Reimagining Evidence Generation for Heart Failure and the Role of Integrated Health Care Systems
2022; Lippincott Williams & Wilkins; Volume: 15; Issue: 4 Linguagem: Inglês
10.1161/circoutcomes.121.008292
ISSN1941-7705
Autores Tópico(s)Blood Pressure and Hypertension Studies
ResumoHomeCirculation: Cardiovascular Quality and OutcomesVol. 15, No. 4Reimagining Evidence Generation for Heart Failure and the Role of Integrated Health Care Systems Free AccessArticle CommentaryPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessArticle CommentaryPDF/EPUBReimagining Evidence Generation for Heart Failure and the Role of Integrated Health Care Systems Tariq Ahmad, MD, MPH and Nihar R. Desai, MD, MPH Tariq AhmadTariq Ahmad Correspondence to: Tariq Ahmad, MD, MPH, Yale University School of Medicine, 333 Cedar St, New Haven, CT 06517, Email E-mail Address: [email protected] https://orcid.org/0000-0001-7596-4697 Section of Cardiovascular Medicine and the Heart and Vascular Center, Yale University School of Medicine/Yale New Haven Health System, CT. and Nihar R. DesaiNihar R. Desai Nihar R. Desai, MD, MPH, Yale University School of Medicine, 333 Cedar St, New Haven, CT 06517, Email E-mail Address: [email protected] https://orcid.org/0000-0003-2384-2545 Section of Cardiovascular Medicine and the Heart and Vascular Center, Yale University School of Medicine/Yale New Haven Health System, CT. Originally published11 Mar 2022https://doi.org/10.1161/CIRCOUTCOMES.121.008292Circulation: Cardiovascular Quality and Outcomes. 2022;15Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: March 11, 2022: Ahead of Print Approximately 3 decades ago, the standard of care for patients with heart failure with reduced ejection fraction was digoxin and diuretics.1 The path to defining guideline-recommended therapy for heart failure with reduced ejection fraction then began, initially with the CONSENSUS trial in 1987 and involving thousands of clinical investigators over time from across the globe working collaboratively on randomized controlled trials, which have led to the identification of several classes of highly efficacious therapies that reduce mortality in heart failure with reduced ejection fraction including ACE (angiotensin-converting enzyme) inhibitors, angiotensin receptor blockers, β-blockers, aldosterone antagonists, angiotensin receptor–neprilysin inhibitors, and SGLT2 (sodium glucose cotransporter 2) inhibitors. When used appropriately, these medications dramatically reduce suffering and risk of death from heart failure.2 Despite these successes, however, a fundamental challenge has emerged: the widening gap between clinical evidence and clinical practice. Debates about the shift to quadruple therapy are juxtaposed with contemporary analyses demonstrating that single-digit percentages of eligible patients are on current guideline-recommended medical therapies.3 Thus, there is a pressing need to rethinking of our approach to evidence generation and implementation science in heart failure.To understand and reduce this gap between clinical evidence and clinical adoption, investigators initially reached for traditional methods to examine practice patterns and uptake, developing a new clinical registry and mining data from existing registries.4,5 The resultant findings have provided important insights; however, this traditional approach has again left us with only limited answers (Figure). The conventional heart failure registry may be well suited to describe overall adoption patterns but is ill-suited to fully capture a patient's journey, understand real-time diffusion of novel therapies, and rigorously evaluate implementation strategies. If our aim is to create efficient, cost-effective, and innovative processes for continual quality improvement in heart failure, we need new approaches.Download figureDownload PowerPointFigure. Our proposal on how integrated health care systems can play a key role in addressing the challenges of heart failure research today that requires a far more cost-effective and rapid innovation-implementation cycle. EHR indicates electronic health record.Two major developments have occurred in health care over the last decade that can allow us to move closer to the stated goal of more efficient and rapid innovation-implementation cycles in heart failure: the consolidation of hospitals and provider groups into health care systems and the widespread use of electronic health record systems. In this perspective, we describe our efforts at creating such an infrastructure for heart failure at the Yale New Haven Health System—one of the largest health systems in the United States spanning 6 hospitals linked by a single electronic health record. Though we describe the experience of a single health care system, the foundational elements and infrastructure illustrated is rapidly transportable and scalable at other integrated health care systems.As a first step, we developed a real-time, longitudinal, automated, electronic health record–based registry of all heart failure patients within the health system (n=28 000 at the time of manuscript submission; https://www.clinicaltrials.gov; unique identifier: NCT04237701; Figure). The registry enables comprehensive phenotyping of patients, capturing sociodemographic data, imaging, laboratories, medications with doses, and care utilization across inpatient and ambulatory settings. Furthermore, it has integrated geospatial information to provide zip code level characterization of patients customizable for clinical queries (eg, patients not on sacubitril/valsartan with an LVEF ≤40% who have had 2 readmissions during the last year). This registry did not require substantial resources to create, requiring only a computer analyst and pharmacist, along with input from clinical experts. When comparing the YNHHS HF registry to the CHAMP-HF registry, we have seen near identical values for the baseline characteristics of patients (age, sex, race, and ejection fraction), as well as prescription rates for established guideline-directed medical therapies. Taken together, it appears the Yale HF registry has a greater number of patients than CHAMP-HF and provides similar capability for profiling patients, examining patterns of care, and ascertaining clinical outcomes of interest at a fraction of the cost.A unique benefit of the YNHHS registry and where it deserves to be distinguished from CHAMP-HF is that it can serve as an evidence generation engine beyond descriptive analyses as it is a platform for enabling rapid learning through iterative interventions (Table). For example, as COVID-19 infections spread across our health care system, we were rapidly able to add testing status to the registry. Doing so allowed for a real-time examination of the impact of COVID-19 on patients with heart failure within the Yale Health System: these data were analyzed, written, and submitted for publication in <2 weeks, and our principal results have since been frequently replicated.6 Furthermore, we are able to readily perform longitudinal analyses on how patients with heart failure have fared after recovering from COVID-19.Table. Examples of Studies Possible Using an EHR-Based Registry Within an Integrated Health Care SystemType of studyDescriptiveLongitudinalInterventionalImplementationEHR-based registryReport on cross-sectional data across patient population of interest at current timeExamine trends in therapies and outcomesExamine the randomized impact of interventionsExamine the impact of interventions aimed at improving implementation of appropriate therapiesExampleDescribing characteristics of patients with heart failure infected with COVID-19Describe trends in use of guideline-directed medical therapy among eligible patients and clinical outcomes related to this interventionRandomize clinicians to getting information about patient prognosis and study impact on clinical outcomes(REVeAL-HF)Inform clinicians about evidence-based therapies for their patients with HFrEF and facilitate prescription of these therapies(PROMPT-HF)COVID-19 indicates coronavirus disease 2019; EHR; electronic health record; HFrEF, heart failure with reduced ejection fraction; PROMPT-HF, Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure; and REVeAL-HF, Risk Evaluation and Its Impact on Clinical Decision Making and Outcomes in Heart Failure.This infrastructure also permits streamlined execution of registry-embedded randomized controlled pragmatic trials, several of which are currently ongoing. The first of these was REVeAL-HF (Risk Evaluation and Its Impact on Clinical Decision Making and Outcomes in Heart Failure; https://www.clinicaltrials.gov; unique identifier: NCT03845660), reported at the American Heart Association Scientific Sessions 2021 as a Late Breaking Clinical Trial. REVeAL-HF tested whether an electronic alert system that informs practitioners about their hospitalized heart failure patient's 1-year predicted mortality using validated data from the electronic health record would improve use of appropriate clinical interventions and result in better patient outcomes. This trial began enrollment on November 27, 2019, and completed its planned enrollment of 3214 patients in 1 year, making it the fastest enrolling heart failure clinical trial in history (presented as an LBCT at AHA 2021).7Finally, the Yale HF registry can be leveraged to rigorously evaluate the impact of implementation interventions on the quality of care and clinical outcomes for patients with heart failure. Specifically, we are running the PROMPT-HF (Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure; https://www.clinicaltrials.gov; unique identifier: NCT04514458), pragmatic randomized controlled trial in the outpatient and inpatient setting that are ongoing with a planned enrollment of ≈2500 patients during a 1-year period. The aim of PROMPT-HF is to test the impact of a provider focus group informed, patient tailored, decision alert system embedded in clinical workflow that delivers patient-specific opportunities to optimize evidence-based therapies for their patients with heart failure with reduced ejection fraction and facilitates prescription of these therapies will increase in the use of guideline-directed medical therapies across our health care system.As data science transforms every other aspect of our lives, it is now clear that the needs for clinical research in heart failure are unmet by traditional approaches that do not allow rapid transfer of actionable data. Large, integrated health care systems should focus on developing systems that can adequately scale to handle the data influx and provide sufficient capacity for analytic needs. The requirement for privacy and reliability of data will be a central priority as we progress toward collaboration across multiple health systems, which will be a nonnegotiable requirement if we are to create a true learning health care system. For this to occur, health care system leaders will need to prioritize partnership, data standardization, system integration, and distributed computing; these requirements have been previously articulated in detail by our colleagues at Yale.8–10Our experience demonstrates the feasibility and potential of a novel paradigm, the development of a robust ecosystem for evidence generation in heart failure at a fraction of the cost and resources of traditional approaches. An obvious next step would be to create a consortium of health care systems, where insights into the management of hundreds of thousands of heart failure patients can be examined and interventions can be iteratively deployed to accelerate improvement. This would require investments in infrastructure, adoption of a common data model (which is underway), and coordination of scientific pursuits. While these challenges deserve to be discussed, the potential to transform our evidence generation enterprise for heart failure and advance the care of millions of patients cannot be understated. Clearly, we have only scratched the surface in terms of what might be possible at the learning health care system we are striving to create, where knowledge generation and implementation science is embedded into daily care delivery to achieve patient-centered, high-value, equitable heart failure care.Article InformationSources of FundingNone.Disclosures Dr Ahmad is a consultant for Sanofi-Aventis, Amgen, and Cytokinetics. He has research funding from Boehringer Ingelheim, AstraZeneca, Cytokinetics, and Relypsa. Dr Desai is a consultant and has research funding from Amgen, Boehringer Ingelheim, Cytokinetics, Relypsa, and Novartis and does Contracted Research at the Centers for the Centers for Medicare and Medicaid Services.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.For Sources of Funding and Disclosures, see page 246.Correspondence to: Tariq Ahmad, MD, MPH, Yale University School of Medicine, 333 Cedar St, New Haven, CT 06517, Email tariq.[email protected]eduNihar R. Desai, MD, MPH, Yale University School of Medicine, 333 Cedar St, New Haven, CT 06517, Email nihar.[email protected]eduReferences1. Sacks CA, Jarcho JA, Curfman GD. Paradigm shifts in heart-failure therapy–a timeline.N Engl J Med. 2014; 371:989–991. doi: 10.1056/NEJMp1410241CrossrefMedlineGoogle Scholar2. Vaduganathan M, Claggett BL, Jhund PS, Cunningham JW, Pedro Ferreira J, Zannad F, Packer M, Fonarow GC, McMurray JJV, Solomon SD. 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The promise of big data and digital solutions in building a cardiovascular learning system: opportunities and barriers.Methodist Debakey Cardiovasc J. 2020; 16:212–219. doi: 10.14797/mdcj-16-3-212CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Ghazi L, O'Connor K, Yamamoto Y, Fuery M, Sen S, Samsky M, Riello R, Huang J, Olufade T, McDermott J, Inzucchi S, Velazquez E, Wilson F, Desai N and Ahmad T (2023) Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial, American Heart Journal, 10.1016/j.ahj.2022.12.002, 257, (111-119), Online publication date: 1-Mar-2023. Shah N, Ghazi L, Yamamoto Y, Martin M, Simonov M, Riello R, Faridi K, Ahmad T, Wilson F and Desai N (2022) Rationale and design of a pragmatic trial aimed at improving treatment of hyperlipidemia in outpatients with very high risk atherosclerotic cardiovascular disease: A pragmatic trial of messaging to providers about treatment of hyperlipidemia (PROMPT-LIPID), American Heart Journal, 10.1016/j.ahj.2022.07.002, 253, (76-85), Online publication date: 1-Nov-2022. Ahmad T, Desai N and Velazquez E (2022) SGLT2 Inhibitors Should Be Considered for All Patients With Heart Failure, Journal of the American College of Cardiology, 10.1016/j.jacc.2022.08.005, 80:14, (1311-1313), Online publication date: 1-Oct-2022. Ghazi L, Yamamoto Y, Riello R, Coronel-Moreno C, Martin M, O'Connor K, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi S, Velazquez E, Wilson F, Desai N and Ahmad T (2022) Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice, Journal of the American College of Cardiology, 10.1016/j.jacc.2022.03.338, 79:22, (2203-2213), Online publication date: 1-Jun-2022. April 2022Vol 15, Issue 4 Advertisement Article InformationMetrics © 2022 American Heart Association, Inc.https://doi.org/10.1161/CIRCOUTCOMES.121.008292PMID: 35272506 Originally publishedMarch 11, 2022 Keywordsstroke volumeneprilysinheart failuredelivery of health careconsensusPDF download Advertisement SubjectsHeart FailureQuality and Outcomes
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