Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway

被引:14
作者
Wang, Paul J. [1 ,2 ]
Lu, Ying [3 ]
Mahaffey, Kenneth W. [4 ]
Lin, Amy [3 ]
Morin, Daniel P. [5 ]
Sears, Samuel F. [6 ]
Chung, Mina K. [7 ]
Russo, Andrea M. [8 ]
Lin, Bryant [2 ]
Piccini, Jonathan [9 ]
Hills, Mellanie True [10 ]
Berube, Caroline [2 ]
Pundi, Krishna [2 ]
Baykaner, Tina [2 ]
Garay, Gotzone [2 ]
Lhamo, Karma [4 ]
Rice, Eli [4 ]
Pourshams, Idean A. [2 ]
Shah, Rushil [2 ]
Newswanger, Paul [4 ]
DeSutter, Katie [2 ]
Nunes, Julio Cesar [11 ]
Albert, Michelle A. [12 ]
Schulman, Kevin A. [2 ]
Heidenreich, Paul A. [2 ,13 ]
Bunch, T. Jared [14 ]
Sanders, Lee M. [15 ]
Turakhia, Mintu [2 ]
Verghese, Abraham [2 ]
Stafford, Randall S. [2 ]
机构
[1] 453 Quarry Rd, Stanford, CA 94305 USA
[2] Stanford Univ, Dept Med, Palo Alto, CA USA
[3] Stanford Univ, Dept Biomed Data Sci, Stanford, CA USA
[4] Stanford Univ, Stanford Ctr Clin Res, Dept Med, Stanford, CA USA
[5] Ochsner Hlth Care Dept Med, New Orleans, LA USA
[6] East Carolina Univ, Dept Psychol, Greenville, NC USA
[7] Cleveland Clin Fdn, Dept Med, Cleveland, OH USA
[8] Cooper HealthCare, Camden, NJ USA
[9] Duke Univ, Dept Med, Durham, NC USA
[10] iRhythm Technol, San Francisco, CA USA
[11] Yale Univ, Dept Psychiat, New Haven, CT USA
[12] Univ Calif San Francisco, Dept Med, San Francisco, CA USA
[13] Palo Alto Vet Adm Hlth Care Dept Med, Palo Alto, CA USA
[14] Univ Utah, Dept Med, Salt Lake City, UT USA
[15] Stanford Univ, Dept Pediat, Palo Alto, CA USA
来源
JOURNAL OF THE AMERICAN HEART ASSOCIATION | 2023年 / 12卷 / 03期
关键词
anticoagulants; anticoagulation; atrial fibrillation; decisional conflict; digital health; shared decision making; stroke; ANTICOAGULATION TREATMENT; ANTITHROMBOTIC THERAPY; ORAL ANTICOAGULANTS; AID; PREFERENCES; KNOWLEDGE; UNDERUSE; IMPACT;
D O I
10.1161/JAHA.122.028562
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Oral anticoagulation reduces stroke and disability in atrial fibrillation (AF) but is underused. We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing oral anticoagulation patient's decisional conflict as compared with usual care.Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE-AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). The digital AF shared decision-making toolkit was developed using patient-centered design with clear health communication principles (eg, meaningful images, limited text). Available in English and Spanish, the toolkit included the following: (1) a brief animated video; (2) interactive questions with answers; (3) a quiz to check on understanding; (4) a worksheet to be used by the patient during the encounter; and (5) an online guide for clinicians. The study population included English or Spanish speakers with nonvalvular AF and a CHA(2)DS(2)-VASc stroke score >= 1 for men or >= 2 for women. Participants were randomized in a 1:1 ratio to either usual care or the shared decision-making toolkit. The primary end point was the validated 16-item Decision Conflict Scale at 1 month. Secondary outcomes included Decision Conflict Scale at 6 months and the 10-item Decision Regret Scale at 1 and 6 months as well as a weighted average of Mann-Whitney U-statistics for both the Decision Conflict Scale and the Decision Regret Scale. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between December 18, 2019, and August 17, 2022. The mean patient age was 69 +/- 10 years (40% women, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA(2)DS(2)-VASc scores >= 3 (men) or >= 4 (women). The primary end point at 1 month showed a clinically meaningful reduction in decisional conflict: a 7-point difference in median scores between the 2 arms (16.4 versus 9.4; Mann-Whitney U-statistics=0.550; P=0.007). For the secondary end point of 1-month Decision Regret Scale, the difference in median scores between arms was 5 points in the direction of less decisional regret (P=0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for Decision Conflict Scale (P=0.060) and 0 points for Decision Regret Scale (P=0.35).Conclusions Implementation of a novel shared decision-making toolkit (; ) achieved significantly lower decisional conflict compared with usual care in patients with AF.
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页数:20
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