Pragmatic implementation science to assess lipid optimization in peripheral artery disease: Design and conduct of the randomized optimize PAD-1 trial

ABSTRACT

Background: Underutilization of proven therapies in peripheral artery disease (PAD) remains a critical problem. Implementation science aims to improve this, but few trials exist. We describe a randomized trial designed with pragmatic elements in PAD patients. Method(s) OPTIMIZE PAD-1 was designed to evaluate the efficacy of a multidisciplinary vascular care team using an intensive lipid reduction program in PAD patients versus usual care. The primary endpoint is low density lipoprotein-cholesterol (LDL-C) reduction at 12 months. A second objective is to assess the impact of a structured quality assurance program (EQuIP) on variability in 6-minute walk test (6MWT) distance. Due to COVID-19, pragmatic aspects were introduced, including virtual consent/recruitment, home-based subject conducted lab testing, and virtually monitored homebased 6MWT. Result(s) A total of 114 subjects with PAD were recruited over ~18 months at the University of Colorado and randomized to algorithm-driven lipid management by a multidisciplinary vascular care team with pharmacist support or to usual care (Figure). Subjects were also randomized to 6MWT conducted by site versus EQuIP staff. Potential participants and clinical events during follow up were identified via electronic medical records. Adjustments to enable remote study conduct were successfully implemented. Conclusion(s) Pragmatic randomized trials in PAD patients are feasible to strengthen implementation science.