The Maximizing Extubation outcomes Through Educational and Organizational Research (METEOR) Trial

项目摘要 近100万患者需要有创机械通气治疗急性呼吸衰竭， 美国每年。这些患者中的大多数将恢复到拔管的程度，但即使是那些 拔管后仍容易出现并发症和不良结果。多次高调 随机对照试验表明，两种预防性拔管后呼吸治疗- 无创通气（NIV）和高流量鼻插管氧气（HFNC）-可以防止复发 呼吸衰竭、重新插管和死亡。尽管有这些证据， 治疗仍然严重未得到充分利用，导致可预防的发病和死亡。为了解决这个 实施差距，我们建议进行最大化拔管结果通过教育 和组织研究（METEOR）试验，一项群集随机、阶梯楔形、2型混合试验 预防性拔管后NIV跨专业教育的实施效果观察 和HFNC，有和没有临床协议。我们设计的METEOR试验基于广泛的 初步研究，在此期间，我们确定了采用预防性拔管后的障碍 呼吸护理和试点测试跨专业教育作为ICU的实施策略。 这些研究表明，执行的一个主要障碍是缺乏共同的理解 关于这些疗法在跨专业ICU团队中的价值;基于理论的 旨在建立共同理解和支持的跨专业教育干预 团队成员之间的“交互记忆”既可行又可接受; 通过将其与临床规程联系起来，可以加强教育。在METEOR试验期间，我们将 将ICU随机分配到四种实施策略之一：主动控制，方案指导的护理， 跨专业教育，或协议指导的护理和跨专业教育相结合。 同时，我们将ICU随机分为两种临床策略，一种强调术后， 基于患者风险的拔管NIV或HFNC与强调所有拔管后HFNC 患者试验的具体目的是（1）测试跨专业教育的有效性 实施预防性、拔管后治疗;（2）比较两种方法的疗效 预防性拔管后治疗（NIV和HFNC）对以患者为中心的临床结局的影响，以及（3） 对审判过程和结果进行全面的定性评价，以便更好地 了解机制，确定哪些有效，哪些无效，并为更广泛的 传播研究结果。这些目标将共同提供关键的洞察力， 跨专业教育作为医院环境中的一项实施战略， 数十万急性呼吸衰竭患者的预后。

PROJECT SUMMARY Nearly one million patients require invasive mechanical ventilation for acute respiratory failure in the United States each year. Most of these patients will recover to the point of extubation, yet even those who are extubated remain vulnerable to complications and poor outcomes. Multiple high-profile randomized controlled trials have shown that two preventive post-extubation respiratory therapies— noninvasive ventilation (NIV) and high-flow nasal cannula oxygen (HFNC)—can prevent recurrent respiratory failure, reintubation, and death in this population. Despite this evidence, however, these therapies remain severely underutilized, leading to preventable morbidity and mortality. To address this implementation gap, we propose to conduct the Maximizing Extubation outcomes Through Educational and Organizational Research (METEOR) Trial, a cluster-randomized, stepped-wedge, type 2 hybrid effectiveness-implementation trial of interprofessional education about preventive post-extubation NIV and HFNC with and without clinical protocols. We designed the METEOR Trial based on extensive preliminary studies, during which we identified barriers to adoption of preventive post-extubation respiratory care and pilot tested interprofessional education as an implementation strategy in the ICU. These studies revealed that a major barrier to implementation is the lack of a shared understanding about the value of these therapies within the interprofessional ICU team; a theory-based interprofessional education intervention designed to create a shared understanding and support “transactive memory” among team members is both feasible and acceptable; and interprofessional education can be strengthened by linking it with a clinical protocol. During the METEOR Trial, we will randomize ICUs to one of four implementation strategies: an active control, protocol-directed care, interprofessional education, or a combination of protocol-directed care and interprofessional education. In parallel, we will randomize ICUs to one of two clinical strategies, one emphasizing either post- extubation NIV or HFNC based on patient risk vs. one emphasizing post-extubation HFNC for all patients. The specific aims of the trial are to (1) test the effectiveness of interprofessional education on the implementation of preventive, post-extubation therapies, (2) compare the effectiveness of two preventive, post-extubation therapies (NIV and HFNC) on patient-centered clinical outcomes, and (3) perform a comprehensive qualitative evaluation of the trial processes and outcomes in order to better understand mechanism, identify what worked and what didn’t, and set the stage for broader dissemination of the study findings. Together these aims will provide critical insight into the role of interprofessional education as an implementation strategy in hospital settings, leading to improved outcomes for hundreds of thousands of patients with acute respiratory failure.