A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an Established Incident Reporting System

项目摘要 在患者安全的一些领域取得了实质性进展，但用药失误和其他 每年，这些问题继续伤害着成千上万的患者。在其他高风险行业，自愿 事故报告被广泛用于提高安全性。事件报告也在医院中广泛使用，但 报告系统的运行并不是最佳的。护士提交大多数报告，但她们遇到了多重障碍 报告，包括不确定要报告什么，缺乏反馈，以及怀疑医院将如何使用 这些报告。护士每年提交数千份报告，但报告的事件风险较低 医疗差错的子集，报告提供的可操作的见解很少，也没有标准化的程序 正在进行后续调查。安全行动反馈和接洽(SAFE)循环有五个关键 旨在将医院事件报告系统转变为改善患者状况的有效工具的属性 安全性：获取护士关于解决哪些用药安全问题的意见；重点关注选定的高安全性问题 优先事件；提示护士在指定时间段内报告高优先级事件，并培训他们 编写信息量更大的报告；整合来自报告、调查和其他内部和 外部来源；并就发现的问题和缓解计划向护士提供反馈。 为了比较安全回路和现有事故报告系统的使用情况，调查人员将 年在锡达斯-西奈医学中心对20个急诊护理单元进行整群随机对照试验 洛杉矶，那里的1980名护士每年提供超过29.4万个病人日的护理。对应于三个 研究目的、结果衡量标准包括：(1)事件报告做法(护士报告高- 报告中描述的优先用药事件和致病因素数量)，(2)护士的态度 走向事件报告(美国人力资源部关于患者安全文化™的医院调查，特别是对 关于错误和事件报告频率的反馈和沟通)，以及(3) 高优先级用药事件(通过IHI触发工具病历审查方法确定)。分析 将比较实施干预和控制前后结果的变化 手臂。对护士的定性访谈安全环臂将提供对实施的洞察。 如果有效，安全循环将有几个好处：增加护士对报告的参与度， 制作更丰富的报告，使安全领导者能够了解问题并基于系统进行设计 更有效和更高效的解决方案，并降低用药差错率。反过来，接收 对问题的反馈和基于系统的解决方案将进一步改善护士对报告的看法。在……里面 除了给实施安全环路的医院带来当地好处外，这些变化还将产生次要影响 通过加强AHRQ患者安全组织的运作，使全国受益，这些组织依赖于事件 报告是洞察医院安全问题和潜在解决方案的重要来源。

Project Summary Substantial progress has been made in some areas of patient safety, but medication errors and other problems continue to harm many thousands of patients each year. In other high-risk industries, voluntary incident reporting is widely used to improve safety. Incident reporting is also widely used in hospitals, but the reporting systems do not function optimally. Nurses file most reports, but they experience multiple barriers to reporting, including uncertainty about what to report, lack of feedback, and doubt about how hospitals will use the reports. Nurses submit thousands of reports each year, but the reported incidents represent a lower-risk subset of medical errors, the reports impart few actionable insights, and no standardized procedures exist for conducting follow-up investigations. The Safety Action Feedback and Engagement (SAFE) Loop has five key attributes designed to transform hospital incident reporting systems into effective tools for improving patient safety: obtaining nurses’ input about which medication safety problems to address; focusing on selected high- priority events; prompting nurses to report high-priority events during a designated period and training them to write more informative reports; integrating information from reports, investigations, and other internal and external sources; and providing feedback to nurses on the problems identified and mitigation plans. To compare use of the SAFE Loop and an existing incident reporting system, the investigators will conduct a cluster randomized controlled trial of 20 acute care nursing units at Cedars-Sinai Medical Center in Los Angeles, where 1980 nurses provide over 294,000 patient-days of care per year. Corresponding to three study Aims, outcome measures include: (1) incident reporting practices (rates at which nurses report high- priority medication incidents and numbers of contributing factors described per report), (2) nurses’ attitudes toward incident reporting (AHRQ Hospital Survey on Patient Safety Culture™, particularly perceptions of feedback and communication about error and of the frequency with which events are reported), and (3) rates of high-priority medication events (determined via IHI Trigger Tool method of medical record review). Analyses will compare changes in outcomes between from before to after implementation in intervention and control arms. Qualitative interviews of nurses the SAFE Loop arm will provide insight into implementation. If effective, the SAFE Loop will have several benefits: increasing nurses’ engagement with reporting, producing more informative reports, enabling safety leaders to understand problems and design system-based solutions more effectively and more efficiently, and lowering rates of medication errors. In turn, receiving feedback about problems and system-based solutions will further improve nurses’ perceptions of reporting. In addition to the local benefits to hospitals that implement the SAFE Loop, these changes will create secondary benefits nationally by enhancing the functioning of AHRQ Patient Safety Organizations, which rely on incident reports as critical sources of insights into safety concerns in hospitals and potential solutions.