SDM for Stroke Prevention in Atrial Fibrillation (SDM4Afib)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02905032|
Recruitment Status : Enrolling by invitation
First Posted : September 19, 2016
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Behavioral: Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
No Intervention: Standard Care
Observations in clinical encounter via video, audio or observational notes.
Active Comparator: Standard Care + Decision Aid
Observation of clinical encounter using the decision aid via video, audio, or observational notes.
Behavioral: Decision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Other Name: DA
- SDM Quality - Knowledge Transfer, Knowledge of Risk, Collaborative Agreement, Patient decision satisfaction, Quality of communication, Patient satisfaction with encounter, Clinician satisfaction. [ Time Frame: After end of enrollment (1 month) ]SDM quality will measure (a) knowledge transfer; (b) concordance; (c) quality of communication and satisfaction with shared decision making; and (d) satisfaction with the decision-making process. Knowledge Transfer-6 questions about afib and anticoagulation. Knowledge of Risk-1 question about risk of stroke. Collaborative Agreement-will assess decision concordance between patient and clinician. Patient decision satisfaction-16 items of Decisional Conflict Scale. Quality of communication- modified questions from the CAHPS Clinician and Group survey. Patient satisfaction with encounter- asking patients whether they would recommend the approach used to others for other discussions. Clinician satisfaction- questioning satisfaction with discussion about anticoagulation medication choice and whether they would recommend the approach used to other clinicians for other discussions.
- SDM Processes [ Time Frame: After end of enrollment (1 month) ]SDM processes will be assessed based on the review of video/audio or audio only recordings of the clinical encounter.
- Anticoagulation Use [ Time Frame: 12 months post enrollment completion ]Anticoagulation start and continuation rates will be calculated along with percent of days covered based off pharmacist reporting patient fill rates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905032
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Park Nicollet Health Partners|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Peter A Noseworthy||Mayo Clinic|