METEOR Think NIV Pilot

September 16, 2021 updated by: Timothy Girard, MD, MSCI, University of Pittsburgh

Maximizing Extubation Outcomes Through Educational and Organizational Research: Think NIV Pilot Study

This study will pilot test three strategies designed to speed implementation of preventive post-extubation noninvasive ventilation (NIV): one control strategy (traditional online continuing medical education) and two novel strategies (interprofessional education and just-in-time education).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During a one-month intervention period, the investigators will pilot test the educational strategies in three participating UPMC ICUs. Prior to receiving education, participants will be invited to complete a short online survey. Participants in the control group will be invited to complete a 30-minute online continuing education module, which will conclude with a survey. Participants in the interprofessional education group will be invited to attend a 90-minute, in-person, interprofessional education session that will occur in or near the participating ICU. A trained advance practice provider will provide participants in the just-in-time education group with 5-10 minutes of education in the ICU when the ICU team is rounding on a patient who is identified to be high risk for extubation failure. The just-in-time education may occur more than once per day, depending on the number of high-risk patients identified. All educational strategies will include content on the benefits of preventive post-extubation NIV, the indications and contraindications for preventive post-extubation NIV, and the value of working together as an interprofessional ICU team when implementing preventive post-extubation NIV. Each educational intervention will include a survey designed to determine the feasibility, acceptability, and preliminary impact of the educational strategies. The investigators will also directly observe instances of interprofessional and just-in-time education and conduct in-person interviews to assess these factors in a qualitative manner. Lastly, during the intervention period and the 6 months before and after the intervention period, the investigators will collect data from the electronic health record and analyze changes in percent of high-risk patients who receive preventive post-extubation NIV, reintubation rate, duration of mechanical ventilation, ventilator-associated pneumonia, and in-hospital mortality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Two study populations will be included.

Learners (population 1) will include:

  • frontline care providers, including physicians, advanced practice providers, nurses, and respiratory therapists
  • working in a participating ICU.

Frontline care providers will be excluded if they:

  • have not worked in their current UPMC ICU for more than one month prior to the current study
  • have not directly cared for a mechanically ventilated patient in a UPMC ICU during the three months preceding the current study.

Patients (population 2) will include:

  • mechanically ventilated patients
  • treated in the participating ICUs
  • surviving to extubation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Traditional online continuing education
Behavioral: Traditional online continuing education
30-minute, online, interactive, educational video describing the benefits of preventive post-extubation NIV, the indications and contraindications for preventive post-extubation NIV, and the value of working together as an interprofessional ICU team when implementing preventive post-extubation NIV
Active Comparator: Interprofessional education
Behavioral: Interprofessional education
One-time, 90-120-minute, in-person, interprofessional educational workshop consisting of a 30-minute didactic session and a 60-90-minute small group session
Active Comparator: Just-in-time education
Behavioral: Just-in-time education
"Just-in-time," point-of-care education provided by trained advanced practice providers who will be on-hand in the study ICU, where they will deliver the education at the bedside during rounds when a patient meets criteria for preventive post-extubation NIV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of ICU Team Members (Learners) Who Received Education
Time Frame: Up to 1 month
This implementation outcome measuring reach only applies to learner participants.
Up to 1 month
Learner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "I liked the way the information was presented." This outcome only applies to learner participants.
Up to 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation
Time Frame: Participants will be followed for the duration of their hospital admission, estimated to be 1-2 weeks
This implementation outcome only applies to patient participants.
Participants will be followed for the duration of their hospital admission, estimated to be 1-2 weeks
Learner Role Clarity (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "In assessing mechanically ventilated patients for potential extubation, I know what my responsibilities are." This outcome only applies to learner participants.
Up to 10 weeks
Learner Specialization (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "In assessing mechanically ventilated patients for potential extubation, I have knowledge that no other team member has." This outcome only applies to learner participants.
Up to 10 weeks
Learner Credibility (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "In making decisions about extubation, I am comfortable accepting procedural suggestions from other team members." This outcome only applies to learner participants.
Up to 10 weeks
Learner Coordination (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "In delivering care to patients in respiratory failure, our ICU team works together in a well-coordinated fashion." This outcome only applies to learner participants.
Up to 10 weeks
Learner Psychological Safety (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "I'm confident that when I make suggestions, other members of the care team will listen." This outcome only applies to learner participants.
Up to 10 weeks
Learner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)
Time Frame: Up to 10 weeks
Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "From now on, physicians in this ICU are likely to strike an appropriate balance between authority and openness to suggestion." This outcome only applies to learner participants.
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy D Girard, MD, MSCI, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19050064
  • U01HL143507 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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