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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial

Conditions
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Acute Respiratory Failure, Airway Extubation

Intervention / Treatment
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* Behavioral: Traditional online education
* Behavioral: Interprofessional education
* Behavioral: Clinical protocol
* Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)
* Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults treated with invasive mechanical ventilation >24 hours in participating ICUs Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The METEOR Trial is a batched stepped wedge cluster randomized type 2 hybrid implementation-effectiveness trial. ICUs are randomized rather than individuals, and each ICU will cross over from control to intervention at a randomized timepoint. The trial will employ three variations on the traditional stepped wedge design: A factorial design will be used to estimate the effects of two implementation strategies (IPE and a clinical protocol) separately as well as together. A concurrent design will be used to compare two post-extubation strategies (HFNC for all patients vs. NIV for high-risk patients and HFNC for low-risk patients) with conventional post-extubation oxygen therapy and with each other. A batched design allows for the recruitment of clusters (i.e., ICUs) throughout the duration of the trial rather than requiring that all clusters commence participation in the trial at the same time.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online education about risk-stratified post-extubation NIV/HFNC<br>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. | Behavioral: Traditional online education<br>* A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits<br>Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients<br>|
| Active Comparator: Interprofessional education about risk-stratified post-extubation NIV/HFNC<br>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. | Behavioral: Interprofessional education<br>* Interprofessional education (IPE) consists of both classroom-based IPE and just-in-time IPE. In classroom-based IPE, a trained physician educator with content expertise who works in the ICU leads a 60-to-90-minute, in-person, IPE workshop consisting of a 30-minute didactic session and a 30-to-60-minute small group session, during which participants work together to apply the content to authentic cases. The workshops, which are designed according to modern principles of adult learning and IPE, present the rationale and evidence supporting the preventive, post-extubation therapies. They are specifically designed to foster authenticity, reinforce role identity, and relate the content to life experience. In just-in-time IPE, trained local champions meet with the interprofessional ICU team each morning to identify eligible patients and, as needed, briefly review the evidence supporting proper use of the assigned preventive, post-extubation strategy.<br>Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients<br>|
| Active Comparator: Clinical protocol about risk-stratified post-extubation NIV/HFNC<br>During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. | Behavioral: Clinical protocol<br>* An adequately explicit protocol provides specific rules for use of the preventive, post-extubation therapy based on patient data. A ready-to-customize version of the protocol with instructions to work with key local stakeholders to revise the protocol, accounting for local needs and resources, is provided. After local customization, a local champion then disseminates the protocol based on local practices.<br>Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients<br>|
| Active Comparator: Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC<br>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. | Behavioral: Interprofessional education<br>* Interprofessional education (IPE) consists of both classroom-based IPE and just-in-time IPE. In classroom-based IPE, a trained physician educator with content expertise who works in the ICU leads a 60-to-90-minute, in-person, IPE workshop consisting of a 30-minute didactic session and a 30-to-60-minute small group session, during which participants work together to apply the content to authentic cases. The workshops, which are designed according to modern principles of adult learning and IPE, present the rationale and evidence supporting the preventive, post-extubation therapies. They are specifically designed to foster authenticity, reinforce role identity, and relate the content to life experience. In just-in-time IPE, trained local champions meet with the interprofessional ICU team each morning to identify eligible patients and, as needed, briefly review the evidence supporting proper use of the assigned preventive, post-extubation strategy.<br>Behavioral: Clinical protocol<br>* An adequately explicit protocol provides specific rules for use of the preventive, post-extubation therapy based on patient data. A ready-to-customize version of the protocol with instructions to work with key local stakeholders to revise the protocol, accounting for local needs and resources, is provided. After local customization, a local champion then disseminates the protocol based on local practices.<br>Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients<br>|
| Active Comparator: Online education about post-extubation HFNC<br>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. | Behavioral: Traditional online education<br>* A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits<br>Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation HFNC for all eligible patients (without risk stratification)<br>|
| Active Comparator: Interprofessional education about post-extubation HFNC<br>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. | Behavioral: Interprofessional education<br>* Interprofessional education (IPE) consists of both classroom-based IPE and just-in-time IPE. In classroom-based IPE, a trained physician educator with content expertise who works in the ICU leads a 60-to-90-minute, in-person, IPE workshop consisting of a 30-minute didactic session and a 30-to-60-minute small group session, during which participants work together to apply the content to authentic cases. The workshops, which are designed according to modern principles of adult learning and IPE, present the rationale and evidence supporting the preventive, post-extubation therapies. They are specifically designed to foster authenticity, reinforce role identity, and relate the content to life experience. In just-in-time IPE, trained local champions meet with the interprofessional ICU team each morning to identify eligible patients and, as needed, briefly review the evidence supporting proper use of the assigned preventive, post-extubation strategy.<br>Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation HFNC for all eligible patients (without risk stratification)<br>|
| Active Comparator: Clinical protocol about post-extubation HFNC<br>During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients. | Behavioral: Clinical protocol<br>* An adequately explicit protocol provides specific rules for use of the preventive, post-extubation therapy based on patient data. A ready-to-customize version of the protocol with instructions to work with key local stakeholders to revise the protocol, accounting for local needs and resources, is provided. After local customization, a local champion then disseminates the protocol based on local practices.<br>Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation HFNC for all eligible patients (without risk stratification)<br>|
| Active Comparator: Interprofessional education plus clinical protocol about post-extubation HFNC<br>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. | Behavioral: Interprofessional education<br>* Interprofessional education (IPE) consists of both classroom-based IPE and just-in-time IPE. In classroom-based IPE, a trained physician educator with content expertise who works in the ICU leads a 60-to-90-minute, in-person, IPE workshop consisting of a 30-minute didactic session and a 30-to-60-minute small group session, during which participants work together to apply the content to authentic cases. The workshops, which are designed according to modern principles of adult learning and IPE, present the rationale and evidence supporting the preventive, post-extubation therapies. They are specifically designed to foster authenticity, reinforce role identity, and relate the content to life experience. In just-in-time IPE, trained local champions meet with the interprofessional ICU team each morning to identify eligible patients and, as needed, briefly review the evidence supporting proper use of the assigned preventive, post-extubation strategy.<br>Behavioral: Clinical protocol<br>* An adequately explicit protocol provides specific rules for use of the preventive, post-extubation therapy based on patient data. A ready-to-customize version of the protocol with instructions to work with key local stakeholders to revise the protocol, accounting for local needs and resources, is provided. After local customization, a local champion then disseminates the protocol based on local practices.<br>Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)<br>* Preventive post-extubation HFNC for all eligible patients (without risk stratification)<br>|
| No Intervention: Usual care<br>During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome) | 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 | 60 days after initiating invasive mechanical ventilation | 
| In-hospital mortality truncated at 60 days from intubation (primary clinical outcome) | Defined as the number of participants who died during hospitalization | 60 days after initiating invasive mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eligible participants receiving care from providers who completed an implementation intervention | Defined as the total number of participants who received care from ICU providers (physicians, nurses, and/or respiratory therapists) who completed an implementation intervention (traditional online education, interprofessional education, and/or clinical protocol) | 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 | 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 during the one-month period beginning 6 months after the implementation intervention (IPE plus protocol) is fully deployed | 6 months after the implementation intervention (IPE plus protocol) is fully deployed | 
| 90-day survival | Defined as time from initiating invasive mechanical ventilation to the date of death from any cause or last known follow-up (censored) | 90 days after initiating invasive mechanical ventilation | 
| ICU length of stay | Defined as time from the time of initiating invasive mechanical ventilation to successful discharge from the ICU, where successful indicates that discharge was followed by at least 48 hours alive without ICU readmission | 60 days after initiating invasive mechanical ventilation | 
| Hospital length of stay | Defined as time from the time of initiating invasive mechanical ventilation to successful hospital discharge, where successful indicates that discharge was followed by at least 48 hours alive without hospital readmission | 60 days after initiating invasive mechanical ventilation | 
| Post-extubation respiratory failure | Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation | 60 days after initiating invasive mechanical ventilation | 
| Duration of mechanical ventilation | Defined as time from the time of initiating invasive mechanical ventilation to successful extubation, where successful indicates that extubation was followed by at least 48 hours alive without reintubation | 60 days after initiating invasive mechanical ventilation | 
| 28-day ventilator-free days (VFDs) | Defined as the number of days a participant was breathing without assistance from the day they of intubation (initiating invasive mechanical ventilation) to 28 days later, where breathing without assistance indicates that discontinuation of assisted breathing was followed by at least 48 hours alive without reintubation | 28 days after initiating invasive mechanical ventilation | 
| Ventilator-associated events (VAEs) | Defined as the number of participants who have a VAE according to Centers of Disease Control and Prevention (CDC) criteria divided by the number of participants who received invasive mechanical ventilation | Up to 60 days after initiating invasive mechanical ventilation | 
| Organ failure (daily SOFA) | Defined as mean daily sequential organ failure assessment (SOFA) score from initiating invasive mechanical ventilation to up to 60 days later | Up to 60 days after initiating invasive mechanical ventilation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interprofessional Education, Clinical Protocols, Noninvasive Ventilation, Oxygen Inhalation Therapy