January 5, 2018: IMPACT-AFib: An 80,000 Person Randomized Trial Using the Sentinel Initiative Platform

Speakers

Noelle M. Cocoros, DSc, MPH
Epidemiologist, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute

Christopher B. Granger, MD, FACC, FAHA
Professor of Medicine, Duke University
Director, Cardiac Care Unit
Duke University Medical Center

Richard Platt, MD, MS
Professor and Chair, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute

Sean Pokorney, MD
Assistant Professor of Medicine, Duke University

Topic

IMPACT-AFib: An 80,000 Person Randomized Trial Using the Sentinel Initiative Platform

Keywords

Pragmatic clinical trial; Sentinel Initiative; IMPACT-AFib; Atrial fibrillation; Data sharing

Key Points

  • The Sentinel Initiative uses the Common Data Model to curate and distribute large amounts of electronic health record (EHR) data from a diverse group of data partners.
  • IMPACT-AFib (an atrial fibrillation trial) used Sentinel registry data to find eligible patients with at least one oral anticoagulation prescription fill.
  • The trial looked at usual care with delayed provider anticoagulation intervention versus early patient and provider anticoagulation intervention, using access to pharmacy records.
  • Is there an ethical question raised by delaying intervention in the usual care group?

Discussion Themes

Oral anticoagulant (OAC) underuse is a public health priority and also a priority of health plans, which made health plan stakeholders very engaged in the IMPACT A-Fib trial.

IMPACT-AFib found efficiencies with a single IRB that facilitated streamlined processes across multiple institutions.

Research weighed practical considerations against ethical concerns, in that by consenting individuals for the trial, researchers would be performing a type of intervention and thereby negating the comparison between true control and intervention groups.

FDA sponsored the IMPACT-AFib trial to demonstrate feasibility but researchers hope that other sponsors will be open to trials leveraging Sentinel in the next year or so.

For More Information

For information on data sharing solutions, visit the Living Textbook http://bit.ly/2m24zMc
Tags

@PCTGrandRounds, @Collaboratory1, #SentinelInitiative, #EHR, #PatientBrochure, #PatientBrochure, #pctGR