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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Kunneman reported receiving grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Ms Branda reported receiving grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Hargraves reported receiving grants from the National Institutes of Health during the conduct of the study. Ms Sivly reported receiving grants from Mayo Clinic during the conduct of the study and outside the submitted work. Dr Gorr reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Burnett reported receiving grants and personal fees from the Mayo Clinic and the National Institutes of Health during the conduct of the study and personal fees from the Mayo Clinic outside the submitted work. Dr Jackson reported receiving grants from the Mayo Clinic during the conduct of the study and research funding from Amgen and the National Institutes of Health outside the submitted work. Dr Hess reported receiving grants from the Patient-Centered Outcomes Research Institute outside the submitted work. Dr Linzer reported receiving grants from the National Institutes of Health during the conduct of the study and grants from the American College of Physicians, the American Medical Association, and the Institute for Healthcare Improvement outside the submitted work. Dr Brito reported being the medical director of the Shared Decision Making National Resource Center at the Mayo Clinic. Dr Montori reported receiving grants from the National Heart, Lung, and Blood Institute during the conduct of the study and serving as board chair of The Patient Revolution outside the submitted work. No other disclosures were reported.

Figures

Figure.. CONSORT Diagram

SDM indicates shared decision-making.