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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.)

Objective: Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study., Setting: A large tertiary care medical centre in Chicago., Participants: Low-income patients (80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention., Conclusions: This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Purpose: Heart failure (HF) is associated with poor health-related quality of life (HRQOL). The purpose of our study is to determine the effect of a self-management intervention on HRQOL domains across time, overall, and in prespecified demographic, clinical, and psychosocial subgroups of HF patients., Methods: HART was a single-center, multi-hospital randomized trial. Patients (n = 902) were randomized either to a self-management intervention with provision of HF educational information or an enhanced education control group which received the same HF educational materials. HRQOL was measured by the Quality of Life Index, Cardiac Version, modified, and the Medical Outcomes Study 36-item Short-Form Health Survey physical functioning scale. Analyses included descriptive statistics and mixed-effects regression models., Results: In general, overall, study participants' HRQOL improved over time. However, no significant differences in HRQOL domain were detected between treatment groups at baseline or across time (p > 0.05). Subgroup analyses demonstrated no differences by treatment arm for change in HRQOL from baseline to 3 years later., Conclusions: We conclude that in our cohort of patients, the self-management intervention had no benefit over enhanced education in improving domains of HRQOL and HRQOL for specified HF subgroups.

Context: Motivating patients with heart failure to adhere to medical advice has not translated into clinical benefit, but past trials have had methodological limitations., Objective: To determine the value of self-management counseling plus heart failure education, compared with heart failure education alone, for the primary end point of death or heart failure hospitalization., Design, Setting, and Patients: The Heart Failure Adherence and Retention Trial (HART), a single-center, multiple-hospital, partially blinded behavioral efficacy randomized controlled trial involving 902 patients with mild to moderate heart failure and reduced or preserved systolic function, randomized from the Chicago metropolitan area between October 2001 and October 2004 and undergoing follow-up for 2 to 3 subsequent years., Interventions: All patients were offered 18 contacts and 18 heart failure educational tip sheets during the course of 1 year. Patients randomized to the education group received tip sheets in the mail and telephone calls to check comprehension. Patients randomized to the self-management group received tip sheets in groups and were taught self-management skills to implement the advice., Main Outcome Measure: Death or heart failure hospitalization during a median of 2.56 years of follow-up., Results: Patients were representative of typical clinical populations (mean age, 63.6 years; 47% women, 40% racial/ethnic minority, 52% with annual family income less than $30,000, and 23% with preserved systolic function). The rate of the primary end point in the self-management group was no different from that in the education group (163 [40.1%)] vs 171 [41.2%], respectively; odds ratio, 0.95 [95% confidence interval, 0.72-1.26]). There were no significant differences on any secondary end points, including death, heart failure hospitalization, all-cause hospitalization, or quality of life., Conclusions: Compared with an enhanced educational intervention alone, the addition of self-management counseling did not reduce death or heart failure hospitalization in patients with mild to moderate heart failure., Trial Registration: clinicaltrials.gov Identifier: NCT00018005.

Background: Heart failure (HF) is increasing in prevalence and is associated with prolonged morbidity, repeat hospitalizations, and high costs. Drug therapies and lifestyle changes can reduce hospitalizations, but nonadherence is high, ranging from 30% to 80%. There is an urgent need to identify cost-effective ways to improve adherence and reduce hospitalizations., Trial Design: The Heart Failure Adherence and Retention Trial (HART) evaluated the benefit of patient self-management (SM) skills training in combination with HF education, over HF education alone, on the composite end points of death/HF hospitalizations and death/all-cause hospitalizations in patients with mild to moderate systolic or diastolic dysfunction. Secondary end points included progression of HF, quality of life, adherence to drug and lifestyle regimens, and psychosocial function. The HART cohort was composed of 902 patients including 47% women, 40% minorities, and 23% with diastolic dysfunction. After a baseline examination, patients were randomized to SM or education control, received 18 treatment contacts over 1 year, annual follow-ups, and 3-month phone calls to assess primary end points. Self-management treatment was conducted in small groups and aimed to activate the patient to implement HF education through training in problem-solving and 5 SM skills. The education control received HF education in the mail followed by a phone call to check comprehension., Conclusions: The significance of HART lies in its ability to determine the clinical value of activating the patient to collaborate in his or her care. Support for the trial hypotheses would encourage interdisciplinary HF treatment, drawing on an evidence base not only from medicine but also from behavioral medicine.

The Heart Failure Adherence and Retention Trial (HART) provided an opportunity to determine adherence to evidence-based guidelines (EBG) in patients with heart failure (HF). Ten hospitals were the source of 692 patients with HF (EF < 40%). Physicians of patients with HF were classified as adherent to EBG if the patient chart audit showed they were on a beta-blocker, ACE-inhibitor (ACE-I), or angiotensin receptor blocker (ARB). Patients were classified as adherent to EBG if MEMS pill caps were used appropriately more than 80% of the time. Sixty-three percent of physicians prescribed evidence-based medications that were adherent to clinical practice guidelines. New York Heart Association (NYHA) III patients were less likely to be adherent ( P < 0.001), as were those with renal disease ( P < 0.001) and asthmatics ( P < 0.001). Nonadherent physicians were less likely to treat patients with beta-blockers (39% vs 98%, P < 0.001) and ACE-I or ARBs (71% vs 98% P < 0.001). Thirty-seven percent of patients prescribed evidence-based therapy failed to use the MEMS pill cap bottles appropriately and were more likely a minority or higher NYHA class. Adherence to evidence-based therapy is less than optimal in HF patients based on a combination of both physician and patient nonadherence. ©2011 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]