Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib)

Project Title Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib)
Date Posted
Friday, May 11, 2018
Status
In progress
Deliverables
Description

An individually randomized trial of a patient and provider level educational intervention to increase anticoagulant use among untreated members with atrial fibrillation and increased risk of stroke (i.e. CHA2DS2-VASc score ≥2). This project is a proof of concept effort, the first trial conducted using Sentinel Infrastructure, and will inform future interventional studies that are designed to utilize existing healthcare data as part of their design.

The Sentinel Operations Center posted a draft surveillance plan for public comment on March 1, 2017 through March 15, 2017. Revised versions were approved by FDA on October 2, 2017, November 24, 2017, and April 19, 2018. The latter was approved for implementation by BRANY IRB on May 2, 2018. A log of changes is included in the revised protocol (v4.0).

Workgroup Leader(s)

Richard Platt MD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Christopher Granger MD; Sean Pokorney MD, MBA; Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, NC

Workgroup Members

Jacqueline Corrigan-Curay MD, JD; David Martin MD, MPH; Dianne Paraoan MPH, BSN; Center for Drug Evaluation and Research, Office of Medical Policy, FDA, Silver Spring, MD

Jennifer Goldsack MChem, MA, MBA, CPHQ; Clinical Trials Transformation Initiative, Durham, NC

Hussein Al-Khalidi PhD; Wensheng He PhD; Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC

Emily O’Brien PhD; Sana Al-Khatib MD, MHS; Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, NC

Noelle Cocoros DSc, MPH; Crystal Garcia MPH; Robert Jin MS; Hana Lipowicz MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Kevin Haynes PharmD, MSCE; Lauren Parlett PhD; HealthCore, Inc., Alexandria, VA

Cheryl Walraven PhD; Annemarie Kline MS, CHES; Daniel Knecht MD, MBA; Aetna: Aetna Informatics, Blue Bell, PA

Vinit Nair BPharm, MS, RPh; Thomas Harkins MPH, MA; Yunping Zhou MS; Comprehensive Health Insights, Humana Inc., Louisville, KY

Nancy Lin ScD; OptumInsight Inc, Waltham, MA

Debbe McCall BS, MBA; Rowan Tree Perspectives Consulting, Murrieta, CA

Medical Product
anticoagulant
Health Outcome
atrial fibrillation
Population / Cohort
Patients with atrial fibrillation
Time Period
May 2017 – Spring 2021
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