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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 : 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

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE September 1, 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SDM for Stroke Prevention in Atrial Fibrillation
Official Title  ICMJE Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial
Brief Summary The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Behavioral: Decision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Other Name: DA
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Decision Aid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 2, 2017)
2700
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2016)
900
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905032
Other Study ID Numbers  ICMJE 16-005409
1R01HL131535 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peter A. Noseworthy, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • Park Nicollet Clinic
  • Hennepin County Medical Center, Minneapolis
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Peter A Noseworthy Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP