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    Original Investigation
    July 20, 2020

    Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial

    Author Affiliations
    • 1Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota
    • 2Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands
    • 3Department of Biostatistics and Informatics, Colorado School of Public Health, Anschutz Medical Campus, University of Colorado Denver, Aurora
    • 4Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
    • 5Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota
    • 6Thrombosis Clinic and Anticoagulation Services, Park Nicollet Health Services, St Louis Park, Minnesota
    • 7Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson
    • 8Department of Internal Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham
    • 9Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham
    • 10Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota
    • 11Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
    • 12Heart Rhythm Services, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
    JAMA Intern Med. 2020;180(9):1215-1224. doi:10.1001/jamainternmed.2020.2908
    Key Points

    Question  Does use of the Anticoagulation Choice Shared Decision Making encounter tool affect the quality of shared decision-making and anticoagulant treatment selection in patients with atrial fibrillation who are at risk of experiencing stroke?

    Findings  In this randomized clinical trial of 922 patients with atrial fibrillation and 151 clinicians, use of the Anticoagulation Choice Shared Decision Making encounter tool resulted in several improvements in markers of shared decision-making quality and clinician satisfaction without changing anticoagulant treatment rates or encounter length.

    Meaning  The results indicate that use of a tool for shared decision-making in the clinical encounter contributes to the care of patients with atrial fibrillation who are considering anticoagulant treatment.

    Abstract

    Importance  Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear.

    Objective  To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF.

    Design, Setting, and Participants  This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019.

    Interventions  Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter.

    Main Outcomes and Measures  Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process.

    Results  The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, −0.3 to 2.5 minutes).

    Conclusion and Relevance  The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF.

    Trial Registration  ClinicalTrials.gov Identifier: NCT02905032

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