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

Atrial Fibrillation Clinical Trial

Official title:

Impact of a Quality Improvement And Education Initiative on 'Appropriate' Use of Anticoagulant Therapy in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524977
• Other study ID #: 2013-0017
• Secondary ID: 1UL1TR001425-01
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: September 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Behavioral:
• Decision Support
Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk
• Educational Intervention Only
Educational conference series

Locations

Country	Name	City	State
United States	Primary Care Practices of UC Health	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
University of Cincinnati	Bristol-Myers Squibb, National Center for Advancing Translational Science (NCATS), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Eckman MH, Lip GY, Wise RE, Speer B, Sullivan M, Walker N, Kissela B, Flaherty ML, Kleindorfer D, Baker P, Ireton R, Hoskins D, Harnett BM, Aguilar C, Leonard AC, Arduser L, Steen D, Costea A, Kues J. Impact of an Atrial Fibrillation Decision Support Tool — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Discordant Antithrombotic Therapy	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).	One year
Secondary	Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed	Change in discordance between decision support tool recommendation and actual treatment among patients whose physicians reviewed the decision support tool report.	One year