Departments of Anesthesia and Intensive Care, Hospices Civils of Lyon, Lyon, France.
Centre Lyonnais d'Enseignement par Simulation en Santé (CLESS, high fidelity medical simulation center), SAMSEI, Lyon, France.
Trials. 2022 Feb 2;23(1):106. doi: 10.1186/s13063-022-06040-2.
Morbidity and Mortality conference provides the necessary improvement measures for patient safety. However, they are an underused resource mainly because the conclusions to be drawn from the discussion and their implications for practice are not always well integrated by inpatient care teams. We therefore propose in this study two interventions to optimise their effectiveness: a passive feedback with wide dissemination by e-mail and/or on paper of the results of the Morbidity and Mortality conference to inpatient care teams and an active feedback with in situ inter-professional simulation-training programme in which scenarios will be based on cases studied in Morbidity and Mortality conference. In the present study, we hypothesise that the greatest reduction the occurrence of adverse event will be in the active feedback arm.
A cluster randomised controlled study will be performed at four study sites. The unit of randomisation is wards within the study sites. Fifteen wards will be randomly assigned to passive feedback, active feedback, or a standard MMC (control arm). Passive feedback and active feedback arms will be compared to standard arm in terms of occurrence of adverse events. The trigger tool methodology used to identify adverse events is a retrospective review of inpatient records using "triggers": an adverse event is defined as a patient's stay with at least one positive trigger.
The in situ simulation training based on cases processed in Morbidity and Mortality conference is built according to the main topics identified for the successful implementation of healthcare simulation in patient safety programmes: technical skills, nontechnical skills, assessment, effectiveness, and system probing. The in situ simulation-training programme conducted as part of the study has the potential to improve patient safety during hospitalisation. We therefore expect the greatest reduction in the occurrence of adverse events in patients hospitalised in the active feedback arm. This expected result would have a direct impact on patient safety and would place in situ simulation at the highest level of the Kirkpatrick model.
Clinicaltrials.gov NCT02771613. Registered on May 12, 2016. All items from the WHO Trial Registration Data Set can be found within the protocol.
发病率和死亡率会议为患者安全提供了必要的改进措施。然而，它们是一种未充分利用的资源，主要是因为讨论得出的结论及其对实践的影响并不总是被住院护理团队很好地整合。因此，我们在这项研究中提出了两种干预措施来优化其效果：通过电子邮件和/或纸质形式向住院护理团队广泛传播被动反馈，将发病率和死亡率会议的结果广泛传播，并进行现场跨专业模拟培训计划的主动反馈，其中情景将基于发病率和死亡率会议中研究的病例。在本研究中，我们假设主动反馈组不良事件的发生率将降低最大。
将在四个研究地点进行一项集群随机对照研究。随机分组的单位是研究地点内的病房。将 15 个病房随机分配到被动反馈、主动反馈或标准 MMC（对照组）中。将被动反馈和主动反馈臂与标准臂进行比较，以评估不良事件的发生情况。用于识别不良事件的触发工具方法是使用“触发器”回顾性审查住院病历：一个不良事件被定义为患者的住院时间至少有一个阳性触发器。
基于发病率和死亡率会议处理的病例构建的现场模拟培训是根据成功实施医疗保健模拟在患者安全计划中的主要主题构建的：技术技能、非技术技能、评估、有效性和系统探测。作为研究一部分进行的现场模拟培训计划有可能提高住院期间患者的安全性。因此，我们预计在主动反馈臂住院的患者中不良事件的发生率将降低最大。这一预期结果将直接影响患者的安全，并将现场模拟置于柯克帕特里克模型的最高水平。
Clinicaltrials.gov NCT02771613。于 2016 年 5 月 12 日注册。WHO 试验注册数据集的所有项目都可以在方案中找到。
