|Project Title||Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib)|
Tuesday, May 7, 2019
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 protocol for public comment on March 1, 2017 through March 15, 2017. Revised versions were approved by FDA on October 2, 2017, November 24, 2017, April 19, 2018, February 27, 2019. The latter was approved for implementation by BRANY IRB on March 19, 2019. A log of changes is included in the revised protocol (v5.0).
The statistical analysis plan was approved by both entities in February 2019.
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
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
|Population / Cohort||
Patients with atrial fibrillation
May 2017 – December 2021
- Vaccines, Blood & Biologics
- Devices and Radiologic Health