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Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF - 05/02/20

Doi : 10.1016/j.ahj.2019.09.012 
Adam D. DeVore, MD, MHS a, b, , Bradi B. Granger, PhD, RN c, Gregg C. Fonarow, MD d, Hussein R. Al-Khalidi, PhD a, Nancy M. Albert, PhD e, Eldrin F. Lewis, MD, MPH f, Javed Butler, MD, MPH g, Ileana L. Piña, MD, MPH h, Paul A. Heidenreich, MD, MS i, Larry A. Allen, MD, MHS j, Cyde W. Yancy, MD k, Lauren B. Cooper, MD, MHS l, G. Michael Felker, MD, MHS a, b, Lisa A. Kaltenbach, MS a, A. Thomas McRae, MD m, David E. Lanfear, MD, MS n, Robert W. Harrison, MD a, b, Robb D. Kociol, MD o, Maghee Disch, MSN, RN p, Dan Ariely, PhD q, Julie M. Miller, PhD, MSPH q, Christopher B. Granger, MD a, b, Adrian F. Hernandez, MD, MHS a, b
a Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 
b Department of Medicine, Duke University School of Medicine, Durham, NC 
c Duke University School of Nursing, Durham, NC 
d Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA 
e Cleveland Clinic, Cleveland, OH 
f Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA 
g Department of Medicine, University of Mississippi Medical Center, Jackson, MS 
h Wayne State University and Detroit Medical Center, Detroit, MI 
i Division of Cardiology, Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA 
j Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO 
k Division of Cardiology, Northwestern University, Chicago, IL 
l Department of Heart Failure and Transplantation, Inova Heart and Vascular Institute, Falls Church, VA 
m Centennial Heart, Nasheville, TN 
n Department of Medicine, Cardiovascular Division, and Henry Ford Heart and Vascular Institute, Henry Ford Hospital, Detroit, MI 
o Beth Israel Deaconess Medical Center, Boston, MA 
p American College of Cardiology 
q Center for Advanced Hindsight, Duke University, Durham, NC 

Reprint requests: Adam D. DeVore, MD, MHS, Duke Clinical Research Institute, 200 Morris Street, 6318, Durham, NC, 27701, USA.Duke Clinical Research Institute200 Morris Street, 6318DurhamNC27701USA

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.

Le texte complet de cet article est disponible en PDF.

Plan


 Shannon Dunlay, MD, MS, MD served as guest editor for this article.
 RCT# NCT03035474
 Trial Registration: clinicaltrials.gov Identifier: NCT03035474.


© 2019  Publié par Elsevier Masson SAS.
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Vol 220

P. 41-50 - février 2020 Retour au numéro
Article précédent Article précédent
  • Variations in stepped-wedge cluster randomized trial design: Insights from the Patient-Centered Care Transitions in Heart Failure trial
  • Rudy R. Unni, Shun Fu Lee, Lehana Thabane, Stuart Connolly, Harriette GC Van Spall
| Article suivant Article suivant
  • PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study in patients with atrial fibrillation: Rationale, design and methods
  • MT Barrio-Lopez, M Ruiz-Canela, P Ramos, L Tercedor, JL Ibañez Criado, M Ortiz, L Goni, A Ibañez Criado, R Macías-Ruiz, I García-Bolao, MA Martínez-González, J Almendral

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