Emergency Department Safety Assessment and Follow-Up Evaluation (EDSAFE) Trial

描述（由申请人提供）： NIMH？的RFA-急诊医学部门的自杀预防认识到急诊科（艾德）作为一个重要的设置，以增加自杀检测和预防工作，但观察到，以证据为基础的实践指南不存在。作为回应，我们设计了艾德安全性评估和随访评价（EDSAFE）试验。两个相互关联的研究将进行使用准实验设计适合研究系统为基础的变化。这些研究将分享三个阶段的数据收集：治疗作为药物，单独筛查和干预。在每个阶段，将入组472例自杀患者（共1，416例），并使用多种方法随访12个月。 第一项研究，即筛选结果研究，将使用前两个阶段（作为药物治疗和单独筛选）收集的数据。首先，它将侧重于测试一种实用的方法来筛选艾德患者的自杀意念和行为，并将评估其对自杀检测，过程结果和自杀行为的影响。第二项研究是护理链评估研究，将使用最后两个阶段（单独筛查和干预）收集的数据。首先，它将评估多组分干预对自杀结果的影响。该干预措施将筛查、简短干预和转诊治疗（SBIRT）模式的概念基础与基于经验的自杀预防策略相结合。它将涉及（1）问题，转介，由治疗护士提供说服咨询，（2）将综合自杀管理方案纳入临床实践，（3）出院后电话咨询。我们的总体假设将使用这两项研究的组合进行测试。我们预测，筛查将改善自杀意念的检测，干预将提高护理质量，减少自杀结局。 我们的研究提供了以下创新和优势：（1）纳入了代表广泛地理区域、患者人口统计学和集水区（即，城市、郊区、农村）;（2）使用EMNet，它被NIH资助的临床研究网络的库存和评估（IECRN）授予最佳实践称号;（3）一种结构化的干预措施，以经验为基础，实用，灵活，足以适应全方位的自杀意念和行为;（4）分层的样本和计划的分析，以检查是否干预？的有效性不同的基础上基线自杀风险;（5）多方法的成果实现战略;和，（6）多成分的评估，这将有助于确定有效性，可行性和可持续性。

DESCRIPTION (provided by applicant): The NIMH?s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department (ED) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. In response, we have designed the ED Safety Assessment and Follow-up Evaluation (EDSAFE) trial. Two inter-related studies will be conducted using a quasi-experimental design appropriate for studying systems-based change. The studies will share three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 472 suicidal patients (1,416 total) will be enrolled and followed using multiple methods for 12 months. The first study, the Screening Outcome Study, will use data collected during the first two phases (Treatment as Usual and Screening Alone). Primarily, it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors. The second study, the Care-chain Evaluation Study, will use data collected during the last two phases (Screening Alone and Intervention). Primarily, it will evaluate the impact of a multi-component intervention on suicide outcomes. The intervention blends conceptual underpinnings from screening, brief intervention, and referral to treatment (SBIRT) models for health behaviors with empirically grounded strategies for suicide prevention. It will involve (1) Question, Refer, Persuade counseling provided by the treating nurse, (2) incorporation of a Comprehensive Suicide Management Protocol into clinical practice, and (3) post-discharge telephone counseling. Our overarching hypotheses will be tested using a combination of both studies. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes. Our studies offer the following innovations and strengths: (1) inclusion of eight general medical EDs representative of broad geographic regions, patient demographics, and catchment areas (i.e., urban, suburban, rural); (2) use of the EMNet, which was awarded a best practice designation by the NIH-funded Inventory and Evaluation of Clinical Research Networks (IECRN); (3) a structured intervention that is empirically based, practical, and flexible enough to accommodate a full spectrum of suicidal ideation and behavior; (4) stratification of the sample and planned analyses to examine whether the intervention?s effectiveness differs based upon baseline suicide risk; (5) a multi-method outcome attainment strategy; and, (6) a multi-component evaluation that will help determine effectiveness, feasibility, and sustainability.