IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Stroke

In brief

The purpose of this study is to use a decentralized claims database to determine whether education on stroke prevention in atrial fibrillation (AF) among AF patients and their providers can result in increased use of oral anticoagulants (OAC) for stroke prevention among those AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a prospective, randomized, open-label education intervention trial to evaluate the effect of the early patient and provider education interventions on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 international normalized ratio \[INR tests\] over the course of the follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time). A total of approximately 80,000 patients will be enrolled within multiple major health plans across the United States. The randomization will be performed by the central coordinating center, and the health plans will mail the educational intervention materials to their members and providers.

Key facts

Study ID

NCT03259373

Run by

Harvard Pilgrim Health Care

People needed

64666

Starts

2017-09-25

Expected to finish

2021-12-31

Last updated by the study team

2025-04-09

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Two or more diagnoses of AF (ICD-9 and/or 10 codes) at least one day apart and with at least one diagnosis within the last 12 months prior to the last date in the current approved data used for cohort identification
• CHA₂DS₂-VASc score of 2 or greater
• Medical and pharmacy insurance coverage of at least the prior year as identified via administrative claims databases of one of the participating data partners as of the date of randomization
• Age 30 years or greater as of the last date in the current approved data used for cohort identification

You may not qualify if…

• Evidence of OAC medication fill during the 12 months prior to randomization (determined at randomization for the early intervention cohort and 12 months post-randomization for the delayed intervention cohort)
• Conditions other than AF that require anticoagulation, including treatment of deep venous thrombosis, pulmonary embolism, or ever having had a mechanical prosthetic heart valve prior to the last date in the current approved data used for cohort identification
• Pregnancy within 6 months of the last date in the current approved data used for cohort identification
• Any known history of intracranial hemorrhage prior to the last date in the current approved data used for cohort identification
• Hospitalization for bleeding within the last 6 months of the last date in the current approved data used for cohort identification
• Patients with recent P2Y12 antagonist use (i.e. clopidogrel, prasugrel, ticlopidine, or ticagrelor within 90 days of the last date in the current approved data used for cohort identification

Where it is running

• Humana Healthcare Research, Inc. — Louisville, Kentucky, United States
• Harvard Pilgrim Health Care — Quincy, Massachusetts, United States
• OptumInsight, Inc — Waltham, Massachusetts, United States
• Aetna, Inc. — Blue Bell, Pennsylvania, United States

Full record on ClinicalTrials.gov

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