Integrating Out-of-Pocket Costs Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction: A Stepped-Wedge Trial (POCKET-COST-HF).

Background: Guideline-directed medical therapy for heart failure (HF) with reduced ejection fraction can entail high out-of-pocket (OOP) costs, prompting concerns about financial toxicity and access. OOP costs are generally unavailable during encounters. This trial assessed the impact of providing patient-specific OOP costs to patients and clinicians.

Methods: This trial was conducted between June 2021 and August 2023 at 6 clinics in 2 health systems using a stepped-wedge, clinic-level cluster-randomized design. Adult patients with HF with reduced ejection fraction (left ventricular ejection fraction ≤40%) were enrolled. The intervention was built upon the EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) checklist of approved HF with reduced ejection fraction medications. Patients and clinicians received this checklist with (intervention) or without (control) patient-specific OOP cost estimates for higher-cost medications at the time of encounter. Estimates were obtained by providing pharmacy benefit information to a financial navigation firm. Encounters were audio-recorded, and patients were surveyed 2 weeks later. The primary outcome was cost-informed decision-making, defined by mentioning HF medication cost during the encounter. The primary analysis used a generalized linear mixed model. Secondary outcomes were assessed via transcript subcoding and analysis of survey responses.

Results: Demographic characteristics of 247 patients (mean age, 62.9 years; 29.5% female; 26.3% Black; and 3.2% Hispanic/LatinX) treated by 39 clinicians in intervention and control periods were similar. In the primary model, the rate of cost-informed decision-making was higher in the intervention group than the control group (68% versus 49%; P=0.021). Baseline rates of cost discussions and the impact of the intervention varied across sites. When cost discussions were present, fewer discussions in the intervention group involved contingency plans to address potential costs (16.5% versus 31.9%; P=0.028). Most other secondary outcomes were not significantly different.

Conclusions: Disclosing comprehensive OOP medication costs to patients with HF with reduced ejection fraction increased cost-informed decision-making. Further work is needed to optimize implementation and assess the impact on medication choices and adherence.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04793880.