Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter

• Registration Number: NCT02524977
• Lead Sponsor: University of Cincinnati

Brief Summary

Study objective was to improve decision-making and thromboprophylaxis for patients with Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool for individual patient-level decision-making about oral anticoagulant therapy. To accomplish these goals, the investigators studied the incremental impact of adding a quality-improvement (QI) intervention to an educational package (for practice staff and clinicians) using a computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST) for individual patient-level decision-making about oral anticoagulant therapy in patients with non-valvular AF. The decision support tool incorporates individual patients' risk factor profiles for ischemic stroke and bleeding and provides a recommendation for treatment based upon the projected quality-adjusted life expectancy gained or lost with the addition of either oral anticoagulant therapy or aspirin compared with no thromboprophylaxis.

Detailed Description

Setting - Cluster randomized trial. Setting - Primary care practices of an integrated healthcare system. Participants - 1,493 adults with non-valvular AF seen between April 2014 and March 2015.

Intervention - Treatment recommendations were made by an Atrial Fibrillation Decision Support Tool (AFDST) based on projections for quality-adjusted life expectancy calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-17
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-11-10
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-27
• Last Update Submitted: 2018-09-27
• Results First Posted: 2018-10-25
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Study subjects were physicians in our primary care network.
• Patients included in the study were identified through our health system's clinical data store with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), diagnosis of atrial fibrillation (427.31) or atrial flutter (427.32)

Exclusion Criteria

Diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2) or heart valve replacement (V42.3).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Discordant Antithrombotic Therapy	One year	Changes in the proportion of patients with current therapy that was discordant from the decision support tool recommendation between the start and finish date of the study (one year period).

Secondary Outcome Measures

Name	Time	Method
Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed	One year	Change in discordance between decision support tool recommendation and actual treatment among patients whose physicians reviewed the decision support tool report.

Trial Locations

Locations (1)

Primary Care Practices of UC Health; 🇺🇸 Cincinnati, Ohio, United States