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Mis-GUIDED—The Importance of Negative Trials of Health Care Delivery and Implementation Science

Mis-GUIDED—The Importance of Negative Trials of Health Care Delivery and Implementation Science Modern medicine is a glittering edifice of possibilities. But it has also become a house of cards. For the average patient, who has multiple chronic conditions playing out among a host of psychological and socioeconomic issues, navigating the health care system is challenging. For clinicians and institutions, designing and executing complex care plans has also become challenging. As a result, many patients do not receive most of the potential benefits that health care has to offer. Unfortunately, some of these missed opportunities result in recurrent decompensations of chronic illnesses, such as heart failure (HF). Within this context, many approaches have been developed to address health care delivery, including patient navigators, disease management programs, telehealth, home visits, remote monitoring, and more.1 While well intended, many of these interventions were based on anecdotes, local culture, and face validity. In addition, they are not benign, as interventions can be intrusive and the human resources involved are often expensive. In response, a science of outcomes research and delivery science has grown to evaluate routine care and the interventions designed to improve that care. In the HF context, largely due to Medicare payment policies, much of the focus over the past decade has been on hospitalizations, readmissions, and transitions of care.2 Although a substantial body of research exists on the topic, few data involve rigorously testing approaches using pragmatic randomized clinical trial designs. As a result, while we know a lot about the outcomes of patients with decompensated HF, we know little about how best to manage these patients. In this issue of JAMA Cardiology, Collins and colleagues3 report the findings of the multicenter randomized controlled Get With the Guidelines in Emergency Department Patients With HF (GUIDED-HF) trial. They enrolled 479 patients (63% African American) who presented with worsening HF (40% with preserved ejection fraction) to 1 of 15 geographically diverse emergency departments (EDs) and were discharged home without hospital admission. Those randomized to intervention received a home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching. At 90 days following ED discharge, a global rank primary outcome was assessed: cardiovascular death, unscheduled HF event (clinic visit, ED visit, and hospitalization), and change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) summary score. The main outcome was neutral: hazard ratio (HR), 0.90 (95% CI, 0.73-1.10). A secondary outcome of classic cardiovascular death or HF hospitalization was also neutral: 32% vs 36% (P = .21). The global ranking at 30-day was better for patients assigned to intervention (HR, 0.80; 95% CI, 0.65-0.99; P = .04), and 30-day KCCQ-12 SS was also higher (95% CI, 0.82-9.19; P = .02), but these were down the list of secondary outcomes to be tested, and the test of statistical significance was not adjusted for multiple comparisons. Despite the primary end point being negative, the GUIDED-HF investigators should be commended for carrying out a well-designed, large-scale trial addressing an important question. There are several take-aways for clinicians, policy makers, and health care organizations from this study. First, we need more trials such as GUIDED-HF to provide a framework for local health care delivery initiatives. Most of these initiatives are developed and tested in local, isolated settings, usually as small to moderate-sized quality improvement or process improvement projects. While this type of localized work is necessary and may provide some guidance to others on how to tackle a problem like worsening HF, it lacks scientific rigor. Therefore, the effectiveness is difficult to assess, and generalizability outside the environment in which it was carried out is relatively unknown, leaving each hospital to carry on with solutions that are of uncertain benefit. In contrast, the GUIDED-HF applied a standard approach in 15 different ED settings, thus providing important data on the challenges of designing an intervention for broad dissemination, the local needs for implementation, and the likely benefit of such effort. GUIDED-HF developed and then tested a health care delivery intervention grounded in close follow-up and self-care, but included a tailored discharge plan based on a patient’s preferences for and barriers to outpatient management. Long-term care management is not a simple daily pill or single procedure; interventions of this nature are contextualized, personalized, time-intensive, multidisciplinary, and multicomponent. They must be pragmatic by nature. Each community, hospital, and patient face different barriers when it comes to care of HF.4 We need trials such as GUIDED-HF to explore what can and cannot be standardized, as well as what core components do and do not work. Second, GUIDED-HF moved the transitional care discussion earlier into the course of worsening HF. Relatively few studies have focused on the care of patients presenting with worsening HF who are discharged home from the ED. Given the triaging nature of EDs, there are limitations in what can be easily be done to help patients transition back to the outpatient setting. Transitional care is further complicated by the relatively high proportion of patients presenting to the ED who are underinsured and who lack established ambulatory care with access within days of discharge. Given these challenges, the default is to admit most of these patients. GUIDED-HF deserves praise for challenging this paradigm. They enrolled a large proportion of vulnerable patients of non-White race, brief health literacy score less than 9, a national area deprivation index score greater than 85, and who use the ED as their main source of health care. Thus, GUIDED-HF, even while negative in its outcome assessment, draws attention to this population and area HF and will produce further publications on what they learned during conduct of the study. In addition, GUIDED-HF used a variety of methods to facilitate access with patients, including telehealth: 11% of home visits were completed via telehealth.3 Being able to access remote, disadvantaged, or vulnerable populations via telehealth is a novel opportunity to support these individuals, especially after an ED visit. The coronavirus disease 2019 pandemic has demonstrated the capacity of the system to conduct telemedicine visits, with an 80-fold increase in telehealth from April 2019 to April 2020.5 But telehealth also has the opportunity to exacerbate disparities if we do not provide disadvantaged populations with appropriate hardware, broadband access, and technological options.6 Despite only 11% of patients opting for a telehealth visit in the GUIDED-HF trial, the investigators noted the telehealth approach as an important alternative for patients who refused a home visit. We anticipate seeing an increased number telehealth or app-based interventions being offered, and we need to continue to test and refine these interventions to make them accessible, practical, effective, and equitable. In the end, interpreting this “negative” trial—and many pragmatic care delivery trials—raises important questions and adds nuance to the care we provide every day. Which individuals may best respond to this type of approach? What is the frequency of the intervention to provide the right dose? Was the content of the visits the right formulation? When a drug does not work, we move to a new compound, but when a constellation of logical care delivery processes applied across multiple institutions does not result in a significant improvement in outcomes, what do we discard and what do we maintain? It is these questions that we will continue to ask as more health care delivery interventions are developed and tested in an attempt to further our knowledge about how to stabilize patients with worsening HF and keep them healthy and at home. Only through iterative, rigorous testing of the health care processes we deliver every day can we turn a house of cards into something that provides high value and we can be proud to call our home. Back to top Article Information Corresponding Author: Larry A. Allen, MD, MHS, Division of Cardiology, University of Colorado School of Medicine, 12631 E 17th Ave, Academic Office 1, Ste 7019, Mailstop B130, Aurora, CO 80045 (larry.allen@cuanschutz.edu). Published Online: November 18, 2020. doi:10.1001/jamacardio.2020.5778 Conflict of Interest Disclosures: Dr Allen has received grant funding from the American Heart Association, National Institutes of Health, and Patient-Centered Outcomes Research Institute, and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. References 1. Albert NM, Barnason S, Deswal A, et al; American Heart Association Complex Cardiovascular Patient and Family Care Committee of the Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Transitions of care in heart failure: a scientific statement from the American Heart Association.  Circ Heart Fail. 2015;8(2):384-409. doi:10.1161/HHF.0000000000000006 PubMedGoogle ScholarCrossref 2. McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program.  Circulation. 2015;131(20):1796-1803. doi:10.1161/CIRCULATIONAHA.114.010270 PubMedGoogle ScholarCrossref 3. Collins SP, Liu D, Jenkins CA, et al. Effect of a self-care intervention on 90-day outcomes in patients with acute heart failure discharged from the emergency department: a randomized clinical trial.  JAMA Cardiol. Published online November 18, 2020 doi:10.1001/jamacardio.2020.5763Google Scholar 4. McCreight MS, Rabin BA, Glasgow RE, et al. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs.  Transl Behav Med. 2019;9(6):1002-1011. doi:10.1093/tbm/ibz085 PubMedGoogle ScholarCrossref 5. FAIR Health. Monthly telehealth regional tracker. Accessed September 4, 2020. https://www.fairhealth.org/states-by-the-numbers/telehealth 6. Eberly LA, Khatana SAM, Nathan AS, et al. Telemedicine outpatient cardiovascular care during the COVID-19 pandemic: bridging or opening the digital divide? Published online June 8, 2020. Circulation. doi:10.1161/CIRCULATIONAHA.120.048185 PubMedGoogle Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Cardiology American Medical Association

Mis-GUIDED—The Importance of Negative Trials of Health Care Delivery and Implementation Science

JAMA Cardiology , Volume 6 (2) – Feb 18, 2021

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American Medical Association
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Copyright 2020 American Medical Association. All Rights Reserved.
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2380-6583
eISSN
2380-6591
DOI
10.1001/jamacardio.2020.5778
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Abstract

Modern medicine is a glittering edifice of possibilities. But it has also become a house of cards. For the average patient, who has multiple chronic conditions playing out among a host of psychological and socioeconomic issues, navigating the health care system is challenging. For clinicians and institutions, designing and executing complex care plans has also become challenging. As a result, many patients do not receive most of the potential benefits that health care has to offer. Unfortunately, some of these missed opportunities result in recurrent decompensations of chronic illnesses, such as heart failure (HF). Within this context, many approaches have been developed to address health care delivery, including patient navigators, disease management programs, telehealth, home visits, remote monitoring, and more.1 While well intended, many of these interventions were based on anecdotes, local culture, and face validity. In addition, they are not benign, as interventions can be intrusive and the human resources involved are often expensive. In response, a science of outcomes research and delivery science has grown to evaluate routine care and the interventions designed to improve that care. In the HF context, largely due to Medicare payment policies, much of the focus over the past decade has been on hospitalizations, readmissions, and transitions of care.2 Although a substantial body of research exists on the topic, few data involve rigorously testing approaches using pragmatic randomized clinical trial designs. As a result, while we know a lot about the outcomes of patients with decompensated HF, we know little about how best to manage these patients. In this issue of JAMA Cardiology, Collins and colleagues3 report the findings of the multicenter randomized controlled Get With the Guidelines in Emergency Department Patients With HF (GUIDED-HF) trial. They enrolled 479 patients (63% African American) who presented with worsening HF (40% with preserved ejection fraction) to 1 of 15 geographically diverse emergency departments (EDs) and were discharged home without hospital admission. Those randomized to intervention received a home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching. At 90 days following ED discharge, a global rank primary outcome was assessed: cardiovascular death, unscheduled HF event (clinic visit, ED visit, and hospitalization), and change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) summary score. The main outcome was neutral: hazard ratio (HR), 0.90 (95% CI, 0.73-1.10). A secondary outcome of classic cardiovascular death or HF hospitalization was also neutral: 32% vs 36% (P = .21). The global ranking at 30-day was better for patients assigned to intervention (HR, 0.80; 95% CI, 0.65-0.99; P = .04), and 30-day KCCQ-12 SS was also higher (95% CI, 0.82-9.19; P = .02), but these were down the list of secondary outcomes to be tested, and the test of statistical significance was not adjusted for multiple comparisons. Despite the primary end point being negative, the GUIDED-HF investigators should be commended for carrying out a well-designed, large-scale trial addressing an important question. There are several take-aways for clinicians, policy makers, and health care organizations from this study. First, we need more trials such as GUIDED-HF to provide a framework for local health care delivery initiatives. Most of these initiatives are developed and tested in local, isolated settings, usually as small to moderate-sized quality improvement or process improvement projects. While this type of localized work is necessary and may provide some guidance to others on how to tackle a problem like worsening HF, it lacks scientific rigor. Therefore, the effectiveness is difficult to assess, and generalizability outside the environment in which it was carried out is relatively unknown, leaving each hospital to carry on with solutions that are of uncertain benefit. In contrast, the GUIDED-HF applied a standard approach in 15 different ED settings, thus providing important data on the challenges of designing an intervention for broad dissemination, the local needs for implementation, and the likely benefit of such effort. GUIDED-HF developed and then tested a health care delivery intervention grounded in close follow-up and self-care, but included a tailored discharge plan based on a patient’s preferences for and barriers to outpatient management. Long-term care management is not a simple daily pill or single procedure; interventions of this nature are contextualized, personalized, time-intensive, multidisciplinary, and multicomponent. They must be pragmatic by nature. Each community, hospital, and patient face different barriers when it comes to care of HF.4 We need trials such as GUIDED-HF to explore what can and cannot be standardized, as well as what core components do and do not work. Second, GUIDED-HF moved the transitional care discussion earlier into the course of worsening HF. Relatively few studies have focused on the care of patients presenting with worsening HF who are discharged home from the ED. Given the triaging nature of EDs, there are limitations in what can be easily be done to help patients transition back to the outpatient setting. Transitional care is further complicated by the relatively high proportion of patients presenting to the ED who are underinsured and who lack established ambulatory care with access within days of discharge. Given these challenges, the default is to admit most of these patients. GUIDED-HF deserves praise for challenging this paradigm. They enrolled a large proportion of vulnerable patients of non-White race, brief health literacy score less than 9, a national area deprivation index score greater than 85, and who use the ED as their main source of health care. Thus, GUIDED-HF, even while negative in its outcome assessment, draws attention to this population and area HF and will produce further publications on what they learned during conduct of the study. In addition, GUIDED-HF used a variety of methods to facilitate access with patients, including telehealth: 11% of home visits were completed via telehealth.3 Being able to access remote, disadvantaged, or vulnerable populations via telehealth is a novel opportunity to support these individuals, especially after an ED visit. The coronavirus disease 2019 pandemic has demonstrated the capacity of the system to conduct telemedicine visits, with an 80-fold increase in telehealth from April 2019 to April 2020.5 But telehealth also has the opportunity to exacerbate disparities if we do not provide disadvantaged populations with appropriate hardware, broadband access, and technological options.6 Despite only 11% of patients opting for a telehealth visit in the GUIDED-HF trial, the investigators noted the telehealth approach as an important alternative for patients who refused a home visit. We anticipate seeing an increased number telehealth or app-based interventions being offered, and we need to continue to test and refine these interventions to make them accessible, practical, effective, and equitable. In the end, interpreting this “negative” trial—and many pragmatic care delivery trials—raises important questions and adds nuance to the care we provide every day. Which individuals may best respond to this type of approach? What is the frequency of the intervention to provide the right dose? Was the content of the visits the right formulation? When a drug does not work, we move to a new compound, but when a constellation of logical care delivery processes applied across multiple institutions does not result in a significant improvement in outcomes, what do we discard and what do we maintain? It is these questions that we will continue to ask as more health care delivery interventions are developed and tested in an attempt to further our knowledge about how to stabilize patients with worsening HF and keep them healthy and at home. Only through iterative, rigorous testing of the health care processes we deliver every day can we turn a house of cards into something that provides high value and we can be proud to call our home. Back to top Article Information Corresponding Author: Larry A. Allen, MD, MHS, Division of Cardiology, University of Colorado School of Medicine, 12631 E 17th Ave, Academic Office 1, Ste 7019, Mailstop B130, Aurora, CO 80045 (larry.allen@cuanschutz.edu). Published Online: November 18, 2020. doi:10.1001/jamacardio.2020.5778 Conflict of Interest Disclosures: Dr Allen has received grant funding from the American Heart Association, National Institutes of Health, and Patient-Centered Outcomes Research Institute, and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. References 1. Albert NM, Barnason S, Deswal A, et al; American Heart Association Complex Cardiovascular Patient and Family Care Committee of the Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Transitions of care in heart failure: a scientific statement from the American Heart Association.  Circ Heart Fail. 2015;8(2):384-409. doi:10.1161/HHF.0000000000000006 PubMedGoogle ScholarCrossref 2. McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program.  Circulation. 2015;131(20):1796-1803. doi:10.1161/CIRCULATIONAHA.114.010270 PubMedGoogle ScholarCrossref 3. Collins SP, Liu D, Jenkins CA, et al. Effect of a self-care intervention on 90-day outcomes in patients with acute heart failure discharged from the emergency department: a randomized clinical trial.  JAMA Cardiol. Published online November 18, 2020 doi:10.1001/jamacardio.2020.5763Google Scholar 4. McCreight MS, Rabin BA, Glasgow RE, et al. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs.  Transl Behav Med. 2019;9(6):1002-1011. doi:10.1093/tbm/ibz085 PubMedGoogle ScholarCrossref 5. FAIR Health. Monthly telehealth regional tracker. Accessed September 4, 2020. https://www.fairhealth.org/states-by-the-numbers/telehealth 6. Eberly LA, Khatana SAM, Nathan AS, et al. Telemedicine outpatient cardiovascular care during the COVID-19 pandemic: bridging or opening the digital divide? Published online June 8, 2020. Circulation. doi:10.1161/CIRCULATIONAHA.120.048185 PubMedGoogle Scholar

Journal

JAMA CardiologyAmerican Medical Association

Published: Feb 18, 2021

Keywords: delivery of health care,negative studies,implementation science,heart failure

References