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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) ST-Segment Elevation Myocardial Infarction Patients in the Coronary Care Unit Is it Time to Break Old Habits? Association of preoperative glucose concentration with myocardial injury and death after non-cardiac surgery (GlucoVISION): a prospective cohort study Prognostic Effect and Longitudinal Hemodynamic Assessment of Borderline Pulmonary Hypertension Screening for Atrial Fibrillation With ECG: USPSTF Recommendation Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Prior Cerebrovascular Disease: Results From the EXCEL Trial Quality of Life after Everolimus-Eluting Stents or Bypass Surgery for Treatment of Left Main Disease Outcomes after drug-coated balloon treatment for patients with calcified coronary lesions

Original Research2018 Jan;195:139-150.

JOURNAL:Am Heart J. Article Link

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

Mangla A, Doukky R, Powell LH et al. Keywords: adherence; congestive heart failure

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.

Copyright © 2017 Elsevier Inc. All rights reserved.