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

Summary

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.

Conditions

• Atrial Fibrillation
• Stroke

Interventions

BEHAVIORAL

Early Patient-Level and Provider-Level Educational Intervention

Letters to patients that (1) explain to the patient that he or she appears to have AF, characterize the risk of stroke, and emphasize that although there may be a medical reason, the patient does not seem to be on an anticoagulant and (2) encourage the patient to discuss this with his or her provider to ask if he or she might benefit from OAC therapy to prevent stroke. Early intervention letters to providers explain this project, the nature of the problem, and identify a list of the provider's patients who have been contacted, as the provider and patient letters will be sent at approximately the same time; describe evidence and guidelines regarding oral anticoagulation.

BEHAVIORAL

Delayed Provider-Level Educational Intervention

Delayed intervention letters to patients' providers, where they may be identified, that explain this project, the nature of the problem, and identify a list of their patients who are flagged as at risk for stroke and have not been treated with an oral anticoagulant; describe evidence and guidelines regarding oral anticoagulation.

Sponsors & Collaborators

• Duke Clinical Research Institute

  collaborator OTHER

• Clinical Trials Transformation Initiative

  collaborator OTHER

• Humana Inc.

  collaborator INDUSTRY

• Aetna, Inc.

  collaborator INDUSTRY

• OptumInsight Life Sciences, Inc.

  collaborator UNKNOWN

• Food and Drug Administration (FDA)

  collaborator FED

• Harvard Pilgrim Health Care

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-25

Primary Completion

2020-09-30

Completion

2021-12-31

Countries

• United States

Study Locations