Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.
Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.
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卒中预防的共同决策对房颤患者治疗依从性和安全性结局的影响：一项随机临床试验。
DOI：
10.1161/jaha.121.023048
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发表时间：
2022-01-18
影响因子：
5.4
通讯作者：
Montori, Victor M.
中科院分区：
文献类型：
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作者：
Noseworthy, Peter A.;Branda, Megan E.;Kunneman, Marleen;Hargraves, Ian G.;Sivly, Angela L.;Brito, Juan P.;Burnett, Bruce;Zeballos-Palacios, Claudia;Linzer, Mark;Suzuki, Takeki;Lee, Alexander T.;Gorr, Haeshik;Jackson, Elizabeth A.;Hess, Erik;Brand-McCarthy, Sarah R.;Shah, Nilay D.;Montori, Victor M.
关键词：
指南促进房颤患者抗凝的共同决策（SDM）。我们最近表明，在常规护理 (UC) 中添加会诊内 SDM 工具可以提高患者对决策的参与度和临床医生的满意度，而不会影响就诊时长。我们的目的是估计 SDM 工具的使用在多大程度上改变了对已决定的护理计划和临床安全终点的依从性。我们进行了一项多中心、会面水平、随机试验，评估在考虑开始或审查抗凝治疗的非瓣膜性心房颤动患者的临床会面（抗凝选择）期间使用 SDM 对话工具与不使用 SDM 对话工具的 UC 疗效。我们在入组后 10 个月进行了图表和药房审查，对随机化状态不知情，以评估主要依从性（服用抗凝剂并配药的患者比例）和次要依从性（使用直接口服抗凝药的治疗天数比例以及华法林治疗范围内的时间进行估计）。我们还指出任何中风、短暂性脑缺血发作、大出血或死亡作为安全终点。我们招募了 922 名可评估的患者（抗凝选择=463，UC=459），其中 814 名（88%）进行了药房和临床随访。我们发现，两组之间在主要依从性（SDM 组中 78% 的患者服用了首次处方，而 UC 组中为 81%）或次要抗凝治疗依从性（SDM 组中直接口服抗凝剂的覆盖天数百分比为 74.1%，UC 组为 71.6%；SDM 组中为 66.6%，而 UC 组中为 64.4%）方面没有差异；华法林治疗范围内的时间为 SDM 组中的 66.6%，而 UC 组中为 64.4%）。 SDM 组中 13% 的参与者和 UC 组中 14% 的参与者发生了安全结果（主要是出血）。在这项大型随机试验中，比较了 UC 和促进 SDM 对抗单独 UC 的工具，我们发现两组之间在主要或次要抗凝治疗依从性或临床安全性结果方面没有显着差异。网址：https://www.clinicaltrials.gov；唯一标识符：clinicaltrials.gov。标识符：NCT02905032。
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. 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. 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. URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.
影响因子：
2.9
作者：
Buhse S;Heller T;Kasper J;Mühlhauser I;Müller UA;Lehmann T;Lenz M
通讯作者：
Lenz M