Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway.
Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway.
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DOI：
10.1161/jaha.122.028562
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发表时间：
2023-02-07
影响因子：
5.4
通讯作者：
Stafford RS
中科院分区：
文献类型：
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作者：
Wang PJ;Lu Y;Mahaffey KW;Lin A;Morin DP;Sears SF;Chung MK;Russo AM;Lin B;Piccini J;Hills MT;Berube C;Pundi K;Baykaner T;Garay G;Lhamo K;Rice E;Pourshams IA;Shah R;Newswanger P;DeSutter K;Nunes JC;Albert MA;Schulman KA;Heidenreich PA;Bunch TJ;Sanders LM;Turakhia M;Verghese A;Stafford RS
口服抗凝可减少房颤（AF）的中风和残疾，但未得到充分利用。与常规治疗相比，我们评估了一种新型患者-临床共同决策（SDM）工具在减少口服抗凝患者决策冲突方面的效果。我们在一项多中心、随机、比较有效性的试验中设计并评估了一种新的数字决策辅助工具ENHANCE - AF（参与患者以帮助实现增加患者对房颤卒中预防的选择和参与）。数字AF共享决策工具包采用以患者为中心的设计，具有明确的健康沟通原则（例如，有意义的图像，有限的文本）。该工具包有英文和西班牙文两种版本，包括以下内容：(1)一个简短的动画视频；(2)互动问答；(3)检查理解的小测验；(4)供病人在会面时使用的工作表；(5)为临床医生提供在线指南。研究人群包括说英语或西班牙语的非瓣膜性房颤患者，男性CHA2DS2‐VASc卒中评分≥1或女性≥2。参与者按1:1的比例随机分配到常规护理或共享决策工具包。主要终点为1个月时的16项决策冲突量表。次要结果包括6个月时的决策冲突量表，1个月和6个月时的10项决策后悔量表，以及决策冲突量表和决策后悔量表的Mann-Whitney U统计加权平均值。在2019年12月18日至2022年8月17日期间，共有1001名参与者在美国的5个不同地点进行了登记和随访。患者平均年龄为69±10岁（40%为女性，16.9%为黑人，4.5%为西班牙裔，3.6%为亚洲人），50%的参与者CHA2DS2‐VASc评分≥3（男性）或≥4（女性）。1个月时的主要终点显示决策冲突有临床意义的减少：两组的中位评分相差7分（16.4比9.4;Mann-Whitney U - statistics=0.550； P=0.007）。对于1个月决策后悔量表的次要终点，两组间的中位数得分在较少决策后悔的方向上差异为5分（P=0.078）。治疗效果随着时间的推移而减弱：在6个月时，决策冲突量表的中位数差异为4.7分（P=0.060），决策后悔量表的中位数差异为0分（P=0.35）。实施一种新的共享决策工具包（afibguide.com; afibguide.com/clinician）与房颤患者的常规护理相比，显著降低了决策冲突。唯一标识符：NCT04096781。
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. 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 CHA2DS2‐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 CHA2DS2‐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). Implementation of a novel shared decision‐making toolkit (afibguide.com; afibguide.com/clinician) achieved significantly lower decisional conflict compared with usual care in patients with AF. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096781.