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

Not Applicable

• Conditions: Acute Respiratory Failure; Airway Extubation
• Interventions: Behavioral: Traditional online education; Behavioral: Interprofessional education; Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC); Behavioral: Clinical protocol; Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)

• Registration Number: NCT05523479
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2023-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 13018

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Clinical protocol about risk-stratified post-extubation NIV/HFNC	Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)	During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
Online education about risk-stratified post-extubation NIV/HFNC	Traditional online education	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.
Interprofessional education about risk-stratified post-extubation NIV/HFNC	Interprofessional education	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.
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC	Clinical protocol	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.
Interprofessional education about post-extubation HFNC	Preventive post-extubation high-flow nasal cannula oxygen (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.
Online education about risk-stratified post-extubation NIV/HFNC	Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (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.
Interprofessional education about risk-stratified post-extubation NIV/HFNC	Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (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.
Clinical protocol about risk-stratified post-extubation NIV/HFNC	Clinical protocol	During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC	Interprofessional education	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.
Online education about post-extubation HFNC	Traditional online education	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.
Online education about post-extubation HFNC	Preventive post-extubation high-flow nasal cannula oxygen (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.
Clinical protocol about post-extubation HFNC	Preventive post-extubation high-flow nasal cannula oxygen (HFNC)	During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
Interprofessional education plus clinical protocol about post-extubation HFNC	Clinical protocol	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.
Interprofessional education plus clinical protocol about post-extubation HFNC	Preventive post-extubation high-flow nasal cannula oxygen (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.
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC	Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (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.
Interprofessional education about post-extubation HFNC	Interprofessional education	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.
Clinical protocol about post-extubation HFNC	Clinical protocol	During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
Interprofessional education plus clinical protocol about post-extubation HFNC	Interprofessional education	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.

Primary Outcome Measures

Name	Time	Method
Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)	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)	60 days after initiating invasive mechanical ventilation	Defined as the number of participants who died during hospitalization

Secondary Outcome Measures

Name	Time	Method
Number of eligible participants receiving care from providers who completed an implementation intervention	Up to 3 years	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)
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	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
Hospital length of stay	60 days after initiating invasive mechanical ventilation	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
Organ failure (daily SOFA)	Up to 60 days after initiating invasive mechanical ventilation	Defined as mean daily sequential organ failure assessment (SOFA) score from initiating invasive mechanical ventilation to up to 60 days later
90-day survival	90 days after initiating invasive mechanical ventilation	Defined as time from initiating invasive mechanical ventilation to the date of death from any cause or last known follow-up (censored)
28-day ventilator-free days (VFDs)	28 days after initiating invasive mechanical ventilation	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
ICU length of stay	60 days after initiating invasive mechanical ventilation	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
Post-extubation respiratory failure	60 days after initiating invasive mechanical ventilation	Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation
Duration of mechanical ventilation	60 days after initiating invasive 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
Ventilator-associated events (VAEs)	Up to 60 days after initiating invasive mechanical ventilation	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

Trial Locations

Locations (15)

UPMC Carlisle; 🇺🇸 Carlisle, Pennsylvania, United States

UPMC Harrisburg; 🇺🇸 Harrisburg, Pennsylvania, United States

UPMC Hanover; 🇺🇸 Hanover, Pennsylvania, United States

UPMC Community Osteopathic; 🇺🇸 Harrisburg, Pennsylvania, United States

UPMC West Shore; 🇺🇸 Mechanicsburg, Pennsylvania, United States

UPMC East; 🇺🇸 Monroeville, Pennsylvania, United States

UPMC Jameson; 🇺🇸 New Castle, Pennsylvania, United States

UPMC Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC St. Margaret; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Mercy; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Shadyside; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Passavant; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Memorial; 🇺🇸 York, Pennsylvania, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States