Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial
Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-01-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.121.023048 |
| _version_ | 1798020143648866304 |
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| author | Peter A. Noseworthy Megan E. Branda Marleen Kunneman Ian G. Hargraves Angela L. Sivly Juan P. Brito Bruce Burnett Claudia Zeballos‐Palacios Mark Linzer Takeki Suzuki Alexander T. Lee Haeshik Gorr Elizabeth A. Jackson Erik Hess Sarah R. Brand‐McCarthy Nilay D. Shah Victor M. Montori |
| author_facet | Peter A. Noseworthy Megan E. Branda Marleen Kunneman Ian G. Hargraves Angela L. Sivly Juan P. Brito Bruce Burnett Claudia Zeballos‐Palacios Mark Linzer Takeki Suzuki Alexander T. Lee Haeshik Gorr Elizabeth A. Jackson Erik Hess Sarah R. Brand‐McCarthy Nilay D. Shah Victor M. Montori |
| author_sort | Peter A. Noseworthy |
| collection | DOAJ |
| description | Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032. |
| first_indexed | 2024-04-11T16:52:52Z |
| format | Article |
| id | doaj.art-13d1cc89a8264ac4a520ff67abf194eb |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-11T16:52:52Z |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-13d1cc89a8264ac4a520ff67abf194eb2022-12-22T04:13:21ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802022-01-0111210.1161/JAHA.121.023048Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical TrialPeter A. Noseworthy0Megan E. Branda1Marleen Kunneman2Ian G. Hargraves3Angela L. Sivly4Juan P. Brito5Bruce Burnett6Claudia Zeballos‐Palacios7Mark Linzer8Takeki Suzuki9Alexander T. Lee10Haeshik Gorr11Elizabeth A. Jackson12Erik Hess13Sarah R. Brand‐McCarthy14Nilay D. Shah15Victor M. Montori16Knowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNThrombosis Clinic and Anticoagulation ServicesPark Nicollet Health Services St Louis Park MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNDepartment of Medicine Hennepin Healthcare, and the University of Minnesota Minneapolis MNDepartment of Medicine Krannert Institute of CardiologyIndiana University Indianapolis INDivision of Biomedical Statistics and Informatics Department of Health Sciences Research Mayo Clinic Rochester MNDepartment of Medicine Hennepin Healthcare, and the University of Minnesota Minneapolis MNDivision of Cardiovascular Disease Department of Internal Medicine University of Alabama at Birmingham Birmingham ALDepartment of Emergency Medicine for Vanderbilt University Medical Center Nashville TNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNKnowledge and Evaluation Research Unit Mayo Clinic Rochester MNBackground Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.https://www.ahajournals.org/doi/10.1161/JAHA.121.023048adherenceanticoagulationatrial fibrillationcommunicationconversation aiddecision aid |
| spellingShingle | Peter A. Noseworthy Megan E. Branda Marleen Kunneman Ian G. Hargraves Angela L. Sivly Juan P. Brito Bruce Burnett Claudia Zeballos‐Palacios Mark Linzer Takeki Suzuki Alexander T. Lee Haeshik Gorr Elizabeth A. Jackson Erik Hess Sarah R. Brand‐McCarthy Nilay D. Shah Victor M. Montori Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease adherence anticoagulation atrial fibrillation communication conversation aid decision aid |
| title | Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial |
| title_full | Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial |
| title_fullStr | Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial |
| title_full_unstemmed | Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial |
| title_short | Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial |
| title_sort | effect of shared decision making for stroke prevention on treatment adherence and safety outcomes in patients with atrial fibrillation a randomized clinical trial |
| topic | adherence anticoagulation atrial fibrillation communication conversation aid decision aid |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.121.023048 |
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