Study Results
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View full resultsBasic Information
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COMPLETED
NA
1186 participants
INTERVENTIONAL
2016-09-01
2020-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Standard Care
Observations in clinical encounter via video, audio or observational notes.
No interventions assigned to this group
Standard Care + Decision Aid
Observation of clinical encounter using the decision aid via video, audio, or observational notes.
Decision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Interventions
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Decision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Other Intervention Names
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Eligibility Criteria
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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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Park Nicollet Clinic
OTHER
Hennepin County Medical Center, Minneapolis
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Peter A. Noseworthy, M.D.
M.D.
Principal Investigators
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Peter A Noseworthy
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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University of Alabama
Birmingham, Alabama, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Park Nicollet Health Partners
Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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References
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Sivly A, Gorr HS, Gravholt D, Branda ME, Linzer M, Noseworthy P, Hargraves I, Kunneman M, Doubeni CA, Suzuki T, Brito JP, Jackson EA, Burnett B, Wambua M, Montori VM; Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial. BMC Health Serv Res. 2022 Aug 12;22(1):1032. doi: 10.1186/s12913-022-08399-z.
Noseworthy PA, Branda ME, Kunneman M, Hargraves IG, Sivly AL, Brito JP, Burnett B, Zeballos-Palacios C, Linzer M, Suzuki T, Lee AT, Gorr H, Jackson EA, Hess E, Brand-McCarthy SR, Shah ND, Montori VM; SDM4AFib (Shared Decision-Making for Atrial Fibrillation) Trial Investigators *. Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial. J Am Heart Assoc. 2022 Jan 18;11(2):e023048. doi: 10.1161/JAHA.121.023048. Epub 2022 Jan 13.
Kamath CC, Giblon R, Kunneman M, Lee AI, Branda ME, Hargraves IG, Sivly AL, Bellolio F, Jackson EA, Burnett B, Gorr H, Torres Roldan VD, Spencer-Bonilla G, Shah ND, Noseworthy PA, Montori VM, Brito JP; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Cost Conversations About Anticoagulation Between Patients With Atrial Fibrillation and Their Clinicians: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116009. doi: 10.1001/jamanetworkopen.2021.16009.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-005409
Identifier Type: -
Identifier Source: org_study_id
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