促进有发生心源性猝死风险的黑人患者进行共同决策：一项随机临床试验。
Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial.
机构信息
Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina (K.L.T., S.M.A.).
Duke Clinical Research Institute, Durham, North Carolina (A.S.K.).
出版信息
Ann Intern Med. 2023 May;176(5):615-623. doi: 10.7326/M22-2934. Epub 2023 Apr 4.
BACKGROUND
Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates.
OBJECTIVE
To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD.
DESIGN
Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973).
SETTING
Fourteen academic and community-based electrophysiology clinics in the United States.
PARTICIPANTS
Black adults with heart failure who were eligible for a primary prevention ICD.
INTERVENTION
An encounter-based video decision support tool or usual care.
MEASUREMENTS
The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians.
RESULTS
Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, -0.8 percentage point [95% CI, -13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, -2.6 [CI, -5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, -4.9 minutes [CI, -9.4 to -0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes.
LIMITATION
The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study.
CONCLUSION
A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation.
PRIMARY FUNDING SOURCE
Patient-Centered Outcomes Research Institute.
背景
心脏再同步治疗除颤器（ICD）植入的种族差异是多因素的，部分原因是拒绝率较高。
目的
评估针对符合 ICD 植入条件的黑人患者的视频决策支持工具的效果。
设计
多中心、随机临床试验，于 2016 年 9 月至 2020 年 4 月进行。（ClinicalTrials.gov：NCT02819973）。
地点
美国 14 个学术和社区电生理诊所。
参与者
符合原发性预防 ICD 植入条件的黑人成年心力衰竭患者。
干预措施
基于就诊的视频决策支持工具或常规护理。
测量
主要结果是 ICD 植入决策。其他结果包括患者知识、决策冲突、90 天内 ICD 植入、种族一致性对结果的影响以及患者与临床医生相处的时间。
结果
在 330 名随机分配的患者中，311 名患者提供了主要结局数据。在随机分配到视频组的患者中，同意植入 ICD 的比例为 58.6%，而常规护理组为 59.4%（差异，-0.8 个百分点[95%CI，-13.2 至 11.1 个百分点]）。与常规护理相比，视频组的参与者具有更高的平均知识得分（差异，0.7[CI，0.2 至 1.1]）和相似的决策冲突得分（差异，-2.6[CI，-5.7 至 0.4]）。90 天内 ICD 植入率为 65.7%，干预组之间无差异。随机分配到视频组的参与者与临床医生相处的时间少于常规护理组（平均 22.1 分钟与 27.0 分钟；差异，-4.9 分钟[CI，-9.4 至 -0.3 分钟]）。视频组和研究参与者之间的种族一致性并未影响研究结果。
局限性
医疗保险和医疗补助服务中心在研究期间实施了 ICD 植入共享决策的要求。
结论
基于视频的决策支持工具增加了患者的知识，但并未增加对 ICD 植入的同意。
主要资金来源
患者为中心的结果研究所。
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