Abstract P268: The Impact Of Covid-19 On A Large Pragmatic Clinical Trial Embedded In Primary Care

Abstract

Introduction: The COVID-19 pandemic has had a significant impact on traditional clinical trial operations, but it is unclear whether the impact persists in pragmatic trials with a centralized study design. The Diuretic Comparison Project (DCP) is a Point-of Care pragmatic trial that operates through a usual care system to compare chlorthalidone and hydrochlorothiazide at preventing major cardiovascular (CV) events and non-cancer death. We assessed the impact of the COVID-19 pandemic on the centralized recruitment, patient follow-up, data collection, and outcome ascertainment performed in the DCP. Methods: We assessed operations in two 8-month periods: Pre-COVID-19 (Jul 2019 - Feb 2020) and Mid-COVID-19 (Jul 2020 - Feb 2021). Enrollment, study medication adherence, blood pressure (BP) and electrolyte follow-up rates, VA records of CV events, all-cause hospitalization, and death rates were compared. Results: Providers agreed to participate at a lower rate, but more patients were contacted and randomized during mid-COVID-19. While BP evaluations decreased, the rates of electrolyte, major CV, and medication prescription records were comparable to the pre-COVID-19 period ( Table 1 ). Conclusions: The DCP was able to recruit and maintain critical data collection at the pre-COVID-19 levels. There were some decreases in BP evaluations, likely due to fewer in-person visits. All-cause VA hospitalizations also decreased, despite rises in COVID-related hospitalizations and death. While the impact on outcome and safety rates awaits complete data from Medicare, the DCP has demonstrated a promising centralized design that can support pragmatic trial operations during a pandemic.