Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF

Adam D. DeVore*, Bradi B. Granger, Gregg C. Fonarow, Hussein R. Al-Khalidi, Nancy M. Albert, Eldrin F. Lewis, Javed Butler, Ileana L. Piña, Paul A. Heidenreich, Larry A. Allen, Cyde W. Yancy, Lauren B. Cooper, G. Michael Felker, Lisa A. Kaltenbach, A. Thomas McRae, David E. Lanfear, Robert W. Harrison, Robb D. Kociol, Maghee Disch, Dan ArielyJulie M. Miller, Christopher B. Granger, Adrian F. Hernandez

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

Abstract

Many therapies have been shown to improve outcomes for patients with heart failure (HF) in controlled settings, but there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF study is a prospective, cluster-randomized trial of 161 hospitals in the United States with a 2×2 factorial design. The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective). The hospital and post-discharge intervention includes audit and feedback on HF clinical process measures and outcomes for patients with HF with reduced ejection fraction (HFrEF) paired with education to sites and clinicians by a trained, nationally representative group of HF and quality improvement experts. The patient-level digital intervention is an optional ancillary study and includes a mobile application and behavioral tools that are intended to facilitate improved use of guideline-directed recommendations for self-monitoring and self-management of activity and medications for HFrEF. The effects of the interventions will be measured through an opportunity-based composite score on quality and time-to-first HF readmission or death among patients with HFrEF who present to study hospitals with acute HF and who consent to participate. The CONNECT-HF study is evaluating approaches for implementing HF guideline recommendations into practice and is one of the largest HF implementation science trials performed to date.

Original languageEnglish (US)
Pages (from-to)41-50
Number of pages10
JournalAmerican heart journal
Volume220
DOIs
StatePublished - Feb 2020

Funding

The CONNECT-HF study is funded by Novartis Pharmaceuticals Corporation (East Hanover, NJ) through an investigator-initiated trial program (CLCZ696BUS05T). The following relationships exist related to this presentation: Adam DeVore receives research funding from AstraZeneca, Amgen, the American Heart Association, Bayer, Luitpold Pharmaceuticals, the NHLBI, PCORI and Novartis, and consulting with AstraZeneca, Mardil Medical, Novartis and Procyrion. Gregg Fonarow reports consulting for Abbott, Amgen, Bayer, Janssen, Medtronic, and Novartis. Nancy Albert reports consulting for Novartis. Eldrin Lewis receives research funding from Novartis, Merck, Sanofi AstraZeneca and receives consulting from Novartis, Merck, and Dal-Cor. Javed Butler: reports research support from the NIH, PCORI, and the European Union; and serves as a consultant for Amgen, Array, Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squib, CVRx, G3 Pharmaceutical, Innolife, Janssen, Luitpold, Medtronic, Merck, Novartis, Relypsa, SC Pharma, and Vifor, Larry Allen receives research funding from NIH, PCORI, and AHA, and consulting fees from ACI Clinical, Amgen/Cytokinetics, and Boston Scientific. Lauren Cooper reports receiving research funding from Abbott. Dr Felker has received research grants from NHLBI, American Heart Association, Amgen, Merck, Cytokinetics, and Roche Diagnostics; he has acted as a consultant to Novartis, Amgen, BMS, Medtronic, Cardionomic, Relypsa, V-Wave, Myokardia, Innolife, EBR Systems, Arena, Abbott, Sphingotec, Roche Diagnostics, Alnylam, LivaNova, Rocket Pharma, and SC Pharma. David E. Lanfear reports research funding from Amgen, Bayer, the NHLBI, Novartis, and Critical Diagnostics, and is a consultant to Amgen, Abbot Diagnostics, Abiomed, Ortho Diagnostics, Janssen, Hridaya, and the Duke Clinical Research Institute (Akros). Adrian Hernandez: reports research funding from American Regent, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Merck, Novartis, Verily, and consulting with AstraZeneca, Bayer, Boehringer-Ingelheim, Boston Scientific, Merck and Novartis Appendix A

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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