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Implementation of a Best Practice in Cardiology (BPC) Program Adapted from Get With The Guidelines®in Brazilian Public Hospitals: Study Design and Rationale

Abstract

Background

There are substantial opportunities to improve the quality of cardiovascular care in developing countries through the implementation of a quality program.

Objective

To evaluate the effect of a Best Practice in Cardiology (BPC) program on performance measures and patient outcomes related to heart failure, atrial fibrillation and acute coronary syndromes in a subset of Brazilian public hospitals.

Methods

The Boas Práticas em Cardiologia (BPC) program was adapted from the American Heart Association’s (AHA) Get With The Guidelines (GWTG) Program for use in Brazil. The program is being started simultaneously in three care domains (acute coronary syndrome, atrial fibrillation and heart failure), which is an approach that has never been tested within the GWTG. There are six axes of interventions borrowed from knowledge translation literature that will address local barriers identified through structured interviews and regular audit and feedback meetings. The intervention is planned to include at least 10 hospitals and 1,500 patients per heart condition. The primary endpoint includes the rates of overall adherence to care measures recommended by the guidelines. Secondary endpoints include the effect of the program on length of stay, overall and specific mortality, readmission rates, quality of life, patients’ health perception and patients’ adherence to prescribed interventions.

Results

It is expected that participating hospitals will improve and sustain their overall adherence rates to evidence-based recommendations and patient outcomes. This is the first such cardiovascular quality improvement (QI) program in South America and will provide important information on how successful programs from developed countries like the United States can be adapted to meet the needs of countries with developing economies like Brazil. Also, a successful program will give valuable information for the development of QI programs in other developing countries.

Conclusions

This real-world study provides information for assessing and increasing adherence to cardiology guidelines in Brazil, as well as improvements in care processes. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Cardiovascular Diseases/physiopathology; Heart Failure; Atrial Fibrillation; Acute Coronary Syndrome; Quality Improvement/trends; Guidelines as Topic

Resumo

Fundamento

Existem grandes oportunidades de melhoria da qualidade do cuidado cardiovascular em países em desenvolvimento por meio da implementação de um programa de qualidade.

Objetivo

Avaliar o efeito de um programa de Boas Práticas em Cardiologia (BPC) nos indicadores de desempenho e desfechos clínicos dos pacientes relacionados à insuficiência cardíaca, fibrilação atrial e síndromes coronarianas agudas em um subconjunto de hospitais públicos brasileiros.

Métodos

O programa Boas Práticas em Cardiologia (BPC) foi adaptado do programa Get With The Guidelines (GWTG) da American Heart Association (AHA) para ser utilizado no Brasil. O programa está sendo iniciado em três domínios de cuidado simultaneamente (síndrome coronariana aguda, fibrilação atrial e insuficiência cardíaca), o que consiste em uma abordagem nunca testada no GWTG. Existem seis eixos de intervenções utilizadas pela literatura sobre tradução do conhecimento que abordará barreiras locais identificadas por meio de entrevistas estruturadas e reuniões regulares para auditoria e feedback. Planeja-se incluir no mínimo 10 hospitais e 1500 pacientes por doença cardíaca. O desfecho primário inclui as taxas de adesão às medidas de cuidado recomendadas pelas diretrizes. Desfechos secundários incluem o efeito do programa sobre o tempo de internação, mortalidade global e específica, taxas de readmissão, qualidade de vida, percepção do paciente sobre saúde e adesão dos pacientes às intervenções prescritas.

Resultados

Espera-se, nos hospitais participantes, uma melhoria e a manutenção das taxas de adesão as recomendações baseadas em evidência e dos desfechos dos pacientes. Este é o primeiro programa em melhoria da qualidade a ser realizado na América do Sul, que fornecerá informações importantes de como programas de sucesso originados em países desenvolvidos como os Estados Unidos podem ser adaptados às necessidades de países com economias em desenvolvimento como o Brasil. Um programa bem sucedido dará informações valiosas para o desenvolvimento de programas de melhoria da qualidade em outros países em desenvolvimento.

Conclusões

Este estudo de mundo real proverá informações para a avaliação e aumento da adesão às diretrizes de cardiologia no Brasil, bem como a melhora dos processos assistenciais. (Arq Bras Cardiol. 2020; 115(1):92-99)

Doenças Cardiovasculares/fisiopatologia; Insuficiência Cardíaca; Fibrilação Atrial; Síndrome Coronariana Aguda; Melhoria de qualidade/tendências; Guias como Assunto

Introduction

The Brazilian public health system serves about 70% of the country’s population and functions as Brazil’s primary health care delivery system.11. Victora CG, Barreto ML, do Carmo Leal M, Monteiro CA, Schmidt MI, Paim J, et al. Health conditions and health-policy innovations in Brazil: the way forward. Lancet. 2011;377(9782):2042-53. Despite a number of initiatives taken by the federal government to improve the efficiency of the Brazilian public health system, results have been inconsistent, indicating a great need for improvement.11. Victora CG, Barreto ML, do Carmo Leal M, Monteiro CA, Schmidt MI, Paim J, et al. Health conditions and health-policy innovations in Brazil: the way forward. Lancet. 2011;377(9782):2042-53. , 22. Gragnolati M, Lindelow M, Couttolenc B. Improving efficiency and quality of health care services. In. Twenty years of health system reform in Brazil: an assessment of the Sistema Único de Saúde. Washington, DC: The World Bank; 2013. Furthermore, little has been done to control the under- or overutilization of healthcare resources and barriers that prevent evidence-based therapies from being implemented at the national level.22. Gragnolati M, Lindelow M, Couttolenc B. Improving efficiency and quality of health care services. In. Twenty years of health system reform in Brazil: an assessment of the Sistema Único de Saúde. Washington, DC: The World Bank; 2013.

Significant variability in the quality of care, assessed through performance measures by Brazilian health institutions with the support of the Brazilian Society of Cardiology (SBC), has been observed.33. Wang R, Neuenschwander FC, Lima Filho A, Moreira CM, Santos ES, Reis HJ, et al. Use of evidence-based interventions in acute coronary syndrome - Subanalysis of the ACCEPT registry. Arq Bras Cardiol. 2014;102(4):319-26.

4. Albuquerque DC, Neto JD, Bacal F, Rohde LE, Bernardez-Pereira S, Berwanger O, et al. I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes. Arq Bras Cardiol. 2015;104(6):433-42.
- 55. Piva e Mattos LA, Berwanger O, Santos ES, Reis HJ, Romano ER, Petriz JL, et al. Clinical outcomes at 30 days in the Brazilian Registry of Acute Coronary Syndromes (ACCEPT). Arq Bras Cardiol. 2013;100(1):6-13. Educational initiatives and programs for quality improvement (QI) have been shown to help improve care provided to patients with cardiovascular disease (CVD).66. Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, et al. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012;307(19):2041-9. , 77. Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017;390(10104):1737-46. Thus, a well-aligned clinical intervention such as a multiyear QI program like the American Heart Association (AHA) Get With The Guidelines (GWTG) program, if adapted to the guidelines and health care delivery system of Brazil, might have a significant impact on treatment and outcomes of CVD patients and practice patterns of their caregivers.

GWTG is a QI program created by the AHA and the American Stroke Association (ASA) with the aim of improving the care of patients hospitalized with CVD. It was created to assist hospitals in redesigning the care delivered for heart conditions of high economic burden such as acute coronary syndrome (ACS), atrial fibrillation (AF), heart failure (HF) and stroke and has been validated in the United States over the past 17 years. It has been shown to improve in-hospital quality of care, patient outcomes, and costs.88. Ellrodt AG, Fonarow GC, Schwamm LH, Albert N, Bhatt DL, Cannon CP, et al. Synthesizing lessons learned from get with the guidelines: the value of disease-based registries in improving quality and outcomes. Circulation. 2013;128(22):2447-60.

It is within this context, after appropriate adaptation to the Brazilian healthcare system, that this novel program is being launched. Its main objective is to assess the adherence rates of hospital health professionals to the latest AHA/SBC guidelines’ recommendations on HF, AF and ACS and its effect on patient outcomes and quality of life before and after the implementation of a Best Practice in Cardiology (BPC) program adapted from the GWTG initiative. This initiative in Brazil is the result of a tripartite collaboration of the AHA, the SBC and the Brazilian Ministry of Health, with participation of the Hospital do Coração (HCor), to be tested in selected public hospitals and if proven effective, to be further implemented countrywide.

Methods

BPC is a QI program that was adapted from GWTG and approved by the Institutional Review Board (IRB) of the Coordinating Center under the number 48561715.5.1001.0060. It will be implemented in selected tertiary hospitals of the Brazilian public health system in the five macro-regions of Brazil. The study steering committee and coordination groups are described in Appendix 1.

After acceptance to participate and local IRB approval, the project management group will make an initial visit to make sure that the center meets the infrastructure requirements to participate in the program and to present it to local leadership.

The effect of the program on measures of institutional performance, quality of life and clinical outcomes will be evaluated in a cohort quasi-experimental study design combined with a cohort design, through data collection before and after the implementation of the BPC Program.

Before the intervention, evaluation will occur over a period of approximately two months prior to the implementation of the BPC program in the institution or after the inclusion of the first 15 patients in each arm. Post-intervention evaluation will be conducted after the first intervention and will last approximately 18 months. Patients will be followed through telephone contact at one and six months after discharge by local trained interviewers.

A multidisciplinary team composed of a local leader, doctors, nurses, and patient educators will be responsible for establishing local strategies for improvement and driving the efforts to the local program.

Population

Eligible patients will be consecutive patients aged 18 years or older, admitted to the selected hospitals with a primary diagnosis of acute HF (ICD-10 code I50; I50.0; I50.1 or I50.9), ACS (ICD10 codes: I20.0 to I21.9 and I22.0 to I22.9) or AF/Atrial Flutter (ICD-10 code I-48), regardless of a previous history of any of these conditions, and agree to participate in the study by signing an informed consent form. Screening for AF/flutter patients may be performed in the outpatient clinic. The details of eligibility criteria can be found in Appendix 2.

Definition of performance measures and quality metrics

Performance measures and quality metrics were selected from the American College of Cardiology (ACC)/AHA care metrics on HF,99. Bonow RO, Bennett S, Casey DE, Jr, Ganiats TG, Hlatky MA, Konstam MA, et al. ACC/AHA clinical performance measures for adults with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance Measures) endorsed by the Heart Failure Society of America. J Am Coll Cardiol. 2005;46(6):1144-78. ACS1010. Krumholz HM, Anderson JL, Brooks NH, Fesmire FM, Lambrew CT, Landrum MB, et al. ACC/AHA clinical performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures on ST-Elevation and Non-ST-Elevation Myocardial Infarction). Circulation. 2006;113(5):732-61. and AF1111. Estes NA 3rd, Halperin JL, Calkins H, Ezekowitz MD, Gitman P, Go AS, et al. ACC/AHA/Physician Consortium 2008 Clinical Performance Measures for Adults with Nonvalvular Atrial Fibrillation or Atrial Flutter: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and the Physician Consortium for Performance Improvement (Writing Committee to Develop Clinical Performance Measures for Atrial Fibrillation) Developed in Collaboration with the Heart Rhythm Society. J Am Coll Cardiol. 2008;51(8):865-84. to compose two sets of indicators for each of these conditions. As previously reported, the former set of indicators were derived from class I recommendations of the latest ACC/AHA guidelines and included public comment and a peer review process whereas the latter was derived from other recommendations not following a strict methodology.1212. American College of Cardiology/American Heart Association Task Force on Performance Measures, Bonow RO, Masoudi FA, Rumsfeld JS, Delong E, Estes NA 3rd, et al. ACC/AHA classification of care metrics: performance measures and quality metrics: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. Circulation. 2008;118(24):2662-6. , 1313. Spertus JA, Eagle KA, Krumholz HM, et al. American College of Cardiology and American Heart Association methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care. Circulation. 2005;111(13):1703-1712. These performance and quality metrics have then been reviewed and adapted to be consistent with current guidelines in Brazil.

Twenty-one performance measures were selected, five for HF, nine for ACS and seven for AF ( Table 1 ). Twenty-two other quality metrics were included in the three arms of the program, nine for HF, six for ACS and seven for AF (Appendix 3). Eligible patients are defined as those patients without documented intolerance or contraindications for that specific measure.

Table 1
– Performance measures

The overall rates of adherence to recommendations will be measured using an opportunity-based approach according to ACC/AHA methodology.1414. Eapen ZJ, Fonarow GC, Dai D, O’Brien SM, Schwamm LH, Cannon CP, et al. Comparison of composite measure methodologies for rewarding quality of care: an analysis from the American Heart Association’s Get With The Guidelines program. Circ Cardiovasc Qual Outcomes. 2011;4(6):610-8.

Outcome measures

Length of stay, in-hospital mortality, cardiac mortality at one month and at six months, and readmission within one month and six months due to a cause related to the index admission will be computed.

In addition, quality of life and health perception will be measured using the WHOQOL-BREF questionnaire1515. Fleck MPA, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, et al. Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref. Rev. Saúde Pública. 2000;34(2):178-83. and the Numering Rating Scale (NRS),1616. Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990;13(4):227-36. respectively, at discharge and at six months.

Identification of barriers at baseline

Possible causes of non-adherence to guidelines that require specific interventions will be identified through discussion with the institutions, via a semi-structured interview (Appendix 4). The semi-structured interview will be held before the start of the project for mapping institutional processes and flow of care in each arm in which the institution is enrolled. These interviews aim to identify specific behavioral changes needed to encourage participation in the BPC program as well as adherence to guideline recommendations. Thus, when care processes lead to failure to implement recommended therapies, changes can be implemented to improve a specific process or care.

Data collection

Clinical data from the patients included will be registered on a web database (MySQL version 5.7 or higher) developed specifically for this project. Each hospital will be responsible for its own data collection by a trained local team of data abstractors who will work under the supervision of their local leadership. Data will be abstracted from medical charts and structured interviews made directly with the patients during hospitalization and at one and six months of follow-up.

Data will include demographics, comorbidities and risk factors, symptoms on arrival, health literacy, risk profile according to international standards for each arm of the program,1717. Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, et al. The Seattle Heart Failure Model prediction of survival in heart failure. Circulation. 2006;113(11):1424-33.

18. Remes J, Reunanen A, Aromaa A, Pyörälä K. Incidence of heart failure in eastern Finland: a population-based surveillance study. Eur Heart J. 1992;13(5):588-93.

19. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010;137(2):263-72.

20. Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit: a two year experience with 250 patients. Am J Cardiol. 1967;20(4):457-64.
- 2121. Morrow DA, Antman EM, Charlesworth A, Cairns R, Murphy SA, de Lemos JA, et al. TIMI risk score for ST-elevation myocardial infarction: a convenient, bedside, clinical score for risk assessment at presentation an intravenous nPA for treatment of infarcting myocardium early II trial substudy. Circulation. 2000;102(17):2031-7. in- and out-of-hospital treatment and procedures, discharge medications and secondary prevention, discharge counseling and patients’ adherence to recommendations.

Data Management and Quality Control

All data will be treated as protected health information and securely stored centrally in a password-protected web server, accessible in real time by any approved user through a web browser.

Data accuracy and completeness will be ensured by following the same methodologies of the GWTG.2222. Hao Y, Liu J, Liu J, Smith SC Jr, Huo Y, Fonarow GC, et al. Rationale and design of the Improving Care for Cardiovascular Disease in China (CCC) project: a national effort to prompt quality enhancement for acute coronary syndrome. Am Heart J. 2016 Sep;179:107-15. , 2323. Lewis WR, Piccini JP, Turakhia MP, Curtis AB, Fang M, Suter RE, et al. Get With The Guidelines AFIB: novel quality improvement registry for hospitalized patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2014;7(5):770-7.

QI Interventions and Hospital Recognition

As opposed to the approach taken in the U.S., the Brazilian program uses a didactic framework based on Michie et al.2424. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. Interventions were grouped in seven domains aiming to cause behavioral change (facilitation and restriction; modeling; environmental restructuring; education; incentives and persuasion; coercion; and training). These groups of interventions will be implemented in all participating institutions and can be emphasized individually throughout the study according to the barriers identified at baseline and to the monthly reports on overall and specific adherence to recommendations. The description of the interventions embedded in each of these groups is available in Figure 1 .

Figure 1
Intervention axes *Target of behavior change: health professionals &Target of behavior change: Patients and health professionals # Target of behavior change: Health managers.

Coordination of these activities will be made by a nurse, member of the Management Group, and will include checklists and reminders, webinars, automatic and real time reports through an electronic database, educational materials, quarterly meetings for audit and feedback, and hospitals’ recognition and training on QI methodologies for the implementation of rapid improvement cycles by the use of the Institute for Healthcare Improvement (IHI) ’s tools.2525. Institute for Healthcare Improvement. Quality Improvement Essentials Toolkit [Internet]. Boston: Institute for Healthcare Improvement; 2019 [citado 4 jan. 2018]. Disponível em: http://www.ihi.org/resources/Pages/Tools/Quality-Improvement-Essentials-Toolkit.aspx.
http://www.ihi.org/resources/Pages/Tools...
, 2626. Deming WE. The new economics for industry, government, education. 2nd ed. Cambridge, Massachussets: The MIT Press; 1994. Concepts of improvement such as training of a QI team and establishment of goals based on the barriers that need to be overcame and monitoring and analysis of results will be used throughout the study.

The electronic reports will capture real time information when completed in the study’s electronic database. The reports will include specific run charts describing the temporal trends on a monthly basis of the overall and specific adherence rates of the institution in relation to an established goal of 85% and to the median rates observed in the selected period for that same institution.2727. Perla RJ, Provost LP, Murray SK. The run chart: a simple analytical tool for learning from variation in healthcare processes. BMJ Qual Saf. 2011;20(1):46-51. Each institution will be able to see, in real time, their own run charts and the charts showing average rates of the other participating (anonymous) institutions. The coordinating center will be able to follow all the participating institutions concomitantly.

For the purposes of this project, we established as a goal a threshold of 85% based on previously reported GWTG results, where clinical outcomes improved when institutions reached this threshold.2828. Thomas K, Miller A, Poe G, American Heart Association/American Stroke Association, Grand Rapids, MI2American Heart Association/American Stroke Association, et al. The Association of Award Recognition From Get With the Guidelines-Resuscitation with Improved Survival Rates in In-Hospital Cardiac Arrest Events. Circ Cardiovasc Qual Outcomes. 2016;9:A252. Hospitals will be recognized by SBC with a bronze award if they reach this threshold for at least three consecutive months, with a silver award if they sustain these results for at least six months and with a gold award if they continue on the threshold or above it for 12 consecutive months.

Data analysis

Data will be analyzed using R program version 3.4.0 or higher.

Hospitals will be excluded from the analysis of a performance measure if less than 10 patients are noted in the denominator for that measure.

Continuous variables with normal distribution will be summarized as mean and standard deviation, and those with skewed distribution as median and 25thand 75thpercentiles. Ordinal or categorical variables will be reported as absolute frequencies, percentages and 95% confidence intervals. Missing data will be addressed on an analysis-specific basis and considered non-compliance for the specific measure.

The longitudinal effect of the program on HF, ACS and AF will be assessed by comparing the overall rates of adherence to the recommendations before and after its implementation in the participating institutions on a quarterly basis, using a generalized linear mixed-effect model (GLMM) for time trend analysis over a time horizon of 18 months. It will be expressed by means of proportions and their respective 95% confidence intervals. It is expected that the random effect approach used by GLMM will account for between-site differences at baseline.2929. Hedeker D. Generalized Linear Mixed Models. In: Everitt BS, Rabe-Hesketh S, Skrondal A, eds. Encyclopedia of Statistics in Behavioral Science: Longitudinal/Multilevel Models: Wiley; 2005.

Quality of life scores will be calculated using the methodology reported in the WHOQOL-BREF questionnaire manual.3030. Harper A. WHOQOL-BREF: Introduction, administration, scoring and generic version of the assessment. In: Orley J, Power M, Kuyken W, Sartorius N, Bullinger M, Harper A, eds. Programme on Mental Health [Internet]. Geneva: World Health Organization; 1996 [citado 4 jan. 2018]. Disponível em: http://www.who.int/mental_health/media/en/76.pdf.
http://www.who.int/mental_health/media/e...
The total score consists of the average of the scores of the four domains of the instrument (physical health, psychological health, social relationships and environment).3030. Harper A. WHOQOL-BREF: Introduction, administration, scoring and generic version of the assessment. In: Orley J, Power M, Kuyken W, Sartorius N, Bullinger M, Harper A, eds. Programme on Mental Health [Internet]. Geneva: World Health Organization; 1996 [citado 4 jan. 2018]. Disponível em: http://www.who.int/mental_health/media/en/76.pdf.
http://www.who.int/mental_health/media/e...
The internal consistency of the instrument will be calculated using the Cronbach’s alpha coefficient. It shall be considered appropriate a value above 0.7.

The results observed over time in the participating institutions on the dependent variables of mortality, readmission rate, length of stay, variation in quality of life and in health perception will be adjusted by multivariable GLMM for demographic, clinical and socioeconomic variables, disease severity, risk factors, initial self-perception of health (NRS), level of health literacy and degree of specific and overall adherence of the institution to clinical recommendations. The variables will be included in the model when associated in the univariate or bivariate analysis (p <0.20) and according to clinical relevance. Odds ratios or relative risks will be calculated, as appropriate, with respective 95% CI.

All analyses will be two-tailed and performed independently for each arm of the protocol using a 0.05 significance level.

Discussion

Why is this project needed?

In Brazil, a large country with a complex universal healthcare system,11. Victora CG, Barreto ML, do Carmo Leal M, Monteiro CA, Schmidt MI, Paim J, et al. Health conditions and health-policy innovations in Brazil: the way forward. Lancet. 2011;377(9782):2042-53. the quality of cardiovascular care has been the subject of evaluation and concern. Patient access to the various levels of healthcare varies throughout the country and the quality of care delivered is highly heterogeneous.11. Victora CG, Barreto ML, do Carmo Leal M, Monteiro CA, Schmidt MI, Paim J, et al. Health conditions and health-policy innovations in Brazil: the way forward. Lancet. 2011;377(9782):2042-53. , 22. Gragnolati M, Lindelow M, Couttolenc B. Improving efficiency and quality of health care services. In. Twenty years of health system reform in Brazil: an assessment of the Sistema Único de Saúde. Washington, DC: The World Bank; 2013.

As in other parts of the world and in spite of medical society efforts in publishing clinical guidelines, mortality related to CVD remains high, reflecting the difficulty of patients having access to recommended therapies and care at appropriate times.3131. Institute of Medicine. Committee on Quality of Health Care in America. In: Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press; 2001. , 3232. Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular health in Brazil: trends and perspectives. Circulation. 2016;133(4):422-33.

Registries performed by SBC in multiple regions of Brazil have shown a high variation in the quality of care delivered for cardiovascular conditions of high economic burden,3232. Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular health in Brazil: trends and perspectives. Circulation. 2016;133(4):422-33. , 3333. Azambuja MI, Foppa M, Maranhao MF, Achutti AC. Economic burden of severe cardiovascular diseases in Brazil: an estimate based on secondary data. Arq Bras Cardiol. 2008;91(3):148-55. such as coronary artery disease (CAD)33. Wang R, Neuenschwander FC, Lima Filho A, Moreira CM, Santos ES, Reis HJ, et al. Use of evidence-based interventions in acute coronary syndrome - Subanalysis of the ACCEPT registry. Arq Bras Cardiol. 2014;102(4):319-26. , 3434. Berwanger O, Piva e Mattos LA, Martin JF, Lopes RD, Figueiredo EL, Magnoni D, et al. Evidence-based therapy prescription in high-cardiovascular risk patients: the REACT study. Arq Bras Cardiol. 2013;100(3):212-20. HF,44. Albuquerque DC, Neto JD, Bacal F, Rohde LE, Bernardez-Pereira S, Berwanger O, et al. I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes. Arq Bras Cardiol. 2015;104(6):433-42. stroke, and AF.3535. Lopes RD, de Paola AA, Lorga Filho AM, Consolim-Colombo FM, Andrade J, Piva E Mattos LA, et al. Rationale and design of the First Brazilian Cardiovascular Registry of Atrial Fibrillation: The RECALL study. Am Heart J. 2016 Jun;176:10-6. These registries have shown that adherence to evidence-based therapies remains suboptimal and, at least for HF, the lack of optimal therapies is more critical in the public non-academic institutions of the poorest regions of Brazil.44. Albuquerque DC, Neto JD, Bacal F, Rohde LE, Bernardez-Pereira S, Berwanger O, et al. I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes. Arq Bras Cardiol. 2015;104(6):433-42. It was also observed that morbidity and mortality related to HF are much higher than those observed in developed countries, even when adjusting for region, number of hospital beds and type of institution. The Brazilian registries have contributed enormously in demonstrating how these highly prevalent conditions are being approached across the country, but they have not addressed the gap in the implementation of interventions that may have prevented improvements in the quality of care. Furthermore, they have not controlled for situations where specific therapies are not recommended or are contraindicated.33. Wang R, Neuenschwander FC, Lima Filho A, Moreira CM, Santos ES, Reis HJ, et al. Use of evidence-based interventions in acute coronary syndrome - Subanalysis of the ACCEPT registry. Arq Bras Cardiol. 2014;102(4):319-26. , 44. Albuquerque DC, Neto JD, Bacal F, Rohde LE, Bernardez-Pereira S, Berwanger O, et al. I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes. Arq Bras Cardiol. 2015;104(6):433-42. , 3434. Berwanger O, Piva e Mattos LA, Martin JF, Lopes RD, Figueiredo EL, Magnoni D, et al. Evidence-based therapy prescription in high-cardiovascular risk patients: the REACT study. Arq Bras Cardiol. 2013;100(3):212-20. , 3535. Lopes RD, de Paola AA, Lorga Filho AM, Consolim-Colombo FM, Andrade J, Piva E Mattos LA, et al. Rationale and design of the First Brazilian Cardiovascular Registry of Atrial Fibrillation: The RECALL study. Am Heart J. 2016 Jun;176:10-6.

The two randomized trials (BRIDGE-ACS and IMPACT-AF) performed in Brazil for testing multifaceted interventions to promote adherence to guideline recommendations have shown that the implementation of QI interventions is feasible and can be effective.66. Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, et al. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012;307(19):2041-9. , 77. Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017;390(10104):1737-46. However, these studies did not consider barriers related to local context, did not test if the results observed on adherence to recommendations are sustained over time or the effect of the interventions on patients’ quality of life.66. Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, et al. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012;307(19):2041-9. , 77. Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017;390(10104):1737-46. The BRIDGE-ACS trial, for example, which was performed mostly in academic institutions,3636. Tam LM, Fonarow GC, Bhatt DL, Grau-Sepulveda MV, Hernandez AF, Peterson ED, et al. Achievement of guideline-concordant care and in-hospital outcomes in patients with coronary artery disease in teaching and nonteaching hospitals: results from the Get With The Guidelines-Coronary Artery Disease program. Circ Cardiovasc Qual Outcomes. 2013;6(1):58-65. achieved at most 68% adherence to acute therapies and only 51% adherence if all acute and discharge therapies were considered, with no impact on 30-day mortality.66. Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, et al. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012;307(19):2041-9. The GWTG program show that hospitals achieving at least 85% of compliance to evidence-based therapies reached better results on clinical outcomes.3737. Hong Y, LaBresh KA. Overview of the American Heart Association “Get with the Guidelines” programs: coronary heart disease, stroke, and heart failure. Crit Pathw Cardiol. 2006;5(4):179-86. , 3838. Thomas K, Miller A, Poe G. American Heart Association/American Stroke Association, Grand Rapids, MI2American Heart Association/American Stroke Association, et al. The Association of Award Recognition From Get With the Guidelines-Resuscitation with Improved Survival Rates in In-Hospital Cardiac Arrest Events. Circ Cardiovasc Qual Outcomes. 2016;9:A252.

These findings provide a compelling argument in support of the implementation of a QI initiative in Brazilian hospitals that considers the complexity of the local reality and that has already been tested and proven effective elsewhere. The GWTG program, implemented in nearly 50% of all U.S. hospitals, has shown a sustained effect on mortality, length of stay and costs.3939. Heidenreich PA, Lewis WR, LaBresh KA, Schwamm LH, Fonarow GC. Hospital performance recognition with the Get With The Guidelines Program and mortality for acute myocardial infarction and heart failure. Am Heart J. 2009;158(4):546-53. There is thus the potential to decrease the economic burden imposed by ACS, HF and AF on the Brazilian health system.

What is different in the Brazilian program?

Despite the fact that the GTWG program has been deployed in the U.S. for more than 15 years, only as recently as 2016 has another country (China) taken advantage of a similar ACS program.3636. Tam LM, Fonarow GC, Bhatt DL, Grau-Sepulveda MV, Hernandez AF, Peterson ED, et al. Achievement of guideline-concordant care and in-hospital outcomes in patients with coronary artery disease in teaching and nonteaching hospitals: results from the Get With The Guidelines-Coronary Artery Disease program. Circ Cardiovasc Qual Outcomes. 2013;6(1):58-65. In Brazil we are starting the program in three different dimensions: ACS, AF and HF. A nationwide quality program focusing on multiple conditions, including outpatient clinics has never been tested within the GWTG experience.88. Ellrodt AG, Fonarow GC, Schwamm LH, Albert N, Bhatt DL, Cannon CP, et al. Synthesizing lessons learned from get with the guidelines: the value of disease-based registries in improving quality and outcomes. Circulation. 2013;128(22):2447-60. , 2222. Hao Y, Liu J, Liu J, Smith SC Jr, Huo Y, Fonarow GC, et al. Rationale and design of the Improving Care for Cardiovascular Disease in China (CCC) project: a national effort to prompt quality enhancement for acute coronary syndrome. Am Heart J. 2016 Sep;179:107-15. Also, the notion of patient-reported outcomes including quality of life has been contemplated for the BPC program and may help ministries and cardiology societies in directing health policies to local needs.

The identification of barriers and facilitators in each hospital is considered one of the key steps in the success of clinical implementation strategies. In this project, we are using as a conceptual model a didactic framework proposed by Michie, Stralen and West,2424. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. which integrates dynamic and interactive mechanisms to promote behavioral changes resulting from the interaction between the individual (capability and motivation) and the environment (opportunities).2424. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. This model will also help the coordinating center in identifying and acting on specific institutional needs during the course of the project. In doing so, in some institutions, intervention will be focused on improving capacity, in others on increasing motivation, and still in others to increase or to restrain the supply of opportunities, individually or jointly, depending on the objectives of each institution. Interventions such as the award program that was considered one of the keys for success in the GWTG experience will be emphasized in all participating institutions.4040. Birtcher KK, Pan W, Labresh KA, Cannon CP, Fonarow GC, Ellrodt G. Performance achievement award program for Get With The Guidelines--Coronary Artery Disease is associated with global and sustained improvement in cardiac care for patients hospitalized with an acute myocardial infarction. Crit Pathw Cardiol. 2010;9(3):103-12.

Lessons learned from the IHI open school experience, such as shaping the audit and feedback intervention with run charts, will be also used in this project.4141. Institute for Health Care Improvement.QI Essentials Toolkit: Run chart &Control Chart Internet. [Cited in 2018 Jan 23]. Available from: www.fammed.usouthal.edu/Guides&JobAids/QILandingPage/Run%20Chart%20Control%Chart.pdf
www.fammed.usouthal.edu/Guides&JobAids/Q...
These approaches consider institutional longitudinal data on the several quality metrics not only in relation to the average benchmarks of the other participating institutions, but also to the goal established for that institution by the median line of the scores obtained for the entire period of observation.2727. Perla RJ, Provost LP, Murray SK. The run chart: a simple analytical tool for learning from variation in healthcare processes. BMJ Qual Saf. 2011;20(1):46-51. , 4141. Institute for Health Care Improvement.QI Essentials Toolkit: Run chart &Control Chart Internet. [Cited in 2018 Jan 23]. Available from: www.fammed.usouthal.edu/Guides&JobAids/QILandingPage/Run%20Chart%20Control%Chart.pdf
www.fammed.usouthal.edu/Guides&JobAids/Q...
This feedback loop allows the institution to continuously evaluate itself and redesign processes in rapid improvement cycles,2525. Institute for Healthcare Improvement. Quality Improvement Essentials Toolkit [Internet]. Boston: Institute for Healthcare Improvement; 2019 [citado 4 jan. 2018]. Disponível em: http://www.ihi.org/resources/Pages/Tools/Quality-Improvement-Essentials-Toolkit.aspx.
http://www.ihi.org/resources/Pages/Tools...
, 2626. Deming WE. The new economics for industry, government, education. 2nd ed. Cambridge, Massachussets: The MIT Press; 1994. considering how their performance differs from the objective and whether adjustments made in their multidisciplinary interventions are resulting in sustained improvement.

Conclusion

This novel QI program will be provided to selected public institutions in Brazil addressing issues pertaining to the local context that will allow for the identification of specific barriers to the adoption of standards of care. It has the potential to provide solutions that can result in sustained improvement in adherence to evidence-based therapies and patient outcomes.

It is hoped that the implemented strategies will contribute to creating an organizational culture focused on the construction and exchange of knowledge among the institutions nationwide, thereby advancing the quality of cardiovascular health care in Brazil.

Acknowledgements

To Dr. Leopoldo Soares Piegas and to Dr. Felix José Alvares Ramires for the contributions made to the initial design of this Project and for sharing their experience on implementing QI strategies on HF and ACS in the HCor.

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  • Study Association
    This study is not associated with any thesis or dissertation work.
  • Ethics approval and consent to participate
    This study was approved by the Ethics Committee of the Hospital do Coração under the protocol number 48561715.5.1001.0060. All the procedures in this study were in accordance with the 1975 Helsinki Declaration, updated in 2013. Informed consent was obtained from all participants included in the study.
  • Financial support
    This study is supported by TAKEDA and Pfizer Independent Grants for Learning and Change, in partnership with the SBC, and by a grant of the Brazilian Ministry of Health through PROADI-SUS.42ALPR receives scholarships from Brazilian research agencies CNPq and FAPEMIG.
  • Sources of Funding
    This study was funded by PROADI-SUS and partially funded by American Heart Association

Publication Dates

  • Publication in this collection
    07 Aug 2020
  • Date of issue
    July 2020

History

  • Received
    18 July 2019
  • Reviewed
    14 Aug 2019
  • Accepted
    14 Aug 2019
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