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

Basic Details
Date Posted
Tuesday, May 7, 2019
Status
Complete
Medical Product
anticoagulant
Health Outcome(s)
atrial fibrillation
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 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.

Deliverable(s) (3)
IMPACT-AFib Protocol IMPACT-AFib Inclusion and Exclusion Code List IMPACT-AFib Statistical Analysis Plan
Information
Time Period
May 2017 – December 2021
Population / Cohort
Patients with atrial fibrillation
Related Link(s)
FDA-Catalyst - Using FDA's Sentinel Initiative for Large-Scale Pragmatic Randomized Trials: Approach and Lessons Learned During the Planning Phase of the First Trial
Underuse of Oral anticoagulants in privately insured patients with atrial fibrillation: A population targeted by IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in atrial fibrillation patients (IMPACT-AFib)
Practical Challenges in the Conduct of Pragmatic Trials Embedded in Health Plans: Lessons of IMPACT-AFib, an FDA-Catalyst Trial
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 Member(s)

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

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

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

Sara Calvert, PharmD; Duke Clinical Research Institute and Clinical Trials Transformation Initiative, Duke University Medical Center, Durham, NC

Noelle Cocoros, DSc, MPH; Meighan Rogers Driscoll, MPH; Robert Jin, MS; Andrew Petrone, MPH; Jennifer Noble; 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, a CVS Health company, Blue Bell, PA

Vinit Nair, BPharm, MS, RPh; Thomas Harkins, MPH, MA; Yunping Zhou, MS; Humana Healthcare Research Inc., Louisville, KY

Nancy Lin, ScD; OptumInsight Life Sciences Inc., Boston, MA

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

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