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

通过教育和组织研究 (METEOR) 试验最大限度地提高拔管效果

• 批准号: 10700877
• 负责人: Timothy D Girard
• 金额: $ 95.84万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700877
• 关键词: Acute respiratory failure; Address; Adoption; Adult; Area; Breathing; Cannulas; Caring; Cessation of life; Clinical; Clinical Protocols; Clinical Trials; Critical Care; Data; E-learning; Education; Educational Intervention; Effectiveness; Eligibility Determination; Evidence based practice; Funding; Grant; Hospital Mortality; Hospitals; Inpatients; Interview; Intubation; Learning; Life; Link; Mechanical ventilation; Medical; Memory; Morbidity - disease rate; Nature; Nose; Outcome; Oxygen; Patient risk; Patients; Persons; Population; Preventive; Process; Protocols documentation; Provider; Qualitative Evaluations; Randomized; Randomized, Controlled Trials; Recurrence; Research; Respiratory Failure; Respiratory Therapy; Risk; Role; Series; Surveys; Tube; United States; Work; acceptability and feasibility; active control; clinical center; compare effectiveness; contextual factors; design; effectiveness testing; effectiveness/implementation trial; face mask; high risk; implementation barriers; implementation strategy; implementation tool; improved outcome; innovation; insight; intervention refinement; member; mortality; novel; patient oriented; pilot test; prevent; respiratory; theories; therapy design; ventilation

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.

项目总结 近100万名患者需要有创机械通气治疗急性呼吸衰竭 美国每年都有。这些患者中的大多数都会恢复到拔管的程度，但即使是那些 那些拔管的人仍然容易出现并发症和不良结局。多个高调人物 随机对照试验表明，两种预防性拔管后呼吸疗法- 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，以及死亡。然而，尽管有这些证据，这些 治疗仍然严重得不到充分利用，导致可预防的发病率和死亡率。要解决这个问题 实施差距，我们建议通过教育实现最大限度的拔管成果 和组织研究(Meteor)试验，一种集群随机、阶梯楔形、类型2的混合 预防拔管后新生儿静脉感染的跨专业教育实施效果试验 和HFNC，有和没有临床方案。我们设计的流星试验是基于广泛的 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了跨专业教育作为ICU的一项实施战略。 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 团队成员的“交互记忆”是可行的，也是可以接受的；并且是跨专业的 教育可以通过将其与临床方案联系起来来加强。在流星试验期间，我们将 将ICU随机分为四种实施策略之一：主动控制、协议导向的护理、 跨专业教育，或礼仪指导的护理和跨专业教育的组合。 同时，我们将随机选择两种临床策略之一的ICU，一种强调后- 基于患者风险的拔管NIV或HFNC与强调拔管后HFNC对所有人的比较 病人。试验的具体目的是(1)测试跨专业教育的有效性 预防性、拔管后治疗的实施情况，(2)比较两种方法的效果 预防性、拔管后治疗(NIV和HFNC)对以患者为中心的临床结果的影响；以及(3) 对试验过程和结果进行全面的定性评估，以便更好地 了解机制，确定哪些有效，哪些无效，并为更广泛的发展奠定基础 传播研究结果。这些目标结合在一起，将为我们提供对 将跨专业教育作为医院环境中的一项实施战略，导致改进 数十万急性呼吸衰竭患者的预后。