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.
ABSTRACT
INTRODUCTION AND OBJECTIVE: Spina Bifida (SB) is a congenital spinal defect with multiple urologic manifestations requiring life-long urologic care. Transition to adult health care can be particularly difficult for patients with complex medical issues, especially during COVID-19. Our team created an online educational series for patients with SB to help provide education and community building. Herein, we describe our experience with a virtual SB Education Series and the results of survey-based patient experience through a virtual platform. METHODS: Patients with SB ages 16-24 and their caregivers were identified at a single tertiary academic medical center and were invited to the zoom education day series. Pre and post session surveys were collected, and data analyzed. RESULTS: There were a total of 68 registrations for 4 conferences held between 5/3/20-12/9/20. 24, 24, 21, 36 invitations were sent out before each session and 18,18, 11, 21 patients attended each education session, respectively. A total of 46% (31/68) participants completed the pre-survey and 19% (13/68) completed the post-survey. The survey results can be found in Table 1. Participants were comfortable using telehealth for medical visits (4.87), found them easy (4.69) and would use telehealth for future appointments (4.7). This did not increase significantly after the educational sessions. However, there was a significant increase in patients' comfort of navigating non-emergent medical problems during the COVID-19 pandemic between pre and post-survey results (4.07 vs 5.17, p <0.01). Importantly, participants did not feel that they lost the ability to connect with other individuals during the pandemic (4.45) and were strongly in favor of attending future conferences. CONCLUSIONS: This program aimed to reach patients with SB who were transitioning from pediatric to adult urology. Attendance increased with higher volume of direct outreach of patients in the adult and pediatric SB clinics. Importantly, by engaging in online educational series, participants became more comfortable managing non-emergent urologic issues. Transitional urology patients with SB can benefit from online educational sessions and this platform was well received. Future directions will be to increase participants and determine the effectiveness of video educational session on participants' access to care.