Marleen Kunneman1,2, Megan E Branda1,3,4, Ian G Hargraves1, Angela L Sivly1, Alexander T Lee4, Haeshik Gorr5, Bruce Burnett6, Takeki Suzuki7, Elizabeth A Jackson8, Erik Hess9, Mark Linzer5, Sarah R Brand-McCarthy1,10, Juan P Brito1, Peter A Noseworthy1,11,12, Victor M Montori1. 1. Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota. 2. Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands. 3. Department of Biostatistics and Informatics, Colorado School of Public Health, Anschutz Medical Campus, University of Colorado Denver, Aurora. 4. Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. 5. Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota. 6. Thrombosis Clinic and Anticoagulation Services, Park Nicollet Health Services, St Louis Park, Minnesota. 7. Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson. 8. Department of Internal Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham. 9. Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham. 10. Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota. 11. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota. 12. Heart Rhythm Services, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
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.
RCT Entities:
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.
Authors: Claudia L Zeballos-Palacios; Ian G Hargraves; Peter A Noseworthy; Megan E Branda; Marleen Kunneman; Bruce Burnett; Michael R Gionfriddo; Christopher J McLeod; Haeshik Gorr; Juan Pablo Brito; Victor M Montori Journal: Mayo Clin Proc Date: 2019-01-11 Impact factor: 7.616
Authors: Mark H Eckman; Alexandru Costea; Mehran Attari; Jitender Munjal; Ruth E Wise; Carol Knochelmann; Matthew L Flaherty; Pete Baker; Robert Ireton; Brett M Harnett; Anthony C Leonard; Dylan Steen; Adam Rose; John Kues Journal: Am Heart J Date: 2018-01-12 Impact factor: 4.749
Authors: Marleen Kunneman; Michael R Gionfriddo; Freddy J K Toloza; Fania R Gärtner; Gabriela Spencer-Bonilla; Ian G Hargraves; Patricia J Erwin; Victor M Montori Journal: Patient Educ Couns Date: 2018-11-12
Authors: Angela Fagerlin; Brian J Zikmund-Fisher; Peter A Ubel; Aleksandra Jankovic; Holly A Derry; Dylan M Smith Journal: Med Decis Making Date: 2007-07-19 Impact factor: 2.583
Authors: Xiaoxi Yao; Neena S Abraham; G Caleb Alexander; William Crown; Victor M Montori; Lindsey R Sangaralingham; Bernard J Gersh; Nilay D Shah; Peter A Noseworthy Journal: J Am Heart Assoc Date: 2016-02-23 Impact factor: 5.501