Status:
COMPLETED
Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
Lead Sponsor:
University of Utah
Collaborating Sponsors:
American Heart Association
Patient-Centered Outcomes Research Institute
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and health outcomes for at-risk participants wi...
Detailed Description
Background Information: Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and it continues to grow in prevalence, afflicting an estimated 3 million Americans. While treatment ...
Eligibility Criteria
Inclusion
- Patient Participants -
- Adults (18 and older)
- Are diagnosed with Atrial Fibrillation
- Are aware they have been diagnosed with Atrial Fibrillation
- Participants with additional risk of thromboembolic events (CHA2DS2-VASc scores ≥ 1 in men and ≥ 2 in women)
Exclusion
- Participants deemed by their clinician or research personnel to be ineligible for consideration of taking or of foregoing anticoagulation
- Have deficits in cognitive abilities or sensory input
- Have a language barrier significant enough to impede shared decision making and/or the provision of written informed consent.
- Clinician Participants -
- Inclusion Criteria:
- 1\. All clinicians (MDs, NP/PAs, PharmDs, APPs, etc.) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion.
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
1117 Patients enrolled
Trial Details
Trial ID
NCT04357288
Start Date
December 16 2020
End Date
September 20 2024
Last Update
January 8 2025
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Northwestern University
Chicago, Illinois, United States, 60611
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
The Mayo Clinic
Rochester, Minnesota, United States, 55905