Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.

التفاصيل البيبلوغرافية
العنوان:	Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.
المؤلفون:	Noseworthy PA; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN.; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Mayo Clinic Rochester MN.; Heart Rhythm Services Department of Cardiovascular Diseases Mayo Clinic Rochester MN., Branda ME; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN.; Division of Biomedical Statistics and Informatics Department of Health Sciences Research Mayo Clinic Rochester MN.; Department of Biostatistics and Informatics Colorado School of Public Health University of Colorado-Denver Anschutz Medical Campus Aurora CO., Kunneman M; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN.; Biomedical Data Sciences Leiden University Medical Center Leiden the Netherlands., Hargraves IG; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN., Sivly AL; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN., Brito JP; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN., Burnett B; Thrombosis Clinic and Anticoagulation ServicesPark Nicollet Health Services St Louis Park MN., Zeballos-Palacios C; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN., Linzer M; Department of Medicine Hennepin Healthcare, and the University of Minnesota Minneapolis MN., Suzuki T; Department of Medicine Krannert Institute of CardiologyIndiana University Indianapolis IN., Lee AT; Division of Biomedical Statistics and Informatics Department of Health Sciences Research Mayo Clinic Rochester MN., Gorr H; Department of Medicine Hennepin Healthcare, and the University of Minnesota Minneapolis MN., Jackson EA; Division of Cardiovascular Disease Department of Internal Medicine University of Alabama at Birmingham Birmingham AL., Hess E; Department of Emergency Medicine for Vanderbilt University Medical Center Nashville TN., Brand-McCarthy SR; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN.; Department of Psychiatry and Psychology Mayo Clinic Rochester MN., Shah ND; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN., Montori VM; Knowledge and Evaluation Research Unit Mayo Clinic Rochester MN.
مؤلفون مشاركون:	SDM4AFib (Shared Decision‐Making for Atrial Fibrillation) Trial Investigators *
المصدر:	Journal of the American Heart Association [J Am Heart Assoc] 2022 Jan 18; Vol. 11 (2), pp. e023048. Date of Electronic Publication: 2022 Jan 13.
نوع المنشور:	Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
اللغة:	English
بيانات الدورية:	Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 101580524 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2047-9980 (Electronic) Linking ISSN: 20479980 NLM ISO Abbreviation: J Am Heart Assoc Subsets: MEDLINE
أسماء مطبوعة:	Original Publication: Oxford : Wiley-Blackwell
مواضيع طبية MeSH:	Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Stroke/complications , Stroke/prevention & control, Anticoagulants/adverse effects ; Hemorrhage/chemically induced ; Humans ; Patient Participation ; Warfarin/adverse effects
مستخلص:	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.
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معلومات مُعتمدة:	R01 HL131535 United States HL NHLBI NIH HHS
فهرسة مساهمة:	Investigator: VM Montori; ME Branda; JP Brito; M Kunneman; I Hargraves; AL Sivly; K Fleming; B Burnett; M Linzer; H Gorr; E Jackson; E Hess; T Suzuki; J Hamilton; PA Noseworthy; H Gorr; A Haffke; M Linzer; J Muegge; S Poplau; B Simpson; M Vang; M Wambua; J Anderson; E Behnken; F Bellolio; JP Brito; R Cabalka; M Ferrara; K Fleming; R Giblon; I Hargraves; J Inselman; M Kunneman; A LeBlanc; A Lee; V Montori; P Noseworthy; M Olive; P Organick; N Shah; A Sivly; G Spencer-Bonilla; A Stier; A Thota; H Ting; D Vanmeter; C Zeballos-Palacios; P Nicollet; C Abullarade; B Burnett; L Harvey; S Keune; E Jackson; E Hess; T Smith; S Stephens; B Barksdale; J Hamilton; T Hickey; R Peters; M Price; T Suzuki; C Watson; D Wolfe; G Guyatt; B Haynes; G Tomlinson; P Daniels; B Gersh; E Hess; T Jaeger; R McBane; P Noseworthy Keywords: adherence; anticoagulation; atrial fibrillation; communication; conversation aid; decision aid; shared decision‐making
سلسلة جزيئية:	ClinicalTrials.gov NCT02905032
المشرفين على المادة:	0 (Anticoagulants) 5Q7ZVV76EI (Warfarin)
تواريخ الأحداث:	Date Created: 20220113 Date Completed: 20220408 Latest Revision: 20220716
رمز التحديث:	20221213
مُعرف محوري في PubMed:	PMC9238511
DOI:	10.1161/JAHA.121.023048
PMID:	35023356
قاعدة البيانات:	MEDLINE

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تدمد:	2047-9980
DOI:	10.1161/JAHA.121.023048