Clinical trial NCT04052542: METEOR Think NIV Pilot
Official title: Maximizing Extubation Outcomes Through Educational and Organizational Research: Think NIV Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Noninvasive ventilation
Education
Intensive care unit
Mechanical ventilation
Evidence-based practice
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-08-09
Enrollment: 1328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of ICU Team Members (Learners) Who Received Education
timeFrame: Up to 1 month
measure: Learner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation
timeFrame: Participants will be followed for the duration of their hospital admission, estimated to be 1-2 weeks
measure: Learner Role Clarity (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
measure: Learner Specialization (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
measure: Learner Credibility (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
measure: Learner Coordination (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
measure: Learner Psychological Safety (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
measure: Learner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Timothy D Girard, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.