The impact of COVID-19 on a large pragmatic clinical trial embedded in primary care.

ABSTRACT:

Introduction

The COVID-19 pandemic had significant impact on clinical care and clinical trial operations, but the impact on decentralized pragmatic trials is unclear. The Diuretic Comparison Project (DCP) is a Point-of Care (POC) pragmatic trial testing whether chlorthalidone is superior to hydrochlorothiazide in preventing major cardiovascular (CV) events and non-cancer death. DCP utilized telephone consent, data collection from the electronic health record and Medicare, forwent study visits, and limited provider commitment beyond usual care. We assessed the impact of COVID-19 on recruitment, follow-up, data collection, and outcome ascertainment in DCP.

Methods

We compared data from two 8-month periods: Pre-Pandemic (July 2019-February 2020) and Mid-Pandemic (July 2020-Febr

SUBMITTER: Leatherman SM 

PROVIDER: S-EPMC10080857 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature