Importance Suicide is a leading cause of deaths in the US. Although the emergency department (ED) is an opportune setting, ED-initiated interventions remain underdeveloped and understudied. Objective To determine if an ED process improvement package, with a subfocus on improving the implementation of collaborative safety planning, reduces subsequent suicide-related behaviors. Design, Setting, and Participants The Emergency Department Safety Assessment and Follow-up Evaluation 2 (ED-SAFE 2) trial, a stepped-wedge cluster randomized clinical trial conducted in 8 EDs across the US, used an interrupted time series design with three 12-month sequential phases: baseline, implementation, and maintenance. A random sample of 25 patients per month per site 18 years and older who screened positive on the Patient Safety Screener, a validated suicide risk screener, were included. The primary analyses focused on those who were discharged from the ED, while secondary analyses focused on all patients who screened positive, regardless of disposition. Data were collected on patients who presented for care from January 2014 to April 2018, and data were analyzed from April to December 2022. Interventions Each site received lean training and built a continuous quality improvement (CQI) team to evaluate the current suicide-related workflow in the ED, identify areas of improvement, and implement efforts to improve. Each site was expected to increase their universal suicide risk screening and implement collaborative safety planning for patients at risk of suicide who were discharged home from the ED. Site teams were centrally coached by engineers experienced in lean CQI and suicide prevention specialists. Main Outcomes and Measures The primary outcome was a composite comprising death by suicide or suicide-related acute health care visits, measured over a 6-month follow-up window. Results Across 3 phases, 2761 patient encounters were included in the analyses. Of these, 1391 (50.4%) were male, and the mean (SD) age was 37.4 (14.5) years. A total of 546 patients (19.8%) exhibited the suicide composite during the 6-month follow-up (9 [0.3%] died by suicide and 538 [19.5%] of a suicide-related acute health care visit). A significant difference was observed for the suicide composite outcome between the 3 phases (baseline, 216 of 1030 [21%]; implementation, 213 of 967 [22%]; maintenance, 117 of 764 [15.3%]; P = .001). The adjusted odds ratios of risk of the suicide composite during the maintenance phase was 0.57 (95% CI, 0.43-0.74) compared with baseline and 0.61 (0.46-0.79) compared with the implementation phase, which reflect a 43% and 39% reduction, respectively. Conclusions and Relevance In this multisite randomized clinical trial, using CQI methods to implement a department-wide change in suicide-related practices, including the implementation of a safety plan intervention, yielded a significant decrease in suicide behaviors in the maintenance period of the study. Trial Registration ClinicalTrials.gov Identifier: NCT02453243.

中文翻译：

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急诊科流程改进方案对预防自杀的影响：ED-SAFE 2 集群随机临床试验。

重要性 自杀是美国死亡的主要原因。尽管急诊室 (ED) 是一个合适的环境，但由 ED 发起的干预措施仍然不够完善和研究不足。目的 确定以改进协作安全计划的实施为次重点的急诊室流程改进方案是否可以减少随后的自杀相关行为。设计、设置和参与者 急诊科安全评估和随访评估 2 (ED-SAFE 2) 试验是一项在美国 8 个急诊室进行的阶梯式楔形整群随机临床试验，采用间断时间序列设计，包含 3 个 12 - 月连续阶段：基线、实施和维护。每个中心每月随机抽取 25 名 18 岁及以上患者，这些患者在患者安全筛查仪（一种经过验证的自杀风险筛查仪）上筛查呈阳性。主要分析集中于从急诊室出院的患者，而次要分析则集中于所有筛查呈阳性的患者，无论其性格如何。收集了 2014 年 1 月至 2018 年 4 月就诊的患者的数据，并分析了 2022 年 4 月至 2022 年 12 月的数据。 干预措施 每个中心都接受了精益培训，并建立了持续质量改进 (CQI) 团队来评估当前的自杀相关工作流程在 ED 中，确定需要改进的领域，并实施改进措施。预计每个站点将加强普遍的自杀风险筛查，并为从急诊室出院回家的有自杀风险的患者实施协作安全计划。现场团队由精益 CQI 经验丰富的工程师和自杀预防专家集中指导。主要结果和措施 主要结果是一个综合结果，包括自杀死亡或与自杀相关的急性医疗保健就诊，在 6 个月的随访窗口中进行测量。结果 在 3 个阶段中，分析中纳入了 2761 名患者。其中，1391 名 (50.4%) 为男性，平均 (SD) 年龄为 37.4 (14.5) 岁。在 6 个月的随访期间，共有 546 名患者 (19.8%) 表现出自杀综合症状（9 名患者 [0.3%] 死于自杀，538 名患者 [19.5%] 因自杀相关的紧急医疗就诊而死亡）。三个阶段之间的自杀综合结果存在显着差异（基线，1030 人中的 216 人 [21%]；实施，967 人中的 213 人 [22%]；维持，764 人中的 117 人 [15.3%]；P = .001） 。与基线相比，维持阶段调整后的自杀复合风险比值比为 0.57（95% CI，0.43-0.74），与实施阶段相比为 0.61（0.46-0.79），分别降低了 43% 和 39% ， 分别。结论和相关性 在这项多中心随机临床试验中，使用 CQI 方法在全部门范围内实施与自杀相关的做法的改变，包括实施安全计划干预，使研究维持期内的自杀行为显着减少。