SDM for Stroke Prevention in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SDM4Afib  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905032
• Other study ID #: 16-005409
• Secondary ID: 1R01HL131535
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: June 27, 2020

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1186
• Est. completion date: June 27, 2020
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Decision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Park Nicollet Health Partners	Saint Louis Park	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Hennepin County Medical Center, Minneapolis, National Heart, Lung, and Blood Institute (NHLBI), Park Nicollet Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Anticoagulant Medication Use	The number of subjects who chose to start or continue receive an anticoagulant medication.	12 months
Secondary	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
Secondary	Encounter Duration	The length of time for the subjects visit with the clinician, as measured in minutes.	1 month

External Links

•   Mayo Clinic Clinical Trials