Patient Perspectives on a Polypill Strategy for Heart Failure With Reduced Ejection Fraction: A Convergent-Parallel Mixed Methods Study Embedded in a Randomized Clinical Trial.

Abstract

Background: Heart failure with reduced ejection fraction guideline-directed medical therapy remains underused, particularly in socioeconomically disadvantaged populations. It has been proposed that the use of combination pills (polypills) may facilitate prescribing of guideline-directed medical therapy and increase adherence. Understanding patient perspectives on implementation barriers and facilitators to the use of polypills is needed for developing effective strategies.

Methods: A convergent, parallel, mixed-methods study was conducted with participants who participated in a phase II randomized controlled trial of a heart failure with reduced ejection fraction polypill (POLY HF) in Dallas, TX. Six focus groups were conducted with participants from both polypill and usual care arms, followed by brief surveys. Qualitative data were analyzed using directed content analysis organized by a socioecological framework to identify barriers and facilitators across individual, interpersonal, and systems levels. Descriptive statistics characterized medication burden and polypill preferences.

Results: Study participants (n=41) included trial participants (n=36, mean 53 years, 53% Black race, 39% Hispanic) and caregivers (n=5). Quantitative data revealed substantial medication burden, with 58% taking ≥6 medications and 50.0% reporting missed doses, primarily due to forgetting (44%). 88.6% expressed interest in a polypill approach, and 83% believed it would improve adherence. Qualitative analysis identified multilevel implementation barriers and facilitators. Individual-level barriers included pill size concerns and uncertainty about polypill contents, while facilitators encompassed reduced pill burden, psychological benefits of taking fewer medications, and perceived health improvements. Interpersonal facilitators included caregiver enthusiasm for simplified medication management and strong provider trust. Systems-level barriers centered on cost concerns, while institutional trust facilitated acceptance. Mixed-methods integration revealed convergent findings. Quantitative medication burden aligned with qualitative themes of regimen complexity, while high quantitative interest in polypills was contextualized by practical implementation considerations regarding formulation and delivery.

Conclusions: In socioeconomically disadvantaged patients with heart failure with reduced ejection fraction, a polypill strategy demonstrated strong patient acceptability, supporting further implementation research.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04633005.