Design, Characteristics, and Implementation of the Financial Support for Low-Income Patients with Heart Failure Trial.

backgroundPatients with heart failure (HF) with socioeconomic hardship have poor medication adherence and worse patient outcomes. Whether an early postdischarge financial support intervention can improve care behaviors and outcomes among socioeconomically disadvantaged populations is unclear.

objectivesTo describe the design, socioeconomic eligibility framework, therapeutic drug monitoring methodology, and baseline characteristics of the FUND-HF trial, a pilot randomized controlled trial evaluating the feasibility and effect of early postdischarge financial support among low-income patients with HF with reduced ejection fraction. The primary clinical outcomes are reported in a companion Brief Report.

methodsIn this pilot randomized controlled trial (NCT05928026), adults hospitalized for acute HF with income <130% federal poverty limit and difficulty paying bills with ≥1 additional socioeconomic need were randomized within 14 days of discharge 1:1 to early financial support ($500 debit card) vs control ($500 at 30-day follow-up). Key outcomes were medication adherence assessed by therapeutic drug monitoring, expressed as percent of tested cardiac drugs with detectable serum levels and categorized as complete/partial/none, assessed overall and for HF guideline-directed medical therapy with available assays (metoprolol, spironolactone) and the Kansas City Cardiomyopathy Questionnaire at 1 month. Data on 30-day all-cause hospitalizations and outpatient visit attendance were also collected.

resultsOf the 153 randomized participants (n = 76 financial support; n = 77 control; mean 53 y, 76% male, 73% Black; mean ejection fraction 26 ± 9%), 140 completed 1-month follow-up. Participants had median monthly income of $600 (IQR 0-1179), with 76% reporting cost-related medication non-adherence at baseline. On average, participants had 5 identified socioeconomic domain needs. Housing instability was reported by 50% of participants, while 85% reported food insecurity and 65% reported transportation barriers. 81% of participants were unemployed or retired. Baseline characteristics were well balanced between groups except for numerically higher median monthly income and lower mineralocorticoid receptor antagonist/sodium-glucose cotransporter-2 inhibitor prescription in the financial support group.

conclusionsThe FUND-HF pilot trial successfully enrolled a deeply socioeconomically disadvantaged HF with reduced ejection fraction population using a multidomain social determinants of health eligibility framework with comprehensive socioeconomic phenotyping across multiple domains. This pilot design and implementation framework provides a practical template for future larger trials targeting economic barriers in cardiovascular populations. The clinical findings of this pilot trial are presented in the companion report.