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

Primary Purpose

Acute Respiratory Failure, Airway Extubation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional online education
Interprofessional education
Clinical protocol
Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)
Preventive post-extubation high-flow nasal cannula oxygen (HFNC)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Respiratory Failure focused on measuring Interprofessional Education, Clinical Protocols, Noninvasive Ventilation, Oxygen Inhalation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

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

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

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

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

Online education about post-extubation HFNC

Interprofessional education about post-extubation HFNC

Clinical protocol about post-extubation HFNC

Interprofessional education plus clinical protocol about post-extubation HFNC

Usual care

Arm 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.

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.

During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive 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.

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.

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.

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

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.

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

Outcomes

Primary Outcome Measures

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
In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)
Defined as the number of participants who died during hospitalization

Secondary Outcome Measures

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)
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
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)
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
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
Post-extubation respiratory failure
Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation
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
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
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
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

Full Information

First Posted
August 29, 2022
Last Updated
April 8, 2023
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05523479
Brief Title
The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
Acronym
METEOR
Official Title
The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Airway Extubation
Keywords
Interprofessional Education, Clinical Protocols, Noninvasive Ventilation, Oxygen Inhalation Therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
16800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online education about risk-stratified post-extubation NIV/HFNC
Arm Type
Active Comparator
Arm 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.
Arm Title
Interprofessional education about risk-stratified post-extubation NIV/HFNC
Arm Type
Active Comparator
Arm 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.
Arm Title
Clinical protocol about risk-stratified post-extubation NIV/HFNC
Arm Type
Active Comparator
Arm Description
During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.
Arm Title
Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC
Arm Type
Active Comparator
Arm 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.
Arm Title
Online education about post-extubation HFNC
Arm Type
Active Comparator
Arm 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.
Arm Title
Interprofessional education about post-extubation HFNC
Arm Type
Active Comparator
Arm 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.
Arm Title
Clinical protocol about post-extubation HFNC
Arm Type
Active Comparator
Arm Description
During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.
Arm Title
Interprofessional education plus clinical protocol about post-extubation HFNC
Arm Type
Active Comparator
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies
Intervention Type
Behavioral
Intervention Name(s)
Traditional online education
Intervention Description
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
Intervention Name(s)
Interprofessional education
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical protocol
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)
Intervention Description
Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients
Intervention Type
Other
Intervention Name(s)
Preventive post-extubation high-flow nasal cannula oxygen (HFNC)
Intervention Description
Preventive post-extubation HFNC for all eligible patients (without risk stratification)
Primary Outcome Measure Information:
Title
Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)
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
Time Frame
60 days after initiating invasive mechanical ventilation
Title
In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)
Description
Defined as the number of participants who died during hospitalization
Time Frame
60 days after initiating invasive mechanical ventilation
Secondary Outcome Measure Information:
Title
Number of eligible participants receiving care from providers who completed an implementation intervention
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)
Time Frame
Up to 3 years
Title
Use of post-extubation NIV or HFNC among eligible participants 6 months after the implementation intervention (IPE plus protocol) is fully deployed
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
Time Frame
6 months after the implementation intervention (IPE plus protocol) is fully deployed
Title
90-day survival
Description
Defined as time from initiating invasive mechanical ventilation to the date of death from any cause or last known follow-up (censored)
Time Frame
90 days after initiating invasive mechanical ventilation
Title
ICU length of stay
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
Time Frame
60 days after initiating invasive mechanical ventilation
Title
Hospital length of stay
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
Time Frame
60 days after initiating invasive mechanical ventilation
Title
Post-extubation respiratory failure
Description
Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation
Time Frame
60 days after initiating invasive mechanical ventilation
Title
Duration of 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
Time Frame
60 days after initiating invasive mechanical ventilation
Title
28-day ventilator-free days (VFDs)
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
Time Frame
28 days after initiating invasive mechanical ventilation
Title
Ventilator-associated events (VAEs)
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
Time Frame
Up to 60 days after initiating invasive mechanical ventilation
Title
Organ failure (daily SOFA)
Description
Defined as mean daily sequential organ failure assessment (SOFA) score from initiating invasive mechanical ventilation to up to 60 days later
Time Frame
Up to 60 days after initiating invasive mechanical ventilation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adults treated with invasive mechanical ventilation >24 hours in participating ICUs Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy D Girard, MD, MSCI
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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.
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
27818331
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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.
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The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial

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