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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

13018 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-04-30

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).

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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.

Conditions

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Acute Respiratory Failure Airway Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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:

1. A factorial design will be used to estimate the effects of two implementation strategies (IPE and a clinical protocol) separately as well as together.
2. 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.
3. 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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Traditional online education

Intervention Type BEHAVIORAL

A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits

Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients

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.

Group Type ACTIVE_COMPARATOR

Interprofessional education

Intervention Type BEHAVIORAL

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.

Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients

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.

Group Type ACTIVE_COMPARATOR

Clinical protocol

Intervention Type BEHAVIORAL

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.

Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients

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.

Group Type ACTIVE_COMPARATOR

Interprofessional education

Intervention Type BEHAVIORAL

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.

Clinical protocol

Intervention Type BEHAVIORAL

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.

Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients

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.

Group Type ACTIVE_COMPARATOR

Traditional online education

Intervention Type BEHAVIORAL

A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits

Preventive post-extubation high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation HFNC for all eligible patients (without risk stratification)

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.

Group Type ACTIVE_COMPARATOR

Interprofessional education

Intervention Type BEHAVIORAL

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.

Preventive post-extubation high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation HFNC for all eligible patients (without risk stratification)

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.

Group Type ACTIVE_COMPARATOR

Clinical protocol

Intervention Type BEHAVIORAL

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.

Preventive post-extubation high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation HFNC for all eligible patients (without risk stratification)

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.

Group Type ACTIVE_COMPARATOR

Interprofessional education

Intervention Type BEHAVIORAL

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.

Clinical protocol

Intervention Type BEHAVIORAL

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.

Preventive post-extubation high-flow nasal cannula oxygen (HFNC)

Intervention Type OTHER

Preventive post-extubation HFNC for all eligible patients (without risk stratification)

Usual care

During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Traditional online education

A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits

Intervention Type BEHAVIORAL

Interprofessional education

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.

Intervention Type BEHAVIORAL

Clinical protocol

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.

Intervention Type BEHAVIORAL

Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)

Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients

Intervention Type OTHER

Preventive post-extubation high-flow nasal cannula oxygen (HFNC)

Preventive post-extubation HFNC for all eligible patients (without risk stratification)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All adults treated with invasive mechanical ventilation \>24 hours in participating ICUs

Exclusion Criteria

* None

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Timothy Girard, MD, MSCI

Professor of Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy D Girard, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Carlisle

Carlisle, Pennsylvania, United States

Site Status

UPMC Hanover

Hanover, Pennsylvania, United States

Site Status

UPMC Harrisburg

Harrisburg, Pennsylvania, United States

Site Status

UPMC Community Osteopathic

Harrisburg, Pennsylvania, United States

Site Status

UPMC West Shore

Mechanicsburg, Pennsylvania, United States

Site Status

UPMC East

Monroeville, Pennsylvania, United States

Site Status