Phase IV
Community based or society based program
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8. General Phases in CR Provision
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Phase Iis the inpatient program that begins soon after a cardiac event (such as a heart attack, angioplasty, or a bypass surgery) and finishes when the patient is ready to go home from the hospital. The emphasis is on low-level exercise and education for the patient and family.
Phase IIis an outpatient hospital-based program that begins approximately 2 weeks after discharge from the hospital. Dietitians, social workers, pharmacists, physicians, and others may also be involved in the care. This phase emphasizes monitored exercise and continued education on exercise and lifestyle management.
Phase IIIis an ongoing community-based exercise and education program supervised by cardiac nurses and exercise specialists. Spouses and significant others may also participate in this maintenance program with a referral from a physician.
Phase IVis a continuation of Phase III but without supervision. In this phase, the patients continue to apply what they have learned during the preceding phases.
9. Phase I, Stage I CRP (First assessment)
2004 Perth Royal Hospital, WA
What we have learned from others and improve it.
Phase I CRP
Cardiac Care Unit, Sarawak General Hospital
Ward rounding
Pharmacist will identify those who needs counseling
Stage I in counselling
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10. Phase I, Stage II CRP (CTW)
Bed side counselling regarding the evidence based medication
Our target: IHD, UA, post MI, post PTCA, post CABG, HF and on warfarin
Concomitant diseases/problems therapy (hyperlipidaemia, gout, DM, HPT, peripheral vessel disease, chronic AF.)
Stenting (DES and BMS), double antiplatelets
Medication and disease
Medication adherence
Self purchase (plavix), cardiprin
RF
Smoking cessation advise
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11. Phase I, Stage IIIBed side and discharge counselling
Preparation for Rx
Screening and filling
Medication discharge sheet (name, dose, frequency, duration, side effect, important notes)
Counseling session and
documentation in BHT
CP1, 2 and 3
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12. Phase II CRP in 2003-2008
Revolutionize the practice from forum to group counseling
From common dissemination of knowledge to individualized counseling
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13. Group counseling (The ideal)
Talks in different languages
Different in knowledge/educational levels
Limitation
More than one pharmacist
Coordination with colleagues
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14. Methodology Framework of Research
METHODOLOGY AND MATERIALS
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15. Participants:
Admitted to CCU and CTW for recruitment
+112 patients aged 2570years who were self-caring, literate and able to speak English/Malay/Dayak.
Able to read or understand the Self-answered questionnaire
Kuching based locality for Cardiac rehabilitation program
Others are in control group and willing to be assessed for next 6 and 12 months follow-up
Eagle KA et al. Guideline-Based Standardized Care Is Associated With Substantially Lower Mortality in Medicare Patients With Acute Myocardial Infaction. JAAC 2005;46(7):1242-8.
Mehta RH, et al. Enhancing Quality of Care for Acute Myocardial Infarction: Shifting the Focus of Improvement From Key Indicators to Process of Care and Toll Use: J Am CollCardiol 2004; 43:2166-73.
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16. Sample size
In the study by Azman AB et al. on Malaysian general population using the SF-36, we derived the standard deviation from VT domains as = 17.68 and we wish to estimate the true mean to within 5 points with 95% confidence.
Naing NN et al. 2003 guideline of estimation of sample size we derived;
= 17.68, = 5, and z = 1.96
n= (z /) 2
=(1.96 X 17.68/ 5 ) 2
=48.03

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17. The criteria for inclusion and exclusion
For CRP phase 2 ( 4 weeks)
Post MI (ACS, NSTEMI, STEMI)
PCI ( BMS, DES)
CardiothoracicBypass
Will be longer in cardiac clinic for review and follow-up
EXCLUSION
Over 70 years old
LVEF < 40%, high risk
?? compliance
Other comorbidities- Aneurysm, ESRF, acute renal disease not resolve
Logistic issue to follow-up, address?? Phone number???
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18. Pre-post nonequivalent groups quasi-experiment.
not a randomized experiment
Experimental design with multiple groups and multiple waves of measurement; lack of control.
quasi-experimental design
"nonequivalent" because in this design we do not explicitly control the assignment and the groups were nonequivalent
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19. Screening and Recruitment process from Jan-Dec 2008
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20. Study DesignMethodology Framework of Research
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21. LOS,
Demographic Baseline
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22. LOS, days in CICU, CTW and CCU
LOS Range (1 to 37 days)
Median = 4,
n=73,
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23. Baseline during admission
Demographic Data
Mean Age from 3 groups
Common complain
Length of admission/stay
ACS stratum commonly noted
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24. 24
25. 25
26. Analysis of baseline finding
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27. Risk Factors LVSD
LVSD cover most of risk factors, majority almost 64% are having 5-6 RF,

Sedentary lifestyle

28. HPT 29. DM 30. Family 31. Smoking 32. Lipid 33. Age27
34. Risk Factor Non-LVSD
Less than 25% are having 4-5 RF
Majority 75%, 1-3 RF
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35. Cardiac Enzymes during ACS event
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36. The Prescribing Pattern for Secondary Prevention in ACS with or without Asymptomatic Left Ventricular Systolic Dysfunction
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37. Anti Remodeling Medication: extreme least
LVSD
Non LVSD
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38. LVSD group
28 patients (66.66%)
60.7% STEMI
mean EF 41.61% (S.E.M = 1.41)
60.71% (n=17) treated with concomitant therapy of renin-angiotensin-aldosterone system inhibitors (RAAS Inhibitors) and beta blockers
35.7% (n=10) not prescribed with any RAAS inhibitors prior to discharge
Non-LVSD group

14 patients (33.33%)

39. EF of mean 58.14% (S.D. = 4.46) 40. 50% (n=7) were prescribed both ACEI & beta blockers 41. 50% were neither on ACEI nor ARBsNancy M. Recognizing and Managing Asymptomatic Left Ventricular DysfunctionCrit Care Nurse 2008. 28(2): 20-37
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42. 33
43. Left Main Stenosis
Based on the COROS and NCVD database
18.7 % in the LVSD group are having more than 50 percent occlusion at the LM
However, those in NLVSD are negligible.
May explained inconsistency in prescribing, example far less ACEI prescribed in NLVSD group.
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44. Possible Finding & Discussion
Possible causes are lack of recognition of LVSD when symptoms are not present clinically or
Unwarranted fear of prescribing of vasoactive cardiovascular therapy (ACEI/ARB) to patients with LVSD in this study.
Non LVSD is marginally less prescribed with ACEIs or ARBs
Prescribing delay may due to BUSE level or due fear of hypotension with add on antihypertensive drugs.
Nancy M. Recognizing and Managing Asymptomatic Left Ventricular DysfunctionCrit Care Nurse 2008. 28(2): 20-37
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45. HR, BPS, BPD
CLINICAL FINDING
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46. FIGURE: Vital Sign: Heart Rate (hr1) noted during accident & emergency or the first reading while admittedThe control (group 3) and group 2, are mixed of those that referred to SGH and from A&E
MCRP=1,CCRP=2, Control=3
The control (group 3) and group 2, are mixed of those that referred to SGH and from A&E
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47. Vital Sign: Heart & BP after 12 months follow-up
* Man-Whitney U Test
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48. Hard End Point & Solf End Point after 12 months Follow-up
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49. Data Analysis in Cumulative Events within 12 months follow-up
All cumulative events found after 12 months follow-up was non significant different among the 3 arms
However, during the initial stage ofdata collection Hard End point for MCRP was high and found there is a significant different in both control and conventional groups.

More CABG cases were referred to the rehabilitation program due to the fact that this is a quasi experimental design. MCRP (n=8), 36.3%, p= and CCRP (n=9), 32.14%

50. In control group only 20.93% (n=13) underwent CABG but refused or unable to join the CRP; therefore this data contribute less MACE analysis. 51. A lot of drop out in control group as we found that on 46.7% (n=29) were able to be contacted. Therefore, we will uncertain issues regarding their clinical outcomes. 52. Conclusion: Cardiac rehabilitation will cost more to health care provider but to certain extent . This it is because the operational cost that provided by clinician and the urgency of postACS treatment .40
53. Lifestyle Counseling Skill among clinical Pharmacists & other health care providers
This exploration study looking into the effectiveness of MCRP interventions to promote adherence to medications and inculcate knowledge of illness-treatment.
Education Cardiac Patients & Spouse
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54. FLP baseline for 3 groups at initial stage of admission,MCRP=12, CCRP=12, CONTROL=36
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55. Pre and Post Cholesterol Finding 12 months follow-up
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56. Optimizing lipids (low-density lipoprotein-LDL) cholesterolafter 12 months follow-up.

Clinical improvement in reducing LDL level in all arms.

57. LDL reduction in MCRP of 0.709, and CCRP of 0.718, this greaterimprovement as compare with Control Group that only up to 0.298 Lauderdale, S. A (2005). Intensive Lipid-Lowering Therapy in Patients with Coronary Heart Disease. Ann Pharmacother, 39(2), 329-334.
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58. Finding:

Clinical improvement in reducing cholesterol level in all arms.

59. Highly significant different was found in Intervention group (p