The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
METEOR
2 other identifiers
interventional
13,018
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 18, 2026
February 1, 2026
2.9 years
August 29, 2022
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
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
90-day survival
90 days after initiating invasive mechanical ventilation
ICU length of stay
60 days after initiating invasive mechanical ventilation
Hospital length of stay
60 days after initiating invasive mechanical ventilation
- +5 more secondary outcomes
Study Arms (9)
Online education about risk-stratified post-extubation NIV/HFNC
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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.
Interprofessional education about post-extubation HFNC
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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.
Usual care
NO INTERVENTIONDuring this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies
Interventions
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 NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients
Preventive post-extubation HFNC for all eligible patients (without risk stratification)
A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits
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.
Eligibility Criteria
You may qualify if:
- All adults treated with invasive mechanical ventilation \>24 hours in participating ICUs
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
UPMC Carlisle
Carlisle, Pennsylvania, 17015, United States
UPMC Hanover
Hanover, Pennsylvania, 17331, United States
UPMC Harrisburg
Harrisburg, Pennsylvania, 17101, United States
UPMC Community Osteopathic
Harrisburg, Pennsylvania, 17109, United States
UPMC West Shore
Mechanicsburg, Pennsylvania, 17050, United States
UPMC East
Monroeville, Pennsylvania, 15146, United States
UPMC Jameson
New Castle, Pennsylvania, 16105, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215, United States
UPMC Mercy
Pittsburgh, Pennsylvania, 15219, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232, United States
UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
Related Publications (8)
Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline: Inspiratory Pressure Augmentation During Spontaneous Breathing Trials, Protocols Minimizing Sedation, and Noninvasive Ventilation Immediately After Extubation. Chest. 2017 Jan;151(1):166-180. doi: 10.1016/j.chest.2016.10.036. Epub 2016 Nov 3.
PMID: 27818331BACKGROUNDRochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
PMID: 28860265BACKGROUNDGranton D, Chaudhuri D, Wang D, Einav S, Helviz Y, Mauri T, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson CL, Jaber S, Brochard L, Trivedi V, Ricard JD, Goligher EC, Burns KEA, Rochwerg B. High-Flow Nasal Cannula Compared With Conventional Oxygen Therapy or Noninvasive Ventilation Immediately Postextubation: A Systematic Review and Meta-Analysis. Crit Care Med. 2020 Nov;48(11):e1129-e1136. doi: 10.1097/CCM.0000000000004576.
PMID: 32947472BACKGROUNDSang L, Nong L, Zheng Y, Xu Y, Chen S, Zhang Y, Huang Y, Liu X, Li Y. Effect of high-flow nasal cannula versus conventional oxygen therapy and non-invasive ventilation for preventing reintubation: a Bayesian network meta-analysis and systematic review. J Thorac Dis. 2020 Jul;12(7):3725-3736. doi: 10.21037/jtd-20-1050.
PMID: 32802452BACKGROUNDFernando SM, Tran A, Sadeghirad B, Burns KEA, Fan E, Brodie D, Munshi L, Goligher EC, Cook DJ, Fowler RA, Herridge MS, Cardinal P, Jaber S, Moller MH, Thille AW, Ferguson ND, Slutsky AS, Brochard LJ, Seely AJE, Rochwerg B. Noninvasive respiratory support following extubation in critically ill adults: a systematic review and network meta-analysis. Intensive Care Med. 2022 Feb;48(2):137-147. doi: 10.1007/s00134-021-06581-1. Epub 2021 Nov 25.
PMID: 34825256BACKGROUNDArgote L, Miron-Spektor E. Organizational learning: From experience to knowledge. Organization Science 2011;22:1123-37.
BACKGROUNDKasza J, Bowden R, Hooper R, Forbes AB. The batched stepped wedge design: A design robust to delays in cluster recruitment. Stat Med. 2022 Aug 15;41(18):3627-3641. doi: 10.1002/sim.9438. Epub 2022 May 21.
PMID: 35596691BACKGROUNDPrendergast NT, Kahn JM, Angus DC, Argote L, Barnes B, Chang CH, Graff S, Hess DR, Onyemekwu CA, Rak KJ, Russell JL, Seaman JB, Toth KM, Girard TD. Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial. BMJ Open. 2025 Oct 23;15(10):e108956. doi: 10.1136/bmjopen-2025-108956.
PMID: 41130691DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy D Girard, MD, MSCI
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Critical Care Medicine
Study Record Dates
First Submitted
August 29, 2022
First Posted
August 31, 2022
Study Start
March 1, 2023
Primary Completion
January 31, 2026
Study Completion
April 1, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Deidentified individual participant data will be made available to investigators who provide a methodologically sound proposal to achieve the aims of the approved proposal. Data will be available as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
- Access Criteria
- Proposals should be directed to Timothy Girard at timothy.girard@pitt.edu. To gain access, data requestors will need to sign a data use agreement.
The University of Pittsburgh will comply with applicable NIH guidelines on data sharing as published online. The investigators will make scientific data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Data will be shared as elements that meet or exceed the HIPAA Privacy Rule definition of "safe harbor de-identified" data, so that the rights and privacy of human subjects who participate in research are protected at all times. Principles and guidelines as outlined by the NIH Office of Technology Transfer will be observed in sharing all scientific resources.