Developing a Multilevel Polypill Implementation Bundle for Patients With Heart Failure With Reduced Ejection Fraction

Background: A polypill that contains multiple guideline-directed medical therapies for heart failure with reduced ejection fraction (HFrEF) has been proposed to improve HFrEF outcomes. The factors affecting implementation of a polypill-based strategy for HFrEF are unknown. Objectives: This study aims to identify determinants that could affect a polypill-based strategy for HFrEF, design a multilevel HFrEF polypill implementation bundle, and illustrate how the bundle could improve outcomes. Methods: From April to December 2023, we conducted a convergent parallel mixed methods study at Washington University in St. Louis and the University of California-San Francisco to gather patient (N = 9) and provider (N = 22) perspectives on a polypill-based approach to HFrEF care guided by the Consolidated Framework for Implementation Research v2.0. We then used the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change Matching Tool to select strategies for a multilevel implementation bundle and mechanism mapping to elucidate how the bundle could improve patient outcomes. Results: Stakeholder interviews revealed four themes that affect implementation of a polypill-based approach to HFrEF. The current state of HFrEF care was the organizing theme, influenced by 3 additional themes: awareness of new innovations, assessing innovation appropriateness, and building competency in HFrEF care. Based on these themes, we developed a multilevel HFrEF polypill implementation bundle with 7 domains and illustrate how the bundle could improve outcomes with a directed acyclic graph. Conclusions: This study illustrates the development of a multilevel HFrEF polypill implementation bundle that can be further tailored to improve HFrEF care in undertreated populations globally.