June 18, 2021: The MITIGATE Study: Insights from a Decentralized, Virtual, Electronic Health Record-Based Pragmatic Clinical Trial (Andrew Ambrosy, MD; Alan Go, MD)

Posted on by Gina Uhlenbrauck

Speakers

Andrew P. Ambrosy, MD
Research Scientist
Cardiovascular and Metabolic Conditions Research
Solution Through Technology and Advanced Analytic Research (STAR) Group
Kaiser Permanente Northern California Division of Research

Alan S. Go, MD
Regional Medical Director, Clinical Trials Program
Associate Director, Cardiovascular and Metabolic Conditions Research
Director, Solutions Through Technology and Advanced Analytics Research (STAR) Group

Topic

The MITIGATE Study: Insights from a Decentralized, Virtual, Electronic Health Record-Based Pragmatic Clinical Trial

Keywords

MITIGATE; Cardiovascular health; Electronic health records; Upper respiratory illness (URI); Anti-inflammatory effects; Decentralized trial

Key Points

  • The MITIGATE trial is evaluating the real-world clinical effectiveness of pretreatment with an omega-3 fatty acid (icosapent ethyl) to prevent or reduce viral upper respiratory illness–related morbidity and mortality in patients with established atherosclerotic cardiovascular disease.
  • The study is an EHR-based, open-label, randomized pragmatic clinical trial conducted within the Kaiser Permanente Northern California integrated healthcare system.
  • To date, MITIGATE has shown the feasibility of rapid, efficient decentralized recruitment of a diverse, real-world population for a protocol testing an intervention without the need for a complicated pre-existing or new clinical trial infrastructure.

Discussion Themes

Did the study rely solely on routinely collected data in the EHR or did you need to collect supplemental data?

How did you manage the volume of patient outreach—through software tools or manually?

While the study has no face-to-face clinical encounters, patients receive monthly contact, and medication refills are centrally managed.

Findings are not necessarily generalizable to prevention in other at-risk groups nor the use of icosapent ethyl as an active treatment for symptomatic COVID-19.

Read more about MITIGATE at ClinicalTrials.gov and American Heart Journal.

Tags

#pctGR, @Collaboratory1