U01HL159882

The Maximizing Extubation Outcomes through Educational and Organizational Research (METEOR) Trial - Project Summary

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, we propose to 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.

We designed the METEOR Trial based on extensive preliminary studies, during which we 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. Additionally, interprofessional education can be strengthened by linking it with a clinical protocol.

During the METEOR Trial, we 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, we will randomize ICUs to one of two clinical strategies, one emphasizing either post-extubation NIV or HFNC based on patient risk, versus one emphasizing post-extubation HFNC for all patients.

The specific aims of the trial are to:
1. Test the effectiveness of interprofessional education on the implementation of preventive, post-extubation therapies.
2. Compare the effectiveness of two preventive, post-extubation therapies (NIV and HFNC) on patient-centered clinical outcomes.
3. Perform a comprehensive qualitative evaluation of the trial processes and outcomes in order to better understand mechanism, identify what worked and what didn't, and set the stage for broader dissemination of the study findings.

Together, these aims will provide critical insight into the role of interprofessional education as an implementation strategy in hospital settings, leading to improved outcomes for hundreds of thousands of patients with acute respiratory failure.

University Of Pittsburgh - Of The Commonwealth System Of Higher Education

THE DIVISION OF LUNG DISEASES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE CAUSES, DIAGNOSIS, PREVENTION, AND TREATMENT OF LUNG DISEASES AND SLEEP DISORDERS. RESEARCH IS FUNDED THROUGH INVESTIGATOR-INITIATED AND INSTITUTE-INITIATED GRANT PROGRAMS AND THROUGH CONTRACT PROGRAMS IN AREAS INCLUDING ASTHMA, BRONCHOPULMONARY DYSPLASIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CYSTIC FIBROSIS, RESPIRATORY NEUROBIOLOGY, SLEEP AND CIRCADIAN BIOLOGY, SLEEP-DISORDERED BREATHING, CRITICAL CARE AND ACUTE LUNG INJURY, DEVELOPMENTAL BIOLOGY AND PEDIATRIC PULMONARY DISEASES, IMMUNOLOGIC AND FIBROTIC PULMONARY DISEASE, RARE LUNG DISORDERS, PULMONARY VASCULAR DISEASE, AND PULMONARY COMPLICATIONS OF AIDS AND TUBERCULOSIS. THE DIVISION IS RESPONSIBLE FOR MONITORING THE LATEST RESEARCH DEVELOPMENTS IN THE EXTRAMURAL SCIENTIFIC COMMUNITY AS WELL AS IDENTIFYING RESEARCH GAPS AND NEEDS, OBTAINING ADVICE FROM EXPERTS IN THE FIELD, AND IMPLEMENTING PROGRAMS TO ADDRESS NEW OPPORTUNITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Pennsylvania United States

State-Wide

Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01 - Clinical Trials Required) (RFA-HL-21-001)

Amendment Since initial award the total obligations have increased 595% from $621,164 to $4,315,155.