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Design of a bilevel clinical trial targeting adherence in heart failure patients and their providers: The Congestive Heart Failure Adherence Redesign Trial (CHART) - 09/12/17

Doi : 10.1016/j.ahj.2017.09.016 
Ashvarya Mangla, MD a, b, 1, Rami Doukky, MD, MSc a, b, c, , 1 , DeJuran Richardson, PhD a, d, Elizabeth F. Avery, MS a, Rebecca Dawar, MPH a, James E. Calvin, MD, MBA e, Lynda H. Powell, PhD a
a Department of Preventive Medicine, Rush University Medical Center, Chicago, IL 
b Division of Cardiology, Medicine, Rush University Medical Center, Chicago, IL 
c Division of Cardiology, Cook County Health and Hospitals System, Chicago, IL 
d Department of Mathematics and Computer Science, Lake Forest College, Lake Forest, IL 
e Department of Medicine, Western University, London, ON, Canada 

Reprint requests: Rami Doukky, MD, MSc, John H. Stroger, Jr Hospital of Cook County, Division of Cardiology, 1901 W Harrison St, Chicago, IL 60612.John H. Stroger, Jr Hospital of Cook CountyDivision of Cardiology1901 W Harrison StChicagoIL60612

Abstract

Background

Socioeconomically disadvantaged patients are at an increased risk for adverse heart failure (HF) outcomes based upon nonadherence to medications and diet. Physicians are also suboptimally adherent to prescribing evidence-based therapy for HF.

Methods

Congestive Heart Failure Adherence Redesign Trial (CHART) (NCT01698242) is a multicenter, bilevel, cluster randomized behavioral efficacy trial designed to assess the impact of intervening simultaneously on physicians and their socioeconomically disadvantaged patients (annual income <$30,000) having HF with reduced ejection fraction. Treatment arm physicians received individualized feedback on their adherence to prescribing evidence-based therapy. Their patients received weekly home visits from community health workers aimed at promoting understanding of HF and integrating adherence into daily life. Control arm physicians received regular updates on advances in HF management, and patients received monthly HF educational tip sheets produced by the American Heart Association. The primary outcome was all-cause hospital days over 30 months.

Results

A total of 72 physicians (treatment, 35; control, 37) and their 320 patients (treatment, 157; control, 163) were recruited within 2 years. Randomization of physicians with all of their patients being assigned to the same arm was feasible and did not compromise the comparability of patients by arm. Using 5 recruiting hospitals located within disadvantaged neighborhoods produced a cohort that was primarily African American and representative of low-income urban patients with HF with reduced ejection fraction.

Conclusion

CHART will determine the value of intervening on low adherence simultaneously in physicians and their socioeconomically disadvantaged patients in reducing all-cause hospitalization days.

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Plan


 Funding: Funded by the National Heart, Lung, and Blood Institute, grant 1P50HL105189-01, as part of the Rush Center for Urban Health Equity (Chicago, IL).
 Conflicts of interest: Rami Doukky receives research grants from Astellas Pharma (Northbrook, IL) and served on an advisory board for Astellas Pharma. The other authors have nothing to disclose.
 RCT# NCT01698242


© 2017  Elsevier Inc. Tous droits réservés.
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Vol 195

P. 139-150 - janvier 2018 Retour au numéro
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