Grand Rounds August 26, 2022: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial (Areef Ishani, MD, MS)

Posted on by terren.green@duke.edu

Speaker

Areef Ishani, MD MS
Director, Primary Care and Specialty Medicine Service Line
Minneapolis VA Health Care System
Professor of Medicine
University of Minnesota

 

 

Keywords

VA Point of Care Program; Diuretic Comparison Project (DCP); major adverse cardiovascular events (MACE); chlorthalidone (CTD); hydrochlorothiazide (HCTZ); Pragmatic Clinical Trial; electronic consent; comparative effectiveness studies

 

Key Points

  • The VA Point of Care Program preforms large inexpensive randomized controlled trials that are pragmatic and leverage the electronic medical record.
  • The Diuretic Comparison Project (DCP), one of the first full scale RCTs in the VA Point of Care Program, investigates if treatment with chlorthalidone (CTD) reduces major adverse cardiovascular events (MACE) compared with hydrochlorothiazide (HCTZ) in older veterans with hypertension.
  • The DCP was a multi-site pragmatic clinical trial where recruitment, consent, randomization, filling out drug orders, and assessing outcomes was done centrally by study staff, while usual care was left to the de-centralized sites without study staff present.
  • One of the biggest obstacles was a lack of a local study site investigator which made site recruitment difficult. Sites were worried about additional burden to staff. The study handled this concern by embedding the study procedures within usual care practices and streamlining workflow to keep it low intensity for the primary care provider.
  • Keys to the successful recruitment for the DCP were consent embedded in the electronic medical record, a dedicated recruitment call center outside the study team.
  • Outcomes from the DCP are being collected through a combination of manual adjudication, algorithms for primary outcome events from the Corporate data warehouse (EHR), Medicare reports, and the National Death Index.

Learn more

about the DCP study and the VA Point of Care Program.

Discussion Themes

– The DCP study will be used as a model for future comparative effectiveness studies within the VA Point of Care Program.

– The call center used in the DCP was a 5 person dedicated recruitment operation. Centralizing recruitment allows pragmatic trials to be very nimble.

Tags

#pctGR, @Collaboratory1