## Protocol Section
### Identification Module
**NCT ID:** NCT05523479

**Acronym:** METEOR

**Brief Title:** The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial

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

#### Organization Study ID Info
**ID:** STUDY20100469
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
#### Secondary ID Infos
**ID:** U01HL159882
**Link:** https://reporter.nih.gov/quickSearch/U01HL159882
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-11

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-08-31
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-29
**Study First Submit QC Date:** 2022-08-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pittsburgh

#### Responsible Party

**Investigator Affiliation:** University of Pittsburgh

**Investigator Full Name:** Timothy Girard, MD, MSCI

**Investigator Title:** Professor of Critical Care Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Acute Respiratory Failure

- Airway Extubation

**Keywords:**

- Interprofessional Education

- Clinical Protocols

- Noninvasive Ventilation

- Oxygen Inhalation Therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

**Intervention 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:

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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 16800

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Traditional online education

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

**Label:** Online education about risk-stratified post-extubation NIV/HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Interprofessional education

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

**Label:** Interprofessional education about risk-stratified post-extubation NIV/HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.

**Intervention Names:**

- Behavioral: Clinical protocol

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

**Label:** Clinical protocol about risk-stratified post-extubation NIV/HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Behavioral: Interprofessional education

- Behavioral: Clinical protocol

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

**Label:** Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 5

**Description:** 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.

**Intervention Names:**

- Behavioral: Traditional online education

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

**Label:** Online education about post-extubation HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 6

**Description:** 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.

**Intervention Names:**

- Behavioral: Interprofessional education

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

**Label:** Interprofessional education about post-extubation HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 7

**Description:** During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.

**Intervention Names:**

- Behavioral: Clinical protocol

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

**Label:** Clinical protocol about post-extubation HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 8

**Description:** 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.

**Intervention Names:**

- Behavioral: Interprofessional education

- Behavioral: Clinical protocol

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

**Label:** Interprofessional education plus clinical protocol about post-extubation HFNC

**Type:** ACTIVE_COMPARATOR

#### Arm Group 9

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

**Label:** Usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Online education about post-extubation HFNC

- Online education about risk-stratified post-extubation NIV/HFNC

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

**Name:** Traditional online education

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Interprofessional education about post-extubation HFNC

- Interprofessional education about risk-stratified post-extubation NIV/HFNC

- Interprofessional education plus clinical protocol about post-extubation HFNC

- Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC

**Description:** 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.

**Name:** Interprofessional education

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Clinical protocol about post-extubation HFNC

- Clinical protocol about risk-stratified post-extubation NIV/HFNC

- Interprofessional education plus clinical protocol about post-extubation HFNC

- Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC

**Description:** 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.

**Name:** Clinical protocol

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- Clinical protocol about risk-stratified post-extubation NIV/HFNC

- Interprofessional education about risk-stratified post-extubation NIV/HFNC

- Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC

- Online education about risk-stratified post-extubation NIV/HFNC

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

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

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Clinical protocol about post-extubation HFNC

- Interprofessional education about post-extubation HFNC

- Interprofessional education plus clinical protocol about post-extubation HFNC

- Online education about post-extubation HFNC

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

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

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)

**Time Frame:** 60 days after initiating invasive mechanical ventilation

**Description:** Defined as the number of participants who died during hospitalization

**Measure:** In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)

**Time Frame:** 60 days after initiating invasive mechanical ventilation

#### Secondary Outcomes

**Description:** 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)

**Measure:** Number of eligible participants receiving care from providers who completed an implementation intervention

**Time Frame:** Up to 3 years

**Description:** 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

**Measure:** Use of post-extubation NIV or HFNC among eligible participants 6 months after the implementation intervention (IPE plus protocol) is fully deployed

**Time Frame:** 6 months after the implementation intervention (IPE plus protocol) is fully deployed

**Description:** Defined as time from initiating invasive mechanical ventilation to the date of death from any cause or last known follow-up (censored)

**Measure:** 90-day survival

**Time Frame:** 90 days after initiating invasive mechanical ventilation

**Description:** 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

**Measure:** ICU length of stay

**Time Frame:** 60 days after initiating invasive mechanical ventilation

**Description:** 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

**Measure:** Hospital length of stay

**Time Frame:** 60 days after initiating invasive mechanical ventilation

**Description:** Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation

**Measure:** Post-extubation respiratory failure

**Time Frame:** 60 days after initiating invasive mechanical ventilation

**Description:** 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

**Measure:** Duration of mechanical ventilation

**Time Frame:** 60 days after initiating invasive mechanical ventilation

**Description:** 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

**Measure:** 28-day ventilator-free days (VFDs)

**Time Frame:** 28 days after initiating invasive mechanical ventilation

**Description:** 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

**Measure:** Ventilator-associated events (VAEs)

**Time Frame:** Up to 60 days after initiating invasive mechanical ventilation

**Description:** Defined as mean daily sequential organ failure assessment (SOFA) score from initiating invasive mechanical ventilation to up to 60 days later

**Measure:** Organ failure (daily SOFA)

**Time Frame:** Up to 60 days after initiating invasive mechanical ventilation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* None

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pittsburgh

**Country:** United States

**Facility:** University of Pittsburgh

**State:** Pennsylvania

**Zip:** 15213

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pittsburgh

**Name:** Timothy D Girard, MD, MSCI

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**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.

### References Module

#### References

**Citation:** 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:** 27818331

**Citation:** Rochwerg 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:** 28860265

**Citation:** Granton 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:** 32947472

**Citation:** Sang 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:** 32802452

**Citation:** Fernando 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:** 34825256

**Citation:** Argote L, Miron-Spektor E. Organizational learning: From experience to knowledge. Organization Science 2011;22:1123-37.

**Citation:** Kasza 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:** 35596691

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: HIGH

- As Found: Respiratory Failure

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012131

- Term: Respiratory Insufficiency

### Misc Info Module

- Version Holder: 2024-05-24
