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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 : Completed
First Posted : September 19, 2016
Results First Posted : January 25, 2022
Last Update Posted : January 25, 2022
Sponsor:
Collaborators:
Park Nicollet Clinic
Hennepin County Medical Center, Minneapolis
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Peter A. Noseworthy, M.D., Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: Decision Aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : June 27, 2019
Actual Study Completion Date : June 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Number of Participants With Anticoagulant Medication Use [ Time Frame: 12 months ]
    The number of subjects who chose to start or continue receive an anticoagulant medication.

  2. Patient Involvement [ Time Frame: 1 month ]
    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.

  3. Encounter Duration [ Time Frame: 1 month ]
    The length of time for the subjects visit with the clinician, as measured in minutes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Mayo Clinic
Park Nicollet Clinic
Hennepin County Medical Center, Minneapolis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Peter A Noseworthy Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Peter A. Noseworthy, M.D., Mayo Clinic:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peter A. Noseworthy, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02905032    
Other Study ID Numbers: 16-005409
1R01HL131535 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2016    Key Record Dates
Results First Posted: January 25, 2022
Last Update Posted: January 25, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter A. Noseworthy, M.D., Mayo Clinic:
Afib
Atrial fib
Shared
Decision
Making
Aid
AF
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes