quality improvement case study - usaid assist · of pih diagnosis, treatment, and management....

Q U A L I T Y

A S S U R A N C E

P R O J E C T

Center for Human Services • 7200 Wisconsin Avenue, Suite 600 • Bethesda, MD 20814-4811 • USA

Q U A L I T Y I M P R O V E M E N T C A S E S T U D Y

Developing Evidence-BasedStandards for Pregnancy-

Induced Hypertension in Russia

September 2002

The Quality Assurance (QA) Project is funded by the U.S. Agencyfor International Development (USAID), under Contract NumberHRN-C-00-96-90013. The QA Project serves countries eligiblefor USAID assistance, USAID Missions and Bureaus, and otheragencies and nongovernmental organizations that cooperate withUSAID. The QA Project team consists of the Center for HumanServices (CHS), the prime contractor; Joint CommissionInternational (JCI); Johns Hopkins University School of Hygieneand Public Health (JHSPH); Johns Hopkins University Center forCommunication Programs (JHU/CCP); and the Johns HopkinsProgram for International Education in Reproductive Health(JHPIEGO). Together, they provide comprehensive, leading-edgetechnical expertise in the design, management, and implementa-tion of quality assurance programs in developing countries. TheCenter for Human Services, the nonprofit affiliate of UniversityResearch Co., LLC, provides technical assistance in theresearch, design, management, improvement, and monitoring ofhealthcare systems and service delivery in over 30 countries.

QUALITYASSURANCE

PROJECT

TEL (301) 654-8338

FAX (301) 941-8427

www.qaproject.org

About this seriesThe Case Study series presents real applications ofQuality Assurance (QA) methodologies in developing coun-tries at various health system levels, from national to commu-nity. The series focuses on QA applications in maternal andreproductive health, child survival, and infectious diseases.Each case study focuses on a major QA activity area, such asquality design, quality improvement, the development andcommunication of standards, and quality assessment. Insome cases, more than one QA activity is presented.

Quality improvement is a systematic process of address-ing the gaps between current practices and desired stan-dards. Effective approaches to quality improvement includeindividual problem solving, rapid team problem solving,systematic team problem solving, and process improvement.These methods vary in the time and resources required andthe number of people who participate. Regardless of the rigorand intensity of the method used, quality improvementapproaches usually share four basic steps: identification of anopportunity for quality improvement, analysis of improvementarea, development of possible interventions to address aneed for improvement, and testing and implementation ofinterventions. The four-step quality improvement approachserved as the basis for the methodology for clinical guidelinedevelopment described in this case study; the methodologyhas six steps and incorporates evidence-based standards.

This case study describes how facility-level teams workedwith department of health leaders in Tver Oblast, Russia, tocreate an evidence-based guideline as part of a larger qualityimprovement project to improve the system of healthcaredelivery for women suffering from pregnancy-inducedhypertension.

AcknowledgmentsThe Department of Health of Tver Oblast, Russian Federation;the Central Public Health Research Institute of the Ministry ofHealth, Russian Federation; and the Quality Assurance Projectimplemented the work described in this case study. It waswritten by Kim Ethier and is based on interviews with RashadMassoud, Pauline Glatleider, Patrick Nugent, Anna Korotkova,Olga Chernobrovkina, Lydia Samoshkina, Tatiana Gviniashvili,and Tatiana Dmitrieva. Technical contributions and review wereprovided by Rashad Massoud. The section on the economicimpact of the project was researched and written by HanyAbdallah. Editorial review was provided by Ya-Shin Lin andDiana Silimperi.

Recommended citationEthier, K. 2001. Developing Evidence-Based Standards forPregnancy-Induced Hypertension in Russia. Quality AssuranceProject Case Study. Published for the U.S. Agency forInternational Development (USAID) by the Quality Assurance(QA) Project: Bethesda, Maryland, U.S.A.

The key organizations and people whoimplemented the work were:

Central Public Health Research Institute, Ministry ofHealth, Russian FederationAnna V. Korotkova, MD, Ph.D., Head of Methodological Center

for Quality

Tver Oblast Department of HealthAlexander N. Zlobin, DirectorLydia K. Samoshkina, MD, Head of Maternal and Child HealthTatyana F. Dmitrieva, MD, Chief NeonatologistTatyana P. Gviniashvili, MD, Chief OB/GYN

Vyshny Volochyok Maternity HospitalLyubov P. Timokhina, MD, OB/GYN Deputy Chief Physician,

Central District HospitalSerguey V. Stepanov, MD, Head of OB/GYN Department,

Maternity HospitalNatalya N. Lukashova, MD, OB/GYNDmitry G. Kalinin, MD, Head of Women’s Clinic

Torzhok Central District HospitalValeria P. Gyerassimova, MD, Head of Maternity DepartmentYury Rumyantsev, MD, OB/GYN, Delivery DepartmentLyudmila Dmitrieva, MD, Head of Women’s Consultation ClinicIrina Pavlova, MD, OB/GYN, Women’s Consultation ClinicSvetlana Kolossova, MD, OB/GYN, Women’s Consultation ClinicIrina Bobrova, MD, OB/GYN, Women’s Consultation ClinicGalina Astakhova, MD, Anesthesiologist

Tver Maternity Hospital #1Nikolay P. Zavgorodny, MD, Head of Gynecological DepartmentLyudmila V. Vinogradova, MD, Head of 1st Obstetrical

DepartmentOlga P. Korsakova, MD, Head of Women’s ClinicLyudmila N. Orlova, MD, Head of 2nd Obstetrical DepartmentYuri K. Shishkov, MD, Head of Anesthesiology DepartmentOlga V. Karpova, MD, NeonatologistVyacheslav, G. Kozlov, MD, Anesthesiologist

Evidence-Based Standards for PIH in Russia

1. Study the existing system of health care delivery(and create a flowchart depicting the system).

2. Clarify what clinical content knowledge is used foreach step in healthcare delivery.

3. Review evidence-based literature on the subjectmatter of the clinical guideline.

4. Update clinical content in accordance with theevidence-based knowledge of the subject matter.

5. Introduce changes to the system of care to enablethe implementation of updated content knowledge.

6. Review indicators to ensure that they reflectchanges in both subject matter knowledge andchanges in the system of care.

Define

Analyze

Develop

Plan

Test andImplement

Study

Act Do

Quality ImprovementMethodology

Evidence-Based Clinical GuidelineDevelopment Methodology


Background

In September 1997, theHealth Committee of theUnited States – RussianFederation Joint Commissionon Economic and TechnologicalCooperation decided to addressissues of access to quality healthcare as a priority area forcollaboration between the two countries. The United StatesAgency for International Development (USAID) was asked toprovide technical assistance in quality improvement. USAIDresponded by providing assistance through the QualityAssurance (QA) Project. In June 1998, a task force outlinedthe scope of work (SOW) for the access to quality healthcarepriority area. The SOW included two demonstration projects inmaternal child health in Tver and one in primary care in Tula.The QA Project set up demonstration projects to adapt qualityimprovement methods to Russian organizational culture inclose collaboration with Russian and U.S. organizations,including the Ministry of Health of the Russian Federation(MOH RF), the Central Public Health Research Institute(CPHRI) of the MOH RF, Tver Oblast Department of Health,the Agency for Health Research and Quality (AHRQ), and theU.S. Department of Health and Human Services.

■ 1

Developing Evidence-Based Standardsfor Pregnancy-Induced Hypertensionin Russia

Q U A L I T Y I M P R O V E M E N T C A S E S T U DY


In July 1998, a planning meeting for the demonstrationprojects was held with Tver Oblast Department of Healthofficials, including the Director of Health, the Head of Maternaland Child Health, the Head of Obstetrics/Gynecology, theHead of Neonatology, selected practicing physicians, qualityimprovement experts, a representative of CPHRI, and repre-sentatives of Tver State Medical Academy. A steering commit-tee was formed later, with many of the same people, tooversee the work of the project. One goal of the planningmeeting was to determine the maternal health problem mostin need of improvement in Tver Oblast. Pregnancy-inducedhypertension (PIH) was chosen because it was the singlelargest cause of maternal mortality in Tver Oblast, the majorcause of complications in pregnancy, and a cause of compli-cations in newborns. In 1997, cases of PIH occurred in 18.1percent of all pregnancies, and the number of severe formstotaled 4.3 percent of all pregnancies; for the first six monthsof 1998, these figures were 16.3 percent and 3.2 percent,respectively.i On average worldwide, cases of PIH (pre-eclampsia) amount to approximately 5 percent of totalpregnancies: less than one third the Tver figures.ii

PIH includes the conditions of pre-eclampsia and eclampsia. Itcan lead to maternal death and contribute to premature birthand perinatal morbidity and mortality. The diagnosis, manage-ment, and treatment of PIH were some of the most challeng-ing clinical areas in maternal and child health facing the Tver

2 ■

Tver Oblast enjoyshealthier mothersand babies as aresult of the newguideline.

Evidence-Based Standards for PIH in Russia ■ 3

Oblast Department of Health. To add to the impact of PIH onthe region, a large number of hospitalizations, the multitude ofclinical interventions for severe forms, complicated deliveries,premature births, and neonatal rehabilitation made PIH anexpensive complication in obstetrics and neonatology.

Once oblast leadership had decided on PIH as the area forimprovement, they were able to choose representativefacilities where the demonstration projects would take place.The three pilot facilities were Tver (city) Maternity Hospital #1,Vyshny Volochyok Maternity Hospital, and Torzhok CentralDistrict Hospital. These facilities were chosen based on theirwillingness to participate and represented a mix of urban andrural hospitals with a range of available resources. All threefacilities include women’s consultation clinics and deliverydepartments.

The PIH project in Tver would serve as a demonstration ofhow quality improvement (QI) methods can be broughttogether with evidence-based medicine to create changesthat result in significant improvements in the healthcaredelivery system and consequently in the health of the patients.One part of the overall QI effort was the development andimplementation of an evidence-based clinical guideline inorder to improve healthcare delivery based on a new modelof PIH diagnosis, treatment, and management.

Standards Development

Methodology for clinical guideline development. Theclinical and organizational guideline was developed as a keypart of the improvement in the quality of care for women withPIH. While this case study focuses on the guideline develop-ment and dissemination, it must be understood within thecontext of the entire QI methodology used for the QualityAssurance Project in Russia. The model for this QI project wasbased on Batalden and Stoltz’s framework for the continualimprovement of healthcare,iii which suggests the integration ofclinical content knowledge and improvement knowledge as apowerful means of continual improvement in healthcare. Themain principles of quality management were also applied in

Evidence-Based Standards for PIH in Russia4 ■

the development of the clinical guideline. These principles area systems approach, teamwork, customer focus, andscientific methodology. Based on this framework and theprinciples of quality management, Dr. Rashad Massoud of theQA Project/URC-CHS developed a six-step methodology fordeveloping clinical guidelines as an important part of improv-ing quality of care. (See Figure 1.)

Steps for developing clinical-organizational guide-lines. A unique feature of the methodology is its integration ofclinical content and the organization of care through the sixsteps listed on the right of Figure 1.

Figure 1. Diagram Comparing the QI and GuidelineDevelopment Methodologies

1. Study the existing system of health care delivery(and create a flowchart depicting the system).

2. Clarify what clinical content knowledge is used foreach step in healthcare delivery.

3. Review evidence-based literature on the subjectmatter of the clinical guideline.

4. Update clinical content in accordance with theevidence-based knowledge of the subject matter.

5. Introduce changes to the system of care to enablethe implementation of updated content knowledge.

6. Review indicators to ensure that they reflectchanges in both subject matter knowledge andchanges in the system of care.

Define

Analyze

Develop

Plan

Test andImplement

Study

Act Do

Quality ImprovementMethodology

Evidence-Based Clinical GuidelineDevelopment Methodology


Some of the steps in the guideline development methodologycan take place simultaneously because the clinical content ofcare and the organization of the healthcare system cannot beseparated. The new design of the organization of care mustallow for the implementation of new clinical knowledge.

Throughout development of the guideline, Russian and U.S.-based quality assurance experts made frequent visits to theimplementation sites to provide guidance and support in theQI process. The experts teamed with clinical content expertsfor the coaching and training process, as well as for localcapacity building.

Before starting the QI project, all team members, oblast andfacility leadership, and others responsible for implementationwere trained in quality assurance theories and methods. Teammembers and oblast and facility leadership also attendedtraining of trainers courses to learn the skills necessary toteach others the updated clinical information and QI method-ology.

1. Study the Existing System of HealthcareDeliveryTo begin the analysis of the current system of care, represen-tatives from each stage of healthcare delivery for pregnantwomen were chosen to form a team at each pilot facility. Therepresentatives would be primarily responsible for analyzingand improving the system of care. The facility-level teamsincluded senior physicians, obstetrician/gynecologists, nursesand midwives, and other professionals who were in positionsresponsible for ensuring the implementation of changes madeto clinical practice. Together these professionals provideinsights on clinical content and organization for each step inthe process of care. The team carefully reviewed and dis-cussed their understanding of the organization of the systemof care, which yielded a detailed flowchart (Figure 2) toillustrate the process of healthcare delivery as it was at thattime.


Figure 2. “Before” Flowchart of Care for Women with Pretoxemiaand Toxemia

Hospital treatment

Yes

PIH?

Hospitalization

Can bedischarged?

Requiresreferral?

Protocol for treatment ofpretoxemia

Referral forhospitalization

Protocol forhospital

treatment

Transfer

Women withpretoxemia

No

Yes

No

Yes

No

No

Women’sclinic knows?

Prophylactic ambulatorytreatment

Criteria for pretoxemia

Criteria fortoxemia

Criteria fordischarge

Delivery? Delivery

1. Work with woman and her family2. Hospital at home3. Day hospital

Criteria fortransfer

Protocol for each of above

Yes

Yes

No

Criteria fordelivery No

Yes


2. Clarify Clinical Content for Each Step inHealthcare DeliveryEach facility-level team then went back through the flowcharton the process of healthcare delivery and, for each step in theprocess, clarified the clinical content used in making diagnosesand decisions on treatment. The clinical content includedclinical definitions, criteria for diagnoses and referral, variousclinical decision-making steps, and treatment guidelines. Theclinical content information was listed in separate detailedappendices and referenced in the flowchart. This step allowedthe team members to discover discrepancies in practice,inconsistency in decision making, and technical problems. Insome cases, the process of drawing the flowchart anddiscussing the existing clinical practices led to small, butimmediate, changes and improvements. For example, onehospital recognized the need for a standard place for allexamining room equipment so that each item would be easierto find.

3. Review Evidence-Based Literature forClinical AreaDuring the analysis of the current system of care, the oblastleaders, facility head physicians, and representatives of thefacility-level teams reviewed the evidence-based literature incollaboration with Russian and U.S.-based clinical contentexperts. These individuals began to familiarize themselves withthe state-of-the-art, evidence-based medicine for managementof PIH from literature and information provided by the U.S. andRussian clinical experts. The international medical communityhas seen several significant changes in the understanding ofthe pathology and treatment of PIH over the last 40 years, andmany of these changes have not yet been disseminated widelyin Russia. Physicians and specialists in Tver, while eager tokeep up with clinical advances, had limited access to state-of-the-art clinical information, reference materials, and articles dueto problems of availability, language, and cost.

The system of healthcare in Russia requires physicians tofollow directives and methodological recommendations fromoblast health authorities and the Ministry of Health. Since the


new clinical content would require clinical practices outside ofexisting directives and methodological recommendations,facility teams could not make these decisions alone: theymade decisions in close collaboration with Russian experts inmaternal health and incorporated involvement from theMinistry of Health. This required policy dialog, reviews ofclinical evidence, and debate before an agreement could bereached. The Head of Maternal Health in the MOH RF wasespecially helpful in approving the guideline and clinicalchanges at the federal level.

Deciding on clinical content to be adopted. Russianand U.S. experts in the field of obstetrics/gynecology aidedthe oblast leaders, head physicians, and a few members ofeach facility team with the decision on new and updatedclinical content of the guideline by collecting evidence-basedliterature on PIH. The literature review for evidence-basedcontent included both international and Russian resources onPIH. International literature was translated into Russian so thatall involved in the decision-making process could review theevidence-based content. The review of clinical contentincorporated several viewpoints because there is disagree-ment among the international community on the best diagno-sis and management of PIH.

In reviewing the evidence-based literature, deciding on theclinical content, and writing the guideline, the team agreed toachieve the following:

■ To create an understanding the pathophysiology of PIH

■ To use international definitions

■ To use internationally accepted diagnostic criteria

■ To outline a treatment that was accurate (dosages,medications, frequency)

■ To avoid unnecessary treatments and procedures

■ To use a multidisciplinary approach

Teaching the new clinical content. Consultants held twoseminars to relate the current understanding of the diseaseand to update physicians on best practices. Communication


of the clinical information and discussion on updating clinicalcontent began with an initial clinical content training in January1999. A more intensive content training was held in April 1999with oblast leaders and facility team members who would beinvolved in the decision on new clinical content.

4. Update Clinical ContentOnce all oblast leaders and facility teams were familiar withthe evidence-based content, they needed to decide how tochange their clinical practice in order to make the contentcompatible with the best available evidence. They firstreviewed the up-to-date clinical content to decide whatelements were relevant to them and what was possible toimplement given the reality of their healthcare system. Thisstep was especially difficult because of the lack of internationalconsensus on the diagnosis and management of PIH. Theoblast leaders and facility team members carefully decided onthe clinical content that was supported by strong evidence,and they focused on how to implement it in local circum-stances.

After the first content seminar and throughout the process,new ideas and concepts on treatment were disseminated toteam members and physicians in Tver Oblast at facilities’weekly or monthly discussions. Facility team membersparticipating in the seminars were expected to train their fellowteam members and relevant personnel at their facilities in the

A doctor visitsa new motherand child inTarzhokMaternityHospital.


Table 1. ICD-10 Classification of Pregnancy-InducedHypertension (O13-O15)

state-of-the-art management of PIH. Within a few months, allstaff in the pilot facilities had been trained in the updatedclinical content.

Changes in clinical content. One of the first diseaseaspects updated in the new guideline was the name of theillness. Russian physicians had been using the term “toxemia,”which had been changed throughout the world to “pregnancy-induced hypertension.” The name change is a reflection in partof the change in the understanding of the disease pathology.

Part of the reason for high percentages of PIH amongpregnant women in Tver can be attributed to diagnosticcriteria, which were different than those used internationally.The criteria included a category of pre-toxemia that encom-passed any woman showing signs of lower-limb edema duringpregnancy.1 The former Russian practice of care stipulatedthat a diagnosis of pre-toxemia due to swelling warranted

O13. Pregnancy-induced hypertension without significant proteinuriaGestational hypertension NOSMild pre-eclampsia

O14. Pregnancy-induced hypertension with significant proteinuriaO14.0 Moderate pre-eclampsiaO14.1 Severe pre-eclampsiaO14.9 Pre-eclampsia, unspecified

O15. EclampsiaO15.0 Eclampsia in pregnancyO15.1 Eclampsia in laborO15.2 Eclampsia in the puerperiumO15.9 Eclampsia, unspecified as to the time period

Eclampsia NOS

NOS: Not Otherwise Specified

1 Edema is swelling, and lower-limb edema is normal in many pregnantwomen.


Table 2. ICD-10 Diagnostic Criteria for Pregnancy InducedHypertension (PIH) (O13-O15)

■ 11

hospitalization and intravenous treatment. The Russian andU.S. clinical specialist team determined that the InternationalClassification of Diseases-10 (ICD-10; see Tables 1 and 2)should be used in the PIH guideline for the purposes ofclassification and diagnostic criteria. The updated classifica-tion and diagnostic criteria changed the Russian physicians’perception of PIH.

Table 2 outlines the diagnostic criteria adapted for the ICD-10PIH classifications used in the clinical guideline. These criteriaare based on a review of the literature and synthesis of themost current clinical recommendations used in the U.S. Theyhelp to clarify not only the diagnosis of PIH, but also theseverity and risk involved for each patient.

Pregnancy-inducedhypertension withoutsignificant proteinuria(Mild pre-eclampsia(O13)

Arterial pressure > or = 140/90 mmHg but under 160/110mmHg taken at rest at least 6 hours apart or an increaseof 30 mmHg in the systolic pressure or 15 mmHg in thediastolic pressure from the baseline (baseline bloodpressure documented at < 16 weeks gestation)

Proteinuria < 0.3 gm or < 1+

Edema: No hand and facial edema

Pregnancy-inducedhypertension withsignificant proteinuria(Moderate pre-eclampsia O14.0.)

Arterial pressure > or = 140/90 mmHg but under 160/110mmHg taken at rest at least 6 hours apart or anincrease of 30 mmHg in the systolic pressure or 15 mmHg in the diastolic pressure from the baseline (baselineblood pressure documented at < 16 weeks gestation)

Proteinuria > 0.3 gm but < 5 gm a day or 1+ to 2+

Edema: Hand and/or facial edema may or may not bepresent

Pregnancy-inducedhypertension withsignificant proteinuria(Severe pre-eclampsiaO14.1)

Arterial pressure > or = 160/110 mmHg taken at rest atleast 6 hours apart

Proteinuria > or = 5 gm/24 hours or 3+ to 4+

Edema: Hand and/or facial edema may or may not bepresent


One of the most significant changes in the approach totreating PIH in Tver Oblast was the shift to mono-therapy withintravenous magnesium sulfate (IV MgSO4). In all, over 70different types of medications were being used to treat womenwith PIH before the project in Tver. Intra-muscular magnesiumsulfate was used as a prophylactic treatment for pre-eclamp-sia, but no evidence demonstrates its effectiveness. Aftermuch discussion between the team and content experts onthe evidence-based literature and the differences in manage-ment internationally, the Tver team decided to apply mono-therapy using IV MgSO4 treatment as prophylaxis for theprevention of eclampsia, the common practice in the U.S.

Introducing and implementing changes in the clinicalcontent. Implementation of these new clinical practicesinvolved complex behavior and attitude changes. Obstetrician/gynecologists were at first skeptical of the proposed methodsof treatment because it was contrary to the practices that theyhad been taught and were using. Other reasons for theircautious approach varied from the belief that what they weredoing worked well to fear of being held responsible if compli-cations arose. Once consensus was reached on a policy level,the physicians became more comfortable changing theirpractices. The numerous evidence-based articles andreference materials contributed to their confidence in tryingthese new methods.

The new clinical content was introduced gradually and testedin the pilot facilities before being made into a new guideline.After a few physicians had used the new methods, more wereencouraged to begin. A content expert followed up on theprogress of the doctors’ implementation of the new clinicalcontent knowledge in June 1999. She found that althoughmany of the new practices, such as mono-therapy using IVMgSO4, were being used, treatments and dosages were notalways given in accordance with the evidence-based informa-tion, which could have caused potentially serious and evenfatal effects. A third clinical content seminar was held immedi-ately for a small core group of physicians from Tver OblastDepartment of Health and facility teams. The training cyclewas repeated at each facility to correct and firmly incorporate

12 ■


the new practices. A later follow-up visit by a clinical contentexpert confirmed that the third conference and subsequenttrainings successfully resulted in guideline use.

5. Introduce Changes to the System of Care toEnable the Implementation of Updated ContentKnowledgeThe objective of this step is to decide how the system ofhealthcare delivery must to be changed in order to allow forthe implementation of updated clinical content. Once oblastleaders and facility team members had decided on the clinicalcontent to adopt, the teams returned to the original flowchartto decide how the system of care and current clinical prac-tices had to be changed in order to allow for the implementa-tion of new clinical content. A new flowchart was drawn toclearly define the updated system. At each clinical decisionstep, the flowchart referred to the appropriate section of ICD-10 (see Figure 5).

Changes in the system of care. The criteria for hospitaliz-ing women with PIH can serve as an example of a significantchange made in the system of care. Under the former systemof care, the majority of women diagnosed with PIH of any

severity were hospitalized for the remainder oftheir pregnancy. The new guideline recom-mends that women with mild and moderatePIH be treated on an outpatient basis throughlocal clinics. The new system also provideseducation for women on necessary behaviorand dietary changes as well as the warningsigns of progression to a more seriouscondition. One result is that midwives’ rolesand responsibilities increased in patientfollow-up and in monitoring patient condi-tions.

Writing the guideline based onchanges in clinical content andorganization of care. The guideline wasdrafted as decisions were made onchanges in clinical content and the system

Cover of the printedversion of the guideline


of care. The writing process took several months of discussionand negotiation between the facility teams, head physicians,and Russian and U.S.-based content experts. By the end,they had agreed on a guideline that was acceptable andrealizable within the Russian context, while still following state-of-the-art, evidenced-based practices. The issues that createdthe most discussion were:

14 ■

Figure 3. “After” Flowchart for the Process of Care for Womenwith PIH

Moderatepre-eclampsia

O14.0?

PIH withoutconsiderableproteinuria

O13?

Severepre-eclampsia

O14.1?

EclampsiaO14.1?

Can the patientbe discharged?

Has PIHdeveloped?

PIH symptomsmanagement

Out-patient treatmentaccording to the guideline

In-patient and out-patienttreatment according to

the guideline

In-patient treatment onlybefore delivery according

to the guideline

Treatment in placeaccording to the

guideline

Delivery Treatment in generalmedicine division

Registrationof pregnant

womanPIH rehabilitation,

planning of the nextpregnancy

Yes

Yes

Yes

Yes

No

No

No

Yes No

Yes

No


2 Various leaders—facility, oblast department of health, or Ministry of Healthofficials—in the Russian healthcare system issue prikazi (directives) regardingnew protocols and decisions or changes made to clinical, organizational, oradministrative aspects of healthcare. Directives themselves are not newprotocols or guidelines, but rather instructions to healthcare providers tobegin using them.

■ 15

■ Inclusion of treatments and therapies with no evidence-based proof of efficacy

■ Use of polypharmacy (multiple drugs)

■ Accuracy and clarity with regard to appropriate dosages,especially for MgSO4

Oblast health authorities supported changes in the clinicalpractices in the form of a “prikaz”2 (directive). The guidelinewas agreed upon, printed, and implemented. Several monthslater, another review was necessary to address oversights andclarify instructions that were revealed through clinical practice.

Official implementation of new guideline. Table 3shows the timeline for the development of the PIH guideline.By September 1999, all three demonstration sites were usingthe updated clinical content, testing parts of the new systemof care, and collecting data. By this time, staff at the sitesrecognized that the new system of care should be acceptedas their way of working. Data and improvements werepresented at a formal meeting for the official adoption of theguideline by the pilot sites. The Tver Oblast Department ofHealth signed a prikaz officially implementing the new guide-line for the pilot facilities. In addition, a conference wasconvened with approximately 75 people, including facilityadministrators, head doctors, and others involved in theimplementation process, in order to rally support and agree-ment for the program. Later in the month, the head obstetri-cian/gynecologist at the MOH RF sent a letter of review of theguideline and officially approved it for use in Tver Oblast in thethree sites. Once the federal level issued official permission, allmedical personnel involved in the project were more confidentabout following the new guideline.

Adoption of the new clinical-organizational guideline.As stated earlier, the new clinical practices were introduced


gradually throughout the improvement process. Althoughofficial implementation of the guideline occurred in September1999, many aspects of the new clinical content were alreadybeing practiced.

Interestingly, the facility that adopted these changes first wasnot the central, urban hospital with more funding, but ratherthe provincial hospital in Torzhok. Tver Maternity Hospital #1 inTver city, the last of the three pilot sites to begin using theupdated guideline, was encouraged to start once they saw thesmall town hospital in Torzhok making improvements. Despiteinitial reluctance, the teams successfully developed andimplemented the evidence-based clinical guideline in all threepilot sites.

Table 3: Timeline of Development of PIH Guideline

Significant Events

U.S./Russian Joint Commission on Economic andTechnical Cooperation Health Committee “Access toQuality Healthcare” priority area Task Force Meeting

First planning meeting and trip for QA Project staff

First QA training for leaders

Training of trainers

First large content training; training for teams in Tula,Tver, and Moscow

Organization of care workshops

2nd Content training for small group (mainly doctors)

Content experts check sites for use of new guideline;3rd Content training

Prikaz and letter from head of Maternal Health MOH RF

Results conference

Project scale-up begins

Date

June 1998

July 1998

October 1998

December 1998

January 1999

February 1999

April 1999

June 1999

September 1999

July 2000

September 2000


Revisions of the guideline. During the first year of use, itbecame clear that several sections of the guideline should berewritten or clarified. a year after the implementation, interna-tional experts and Tver specialists met to discuss necessarychanges and updates. A revised version was published inorder to ensure patient safety, the physicians’ ability tocorrectly implement the guideline, and the relevance to localcircumstances.

6. Review IndicatorsAt the start of the project, while the system of care was beingstudied, a set of indicators was designed based on the clinicalcontent used at that time in the delivery of care. Theseindicators were based on the former classification andapproach to the management of PIH. Once the new organiza-tion of the system of care was developed and new clinicalcontent was decided upon, the indicators were revised toensure that they reflected these changes and would ad-

Key Changes Made to the System of Care for Womenwith PIH in Tver

1. The new clinical guideline is based on the 10th edition of theInternational Classification of Diseases (ICD-10).

2. The new clinical guideline represents a significant change inthe understanding of PIH; it stresses the importance of mono-therapy with Mg SO4 and early delivery.

3. The new guideline does not include old categories of pre-toxemia or require preventative hospitalization or various othernon-evidence-based treatments for PIH.

4. The new guideline has promoted the role of the midwife in themanagement of PIH.

5. Existing “directives” and “methodological recommendations”are being changed in order to facilitate the implementation ofthe new system.


equately measure improvements. For example, when the firstset of indicators was created, IV Mg SO4 was not being used:a new indicator had to be added so that the use of thistreatment could be monitored.

All indicators in this project were collected in three pilot sitesand tracked through the use of run charts. Figure 4 is anexample of one indicator: It shows the delivery to women withPIH as a percentage of all deliveries in the three pilot sites. Thefirst arrow points to a drop that signals the introduction of theevidence-based clinical guideline in the demonstration project.The second drop came at the beginning of the scale-up asteam members from demonstration sites were trained astrainers for the newly participating organizations: by virtue oftheir training experience, the trainers and their organizationsbecame more proficient in the clinical content and practice,causing the drop.

ResultsClinical ResultsThe results from the Quality Assurance Project in Tver Oblast,such as those in Figure 4, show that the guideline is beingsuccessfully implemented in the three pilot facilities withpositive results. Achievements include the appropriateness of

Figure 4. Sample Run Chart of Results: Deliveries toWomen with PIH as a Percentage of All Deliveries

Jan-

98

Mar-98

May-9

8

Jul-9

8

Sep-9

8

Nov-9

8

Jan-

99

Mar-99

May-9

9

Jul-9

9

Sep-9

9

Nov-9

9

Jan-

00

Mar-00

May-0

0

Jul-0

0

Sep-0

0

Nov-0

0

Jan-

01

Mar-01

46.4

42.9

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Phase IIStart-up

Phase IChanges60

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the guideline to the local conditions, the clinical content, andthe new organization. Between the implementation of theguideline clinical content in January 1999 and May 2001,there were:

■ No cases of maternal death due to eclampsia

■ No cases of progression to eclampsia in patients managedby the new system of PIH care

■ A 77 percent reduction in the number of hospitalizationsdue to PIH

Economic Impact of the Evidence-BasedGuidelineIn parallel to the implementation of the new clinical guideline,an operations research study was conducted to measure theimpact of using new guideline on the cost of hospital care forPIH.iv The study examined the effect of the new clinicalpractices on the cost of care, including a reduction in thenumber of drugs used in treatment and reductions in thelength of hospital stays.

Figure 5. Total Cost of Care for PIH

60

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0Before After

Rub

les

in th

ousa

nds

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A before-and-after, cross-sectional study was used (sixmonths before and after the implementation of new guideline).Data were collected by reviewing medical records for allwomen who were admitted with mild, moderate, or severeforms of PIH to two hospitals in the project. (Drug costsincurred by patients were assessed for one hospital.) Basedon changes made in clinical practice in the new guideline, thecosts of drugs, hospitalizations, and clinical tests wereexpected to change.

The following is a summary of some of the findings from thestudy:

■ Overall, a cost saving of about 87 percent in the averagetotal cost of care was observed. Reductions in the numberof hospitalizations as well as in the average cost of care perpatient were important drivers of cost saving (See Figure 5).

■ Reduction in the total average cost of hospitalizationsaccounted for about 70 percent of the total cost saving.The decrease was mainly due to the drop in the number ofhospitalizations as well as shorter hospital stays (79percent drop in total patient-days or an average 13 percentdrop per patient).

■ The average total cost of care per patient decreased by 41percent, from an average of 1,080 rubles per patient to637.

Using evidence-basedmedicine has reducedboth medications andhospitalizations.

20 ■


■ The total average costs of drugs and tests also decreased,by 95 percent and 80 percent, respectively, due to the newapproach in managing and treating PIH.

■ The average cost of drugs per patient decreased by 62percent, driven largely by the reduction in the number ofdrug types used from 72 to 32.

■ Analysis of patient costs also suggests potential costsavings for the patients: up to 66 percent per patient fromdrug cost savings.

■ The number of drugs used to treat PIH dropped signifi-cantly: from 72 types to 32; Mg SO4 use increased.

The change in the cost of hospital and drug care between thebefore and after patients contributes to the indicators that thenew guideline was being followed. The findings suggest thatefforts to improve quality can be accomplished while reducingcosts. In addition, the evidence-based guideline for managingpregnancy-induced hypertension led to improved healthoutcomes for women and their newborns, suggesting thatlong-term cost benefits may result.

Phase II: Oblast-Wide Scale-up of PIHGuideline

Less than a year after implementation of the PIH guideline, theexceptional results of the quality improvement in the three pilotsites led to a decision to scale up the project to an oblast-wide level. Scale-up efforts include all women’s consultationclinics and maternity hospitals in Tver Oblast: 42 hospitals in37 regions. As of this writing, participants and trainers fromthe pilot projects are conducting most of the quality assurancetraining, clinical content training, and coaching. Teams at eachfacility are adapting the organizational aspects of the newguideline for local circumstances. Facilities and individualmedical personnel have been responsive to the project andencouraged to participate by the results from Tver, Torzhok,and Vyshny Volochyok.

■ 21


Standards Development and QualityImprovement Insights

■ The Russian experience shows that guidelinescreated by the users are more easily imple-mented in the local setting. Clinical guidelines areoften developed by experts, either from the countryitself or from other countries, who have the mostadvanced knowledge on the subject, access to thebest facilities, the newest drugs, and state-of-the-artequipment. Guidelines thus developed are difficult forpracticing physicians to follow in local realities andcircumstances. Working with the six-step methodol-ogy, the clinical content experts provided teams withall of the evidence-based information necessary todevelop the guideline. The teams could then take theevidence-based clinical information and incorporate itinto a new system of care in a way that would work intheir facility and local reality. By becoming thoroughlyfamiliar with the clinical content—rather than learningit, perhaps superficially, through a training or reading—doctors became more knowledgeable on the topic. Inaddition, the sense of ownership that came fromdeveloping the guideline helped alleviate some of theresistance that would have come if the guideline hadbeen imposed in a top-down manner.

■ Communication of standards happenedsimultaneously with the development ofstandards, since those creating the guidelinewere also the users, eliminating the need for aseparate dissemination step. This method forclinical guideline development provides that the samepeople who design guidelines implement them,eliminating the need for a separate step for communi-cation and dissemination. Communication of thechanges in both the clinical content and organization

22 ■


of the system of healthcare delivery for women withPIH was an integrated part of the QI project. Beforeclinical content trainings on PIH were held, teammembers participated in training of trainers courses togain the skills necessary to teach others the updatedclinical information and QI methodology. Teammembers at the training were expected to share theinformation with their team. From the outset of theproject and the first clinical content training, the newinformation was passed on to health professionals inthe pilot facilities through several means, such asweekly rounds and department meetings. As soon asdecisions were made on changes in clinical content,and before the guideline was officially published anddistributed, physicians in the pilot facilities werealready managing patients with PIH according to theseupdated practices. This allowed for questions,clarifications, and identification of possible problemsbefore the guideline was finalized and printed.

■ A strategic area of importance to thoseworking on the project should be chosen forthe initial quality improvement demonstration.This decision must be made at the local level in orderto gain the support of those responsible for implemen-tation. In the case of Tver, international experts andMinistry of Health officials were encouraging thesteering committee in Tver to choose anemia inpregnant women as the improvement area since this isa widespread problem throughout Russia. However,Tver department of health officials insisted that theywanted to undertake improvement efforts for preg-nancy-induced hypertension because it was the singlelargest cause of maternal mortality, had high frequencyin Tver Oblast, and was problematic for physicians totreat. In the end, the project strongly impacted andimproved the state of PIH in Tver Oblast. Since PIH

■ 23


was a critical problem, which has been significantlyimproved through the quality improvement project,oblast leadership as well as many facility administra-tors, physicians, and other medical personnel havebecome strong proponents of the guideline and thequality improvement methodology.

End Notes

i. <www.healthquality.ru>.

ii. Bradley, C.S. Eclampsia. MEDLINEplus MedicalEncyclopedia. Available at <www.nlm.nih.gov/medlineplus/ency/article/000899.htm>. (8/20/01)

iii. Paul B. Batalden, MD, and Patricia K. Stoltz, PA-C.1993. A framework for the continual improvement ofhealthcare. Joint Commission Journal. 19(10):424–52.

iv. H. Abdallah, O. Chernobrovkina, A. Korotkova, R.Massoud, and B. Burkhalter. 2002. Improving theQuality of Care for Women with Pregnancy-InducedHypertension Reduces Costs in Tver, Russia. Opera-tions Research Results 2(4). Bethesda, MD: Publishedfor the United States Agency for International Develop-ment (USAID) by the Quality Assurance Project.

24 ■

Developing Evidence-BasedStandards for Pregnancy-InducedHypertension in Russia: Summary

As part of a quality improvement effort in Tver Oblast, Rus-sia, multi-disciplinary, facility-level teams and the TverOblast Department of Health, in close collaboration withthe Quality Assurance Project and the Central Public HealthResearch Institute of the Ministry of Health of the RussianFederation, created and implemented a clinical/organiza-tional guideline on the system of healthcare delivery forwomen with pregnancy-induced hypertension (PIH). Thequality improvement project was based on a six-step meth-odology that combines the clinical and organizational as-pects of the system of healthcare delivery for women withPIH. Teams of practicing physicians, nurses, midwives,and administrators developed the guideline as part of alarger quality improvement effort in collaboration with clini-cal experts who provided evidence-based clinical infor-mation. This methodology is unique in that the samepeople who created the guideline were responsible forimplementing it, making it more functional and relevant tolocal realities. As a consequence, significant changes inthe management of PIH and in the system of healthcaredelivery for women with PIH have led to reduced maternalmorbidity and mortality.

quality improvement case study - usaid assist · of pih diagnosis, treatment, and management....

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