Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Peter A Noseworthy Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter A. Noseworthy, M.D., Mayo Clinic:
Afib
Atrial fib
Shared
Decision
 Making
Aid
AF
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes