SDM for Stroke Prevention in Atrial Fibrillation

Study Overview
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Brief Summary
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The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

Detailed Description
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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.

Official Title
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Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Decision Aid


Participation Criteria
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Eligibility Criteria
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Clinician 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 Patient Exclusion Criteria: • Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Observations in clinical encounter via video, audio or observational notes. | |
| Active Comparator: Standard Care + Decision Aid<br>Observation of clinical encounter using the decision aid via video, audio, or observational notes. | Behavioral: Decision Aid<br>* Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.<br>* Other names: DA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Clinician Satisfied Encounters | 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. | 1 month | 
| Number of Clinician Recommendation | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Anticoagulant Medication Use | The number of subjects who chose to start or continue receive an anticoagulant medication. | 12 months | 
| Patient Involvement | Patient involvement in decision-making as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale. The 12 items measure observed patient involvement. Each of the 12 items have possible scores that range from 0 (the behavior is not observed) to 4 (the behavior is exhibited to a very high standard). To calculate the total score for each patient, the 12 items are summed, divided by 48 (the maximum possible score), and multiplied by 100. Total score minimum is 0, maximum is 100. The higher the total score the higher the patient involvement. | 1 month | 
| Encounter Duration | The length of time for the subjects visit with the clinician, as measured in minutes. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Afib, Atrial fib, Shared, Decision, Making, Aid, AF