The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13,018
- 试验地点
- 17
- 主要终点
- Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)
研究概览
简要总结
The METEOR Trial will compare four implementation strategies-traditional online education, protocol-directed care, interprofessional education, and a combination of protocol-directed care and interprofessional education-to test the hypotheses that interprofessional education is superior to traditional online education as an implementation strategy in the intensive care unit (ICU) and the benefits of interprofessional education are increased when interprofessional education is paired with a clinical protocol. Additionally, the trial will also test the hypothesis that preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients are both superior to current clinical practice (i.e., conventional post-extubation oxygen therapy).
详细描述
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, the investigators will 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. The METEOR Trial was designed based on extensive preliminary studies, during which the investigators 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, the investigators 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, the investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults treated with invasive mechanical ventilation >24 hours in participating ICUs
排除标准
- 未提供
研究组 & 干预措施
Interprofessional education about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) (Other)
Clinical protocol about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Clinical protocol (Behavioral)
Online education about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Traditional online education (Behavioral)
Online education about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) (Other)
Interprofessional education about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Interprofessional education (Behavioral)
Clinical protocol about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) (Other)
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Interprofessional education (Behavioral)
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Clinical protocol (Behavioral)
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC
During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
干预措施: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) (Other)
Online education about post-extubation HFNC
During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Traditional online education (Behavioral)
Online education about post-extubation HFNC
During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) (Other)
Interprofessional education about post-extubation HFNC
During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Interprofessional education (Behavioral)
Interprofessional education about post-extubation HFNC
During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) (Other)
Clinical protocol about post-extubation HFNC
During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Clinical protocol (Behavioral)
Clinical protocol about post-extubation HFNC
During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) (Other)
Interprofessional education plus clinical protocol about post-extubation HFNC
During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Interprofessional education (Behavioral)
Interprofessional education plus clinical protocol about post-extubation HFNC
During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Clinical protocol (Behavioral)
Interprofessional education plus clinical protocol about post-extubation HFNC
During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
干预措施: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) (Other)
Usual care
During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies
结局指标
主要结局
Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)
时间窗: 60 days after initiating invasive mechanical ventilation
Defined the number of participants who received post-extubation NIV or HFNC divided by the number of participants eligible for post-extubation NIV or HFNC
In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)
时间窗: 60 days after initiating invasive mechanical ventilation
Defined as the number of participants who died during hospitalization
次要结局
- Number of eligible participants receiving care from providers who completed an implementation intervention(Up to 3 years)
- Use of post-extubation NIV or HFNC among eligible participants 6 months after the implementation intervention (IPE plus protocol) is fully deployed(6 months after the implementation intervention (IPE plus protocol) is fully deployed)
- Hospital length of stay(60 days after initiating invasive mechanical ventilation)
- Organ failure (daily SOFA)(Up to 60 days after initiating invasive mechanical ventilation)
- 90-day survival(90 days after initiating invasive mechanical ventilation)
- 28-day ventilator-free days (VFDs)(28 days after initiating invasive mechanical ventilation)
- ICU length of stay(60 days after initiating invasive mechanical ventilation)
- Post-extubation respiratory failure(60 days after initiating invasive mechanical ventilation)
- Duration of mechanical ventilation(60 days after initiating invasive mechanical ventilation)
- Ventilator-associated events (VAEs)(Up to 60 days after initiating invasive mechanical ventilation)
研究者
Timothy Girard, MD, MSCI
Professor of Critical Care Medicine
University of Pittsburgh