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NCT03259373 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Harvard Pilgrim Health Care.

Completed
Registry status
NA
Development phase
64,666
Enrollment target

NCT03259373: Completed NA study, sponsored by Harvard Pilgrim Health Care.

NCT03259373 is a NA study that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 64,666 participants, above the 1,402-participant average among 58,714 other NA trials with a reported enrollment target (4512% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03259373, a NA study, has completed, sponsored by Harvard Pilgrim Health Care.

COMPLETED
Registry status
NA
Development phase
64,666 participants
Enrollment target

Study 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.

Primary Outcome

Evaluate the effect of the patient and provider education interventions (versus usual care with delayed provider education intervention) on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) over the course of the 12 months of follow-up.

Interventions

  • BEHAVIORAL Early Patient-Level and Provider-Level Educational Intervention
  • BEHAVIORAL Delayed Provider-Level Educational Intervention

Trial Details

FieldValue
Enrollment Target 64,666 participants
Start Date 2017-09-25
Est. Completion 2021-12-31
Phase NA
Harvard Pilgrim Health Care

28 total trials

What the finished NCT03259373 record still lists

NCT03259373 is an interventional study that assigns participants to a tested intervention. Its 64,666 participants enrollment target places it among the larger protocols in the corpus, above the 1,402-participant average among 58,714 other NA trials with a reported enrollment target (4512% higher).

The record links to 0 conditions, and to 2 interventions - of which Early Patient-Level and Provider-Level Educational Intervention is the first listed.

NCT03259373 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03259373 about?

NCT03259373 is a clinical study titled "IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation". 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 guidel...

What is the current status of trial NCT03259373?

This trial is currently completed. It is a NA study. The enrollment target is 64,666 participants. The study started on 2017-09-25. Estimated completion is 2021-12-31.

What interventions are being tested in trial NCT03259373?

The interventions under investigation include: Early Patient-Level and Provider-Level Educational Intervention (BEHAVIORAL), Delayed Provider-Level Educational Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03259373?

This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03259373's enrollment target sits among peer trials

64,666 4th of 2000 higher than 1,997 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03259373, the US trial registry maintained by the National Library of Medicine. NCT03259373 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.