Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Mayo Clinic
- Enrollment
- 1186
- Locations
- 5
- Primary Endpoint
- Number of Clinician Recommendation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
Detailed Description
The goal of this study is to determine the extent to which the Anticoagulation Choice tool promotes shared decision making and its impact on anticoagulation use and adherence versus standard care in patients with nonvalvular atrial fibrillation.
Investigators
Peter A. Noseworthy, M.D.
M.D.
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •All clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion
- •Patient Inclusion Criteria:
- •≥ 18 years of age
- •Chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (CHA2D2-VASc Score ≥ 1, or 2 in women)
- •Able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent
Exclusion Criteria
- •Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication
Outcomes
Primary Outcomes
Number of Clinician Recommendation
Time Frame: 1 month
The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.
Number of Clinician Satisfied Encounters
Time Frame: 1 month
The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.
Secondary Outcomes
- Number of Participants With Anticoagulant Medication Use(12 months)
- Patient Involvement(1 month)
- Encounter Duration(1 month)