SDM for Stroke Prevention in Atrial Fibrillation (SDM4Afib)

• ClinicalTrials.gov Identifier: NCT02905032
• Recruitment Status: Enrolling by invitation
• First Posted: September 19, 2016
• Last Update Posted: August 6, 2020
• Sponsor: Mayo Clinic
• 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: September 9, 2016
• First Posted Date: September 19, 2016
• Last Update Posted Date: August 6, 2020
• Actual Study Start Date: September 1, 2016
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SDM for Stroke Prevention in Atrial Fibrillation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Atrial Fibrillation

Intervention

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

• 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 *

• Kunneman M, Branda ME, Hargraves IG, Sivly AL, Lee AT, Gorr H, Burnett B, Suzuki T, Jackson EA, Hess E, Linzer M, Brand-McCarthy SR, Brito JP, Noseworthy PA, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jul 20. doi: 10.1001/jamainternmed.2020.2908. [Epub ahead of print]
• Kunneman M, Branda ME, Hargraves IG, Sivly AL, Lee AT, Gorr H, Burnett B, Suzuki T, Jackson EA, Hess E, Linzer M, Brand-McCarthy SR, Brito JP, Noseworthy PA, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Sep 1;180(9):1215-1224. doi: 10.1001/jamainternmed.2020.2908.
• Spencer-Bonilla G, Thota A, Organick P, Ponce OJ, Kunneman M, Giblon R, Branda ME, Sivly AL, Behnken E, May CR, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study. Trials. 2020 May 12;21(1):395. doi: 10.1186/s13063-020-04305-2.
• Kunneman M, Branda ME, Noseworthy PA, Linzer M, Burnett B, Dick S, Spencer-Bonilla G, Fernandez CA, Gorr H, Wambua M, Keune S, Zeballos-Palacios C, Hargraves I, Shah ND, Montori VM. Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial. Trials. 2017 Sep 29;18(1):443. doi: 10.1186/s13063-017-2178-y.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: November 2, 2017): 2700
• Original Estimated Enrollment (submitted: September 13, 2016): 900
• Estimated Study Completion Date: September 2021
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02905032
• Other Study ID Numbers: 16-005409; 1R01HL131535 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Peter A. Noseworthy, M.D., Mayo Clinic
• Study Sponsor: Mayo Clinic

Collaborators

• Park Nicollet Clinic
• Hennepin County Medical Center, Minneapolis
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Peter A Noseworthy; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: August 2020