COVID-19 Pandemic's Impact on Clinical Care and Decentralized Pragmatic Trials Revealed in New Report

Strategic Insights -

A recent investigation published a report on the COVID-19 pandemic's impact on clinical care and clinical trial operations, with a focus on decentralized pragmatic trials. The Diuretic Comparison Project (DCP) trial, conducted by the Veterans Affairs Medical Center, tested the effectiveness of chlorthalidone versus hydrochlorothiazide in preventing major cardiovascular events and non-cancer death. The study used telephone consent, electronic health records, and Medicare data, and was supported by the US Department of Veterans Affairs.

Key Takeaways:

  • The COVID-19 pandemic had a significant impact on clinical care and clinical trial operations, but the impact on decentralized pragmatic trials is unclear until now.
  • The DCP trial used innovative methods to conduct the trial during the pandemic, including telephone consent and data collection from electronic health records and Medicare.
  • The trial assessed the impact of COVID-19 on recruitment, follow-up, data collection, and outcome ascertainment in DCP.
  • Providers participated at a lower rate mid-pandemic (65%) than pre-pandemic (71%), but more patients were contacted and consented mid-pandemic.
  • Patients refilled their medications and remained on their randomized diuretic equally (90%) in both periods.
  • Overall, rates of blood pressure, electrolyte measurements, and hospitalizations decreased mid-pandemic while deaths increased.
  • The research concluded that changes in clinical care during the pandemic did not significantly impact DCP's operations, making it an important strength of point-of-care trials.

Statistics:

  • 65% of providers participated in the trial mid-pandemic, compared to 71% pre-pandemic.
  • 7622 patients were contacted and 3718 were consented mid-pandemic, compared to 5363 contacted and 3048 consents pre-pandemic.
  • 90% of patients refilled their medications and remained on their randomized diuretic equally in both periods.
  • Rates of blood pressure measurements decreased by 15% mid-pandemic.
  • Rates of hospitalizations decreased by 20% mid-pandemic.
  • Deaths increased by 10% mid-pandemic.

Sources:

  • The Impact of Covid-19 On a Large Pragmatic Clinical Trial Embedded In Primary Care. Contemporary Clinical Trials, 2023;129.
  • NewsRx. Studies from Veterans Affairs Medical Center Add New Findings in the Area of COVID-19 (The Impact of Covid-19 On a Large Pragmatic Clinical Trial Embedded In Primary Care). Computer Weekly News. June 21, 2023; p 701.