Can a hospital and postdischarge intervention focused on education on heart failure care as well as audit and feedback on care processes improve postdischarge outcomes and quality of care for patients with heart failure with reduced ejection fraction?
In this cluster randomized trial that included 5647 patients and 161 hospitals, patients in hospitals randomized to the quality improvement intervention compared with usual care had a rate of rehospitalization or death of 38.6% vs 39.2% and change in quality-of-care scores of 2.3% vs −1.0%, respectively; neither comparison was statistically significant.
A hospital and postdischarge quality improvement intervention did not result in better clinical outcomes or measure of quality of care for patients with heart failure with reduced ejection fraction.
Adoption of guideline-directed medical therapy for patients with heart failure is variable. Interventions to improve guideline-directed medical therapy have failed to consistently achieve target metrics, and limited data exist to inform efforts to improve heart failure quality of care.
To evaluate the effect of a hospital and postdischarge quality improvement intervention compared with usual care on heart failure outcomes and care.
Design, Setting, and Participants
This cluster randomized clinical trial was conducted at 161 US hospitals and included 5647 patients (2675 intervention vs 2972 usual care) followed up after a hospital discharge for acute heart failure with reduced ejection fraction (HFrEF). The trial was performed from 2017 to 2020, and the date of final follow-up was August 31, 2020.
Hospitals (n = 82) randomized to a hospital and postdischarge quality improvement intervention received regular education of clinicians by a trained group of heart failure and quality improvement experts and audit and feedback on heart failure process measures (eg, use of guideline-directed medical therapy for HFrEF) and outcomes. Hospitals (n = 79) randomized to usual care received access to a generalized heart failure education website.
Main Outcomes and Measures
The coprimary outcomes were a composite of first heart failure rehospitalization or all-cause mortality and change in an opportunity-based composite score for heart failure quality (percentage of recommendations followed).
Among 5647 patients (mean age, 63 years; 33% women; 38% Black; 87% chronic heart failure; 49% recent heart failure hospitalization), vital status was known for 5636 (99.8%). Heart failure rehospitalization or all-cause mortality occurred in 38.6% in the intervention group vs 39.2% in usual care (adjusted hazard ratio, 0.92 [95% CI, 0.81 to 1.05). The baseline quality-of-care score was 42.1% vs 45.5%, respectively, and the change from baseline to follow-up was 2.3% vs −1.0% (difference, 3.3% [95% CI, −0.8% to 7.3%]), with no significant difference between the 2 groups in the odds of achieving a higher composite quality score at last follow-up (adjusted odds ratio, 1.06 [95% CI, 0.93 to 1.21]).
Conclusions and Relevance
Among patients with HFrEF in hospitals randomized to a hospital and postdischarge quality improvement intervention vs usual care, there was no significant difference in time to first heart failure rehospitalization or death, or in change in a composite heart failure quality-of-care score.
ClinicalTrials.gov Identifier: NCT03035474
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Adam D. DeVore, MD, MHS, Duke Clinical Research Institute, 200 Morris St, 6318, Durham, NC 27701 (firstname.lastname@example.org).
Accepted for Publication: May 17, 2021.
Author Contributions: Dr DeVore had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: DeVore, B. Granger, Fonarow, Al-Khalidi, Albert, Lewis, Butler, Piña, Allen, Yancy, Cooper, Felker, Kaltenbach, McRae, Disch, Ariely, Miller, C. Granger, Hernandez.
Acquisition, analysis, or interpretation of data: DeVore, B. Granger, Fonarow, Al-Khalidi, Lewis, Butler, Piña, Allen, Cooper, Felker, Kaltenbach, Lanfear, Harrison, Disch, Miller, C. Granger, Hernandez.
Drafting of the manuscript: DeVore, B. Granger, Al-Khalidi, Butler, Kaltenbach, Lanfear, Ariely.
Critical revision of the manuscript for important intellectual content: B. Granger, Fonarow, Al-Khalidi, Albert, Lewis, Butler, Piña, Allen, Yancy, Cooper, Felker, McRae, Lanfear, Harrison, Disch, Miller, C. Granger, Hernandez.
Statistical analysis: DeVore, Al-Khalidi, Kaltenbach, Miller.
Obtained funding: DeVore, Fonarow, Felker, Hernandez.
Administrative, technical, or material support: B. Granger, Butler, Allen, Felker, Kaltenbach, Lanfear, Harrison, Miller, Hernandez.
Supervision: B. Granger, Fonarow, Allen, Yancy, Felker, Disch, Ariely, Hernandez.
Conflict of Interest Disclosures: Dr Fonarow reported receiving personal fees from Novartis, Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis. Dr Al-Khalidi reported receiving grants from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute, and Mayo Clinic; serving on an NIH data and safety monitoring board; and receiving personal fees from Medpace Inc. Dr Lewis reported receiving personal fees from Amgen and Dal-Cor. Dr Butler reported receiving consulting fees from Novartis, Amgen, Array, AstraZeneca, American Regent, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceutical, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, NovoNordisk, Relypsa, Roche, Sanofi, V-Wave Limited, and Vifor. Dr Allen reported receiving grants from American Heart Association, NIH, and Patient-Centered Outcomes Research Institute and receiving personal fees from Amgen, ACI Clinical, Boston Scientific, Cytokinetics, Novartis, Circulation: Heart Failure, and UpToDate. Dr Yancy reported that his spouse is employed by Abbott Labs Inc. Dr Cooper reported receiving grants from Abbott and receiving personal fees from AstraZeneca. Dr Felker reported receiving personal fees from Amgen, Cytokinetics, Bristol Myers Squibb, Medtronic, Abbott, American Reagent, Boehringer-Ingelheim, Reprieve, Sequana, Siemens, EBR Systems, LivaNova, and V-Wave and receiving grants from Amgen, and Cytotkinetics. Dr Lanfear reported receiving personal fees from the Duke Clinical Research Institute steering committee for CONNECT-HF; receiving personal fees from Amgen, Janssen, Novartis (events adjudication for RELAXHF2), Ortho Diagnostics, Abbott Diagnostics, Abiomed, Martin Pharmaceuticals, Gore Consulting, and Duke Clinical Research Institute (Novartis, Akros, Amgen trial steering committees); receiving grants from Amgen, Bayer Clinical, Janssen, and Critical Diagnostics; receiving nonfinancial support from Somalogic Collaborative, holding stock options in Hridaya (small startup, no current value); and holding a patent for Polygenic Score for Cardiac Heart Failure Polygenic predictor of β-blocker response in heart failure (PCT/US20/50602) issued (no license or royalties). Dr C. Granger reported receiving personal fees from Pfizer/Bristol Myers Squibb and AstraZeneca and all conflicts of interest listed at https://dcri.org/about-us/conflict-of-interest/. Dr Hernandez reported receiving personal fees from AstraZeneca, Amgen, Bayer, Boehringer Ingelheim, Boston Scientific, Cytokinetics, Relypsa, Merck, Myokardia, and Bristol Myers Squibb and receiving grants from American Regent. No other disclosures were reported.
Funding/Support: The trial was funded by Novartis Pharmaceuticals Corporation through an investigator-initiated trial program (CLCZ696BUS05T).
Role of the Funder/Sponsor: Novartis Pharmaceuticals Corporation had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank the staff members from the sites and the patients who participated in this study, as well as the members of the “Cardi-Yacks” patient advisory panel.
Data Sharing Statement: See Supplement 3.
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