Clinical trial NCT05523479: The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
Official title: The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acute Respiratory Failure
Airway Extubation
Keywords: Interprofessional Education
Clinical Protocols
Noninvasive Ventilation
Oxygen Inhalation Therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-08-31
Enrollment: 13018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)
timeFrame: 60 days after initiating invasive mechanical ventilation
measure: In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)
timeFrame: 60 days after initiating invasive mechanical ventilation
Secondary outcomes:
measure: Number of eligible participants receiving care from providers who completed an implementation intervention
timeFrame: Up to 3 years
measure: Use of post-extubation NIV or HFNC among eligible participants 6 months after the implementation intervention (IPE plus protocol) is fully deployed
timeFrame: 6 months after the implementation intervention (IPE plus protocol) is fully deployed
measure: 90-day survival
timeFrame: 90 days after initiating invasive mechanical ventilation
measure: ICU length of stay
timeFrame: 60 days after initiating invasive mechanical ventilation
measure: Hospital length of stay
timeFrame: 60 days after initiating invasive mechanical ventilation
measure: Post-extubation respiratory failure
timeFrame: 60 days after initiating invasive mechanical ventilation
measure: Duration of mechanical ventilation
timeFrame: 60 days after initiating invasive mechanical ventilation
measure: 28-day ventilator-free days (VFDs)
timeFrame: 28 days after initiating invasive mechanical ventilation
measure: Ventilator-associated events (VAEs)
timeFrame: Up to 60 days after initiating invasive mechanical ventilation
measure: Organ failure (daily SOFA)
timeFrame: Up to 60 days after initiating invasive mechanical ventilation
Other outcomes:
Locations:
city: Carlisle
country: United States
facility: UPMC Carlisle
state: Pennsylvania
city: Hanover
country: United States
facility: UPMC Hanover
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Harrisburg
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Community Osteopathic
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: UPMC West Shore
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC East
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC Jameson
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC St. Margaret
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Mercy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant
state: Pennsylvania
city: York
country: United States
facility: UPMC Memorial
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Timothy D Girard, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
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.
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.
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.
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.
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.
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.