METEOR Think NIV Pilot
Primary Purpose
Acute Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional online continuing education
Interprofessional education
Just-in-time education
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Failure focused on measuring Noninvasive ventilation, Education, Intensive care unit, Mechanical ventilation, Evidence-based practice
Eligibility Criteria
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
Sites / Locations
- UPMC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Traditional online continuing education
Interprofessional education
Just-in-time education
Arm Description
Outcomes
Primary Outcome Measures
Number of ICU Team Members (Learners) Who Received Education
This implementation outcome measuring reach only applies to learner participants.
Learner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)
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.
Secondary Outcome Measures
Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation
This implementation outcome only applies to patient participants.
Learner Role Clarity (Mean Scores on Relevant Survey Questions)
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.
Learner Specialization (Mean Scores on Relevant Survey Questions)
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.
Learner Credibility (Mean Scores on Relevant Survey Questions)
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.
Learner Coordination (Mean Scores on Relevant Survey Questions)
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.
Learner Psychological Safety (Mean Scores on Relevant Survey Questions)
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.
Learner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)
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.
Full Information
NCT ID
NCT04052542
First Posted
August 8, 2019
Last Updated
September 16, 2021
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04052542
Brief Title
METEOR Think NIV Pilot
Official Title
Maximizing Extubation Outcomes Through Educational and Organizational Research: Think NIV Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)
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
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Noninvasive ventilation, Education, Intensive care unit, Mechanical ventilation, Evidence-based practice
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1328 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional online continuing education
Arm Type
Active Comparator
Arm Title
Interprofessional education
Arm Type
Active Comparator
Arm Title
Just-in-time education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Traditional online continuing education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Interprofessional education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Just-in-time education
Intervention Description
"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
Primary Outcome Measure Information:
Title
Number of ICU Team Members (Learners) Who Received Education
Description
This implementation outcome measuring reach only applies to learner participants.
Time Frame
Up to 1 month
Title
Learner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation
Description
This implementation outcome only applies to patient participants.
Time Frame
Participants will be followed for the duration of their hospital admission, estimated to be 1-2 weeks
Title
Learner Role Clarity (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
Title
Learner Specialization (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
Title
Learner Credibility (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
Title
Learner Coordination (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
Title
Learner Psychological Safety (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
Title
Learner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)
Description
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.
Time Frame
Up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21765357
Citation
Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.
Results Reference
background
PubMed Identifier
19682735
Citation
Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
Results Reference
background
PubMed Identifier
27818331
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.
Results Reference
background
PubMed Identifier
28860265
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.
Results Reference
background
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METEOR Think NIV Pilot
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