METEOR Think NIV Pilot

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052542
• Other study ID #: STUDY19050064
• Secondary ID: U01HL143507
• Status: Completed
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: September 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1328
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ferrer M, Sellarés 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. — View 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, Strøm 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. — View 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). pii: 1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ICU Team Members (Learners) Who Received Education	This implementation outcome measuring reach only applies to learner participants.	Up to 1 month
Primary	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.	Up to 10 weeks
Secondary	Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation	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
Secondary	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.	Up to 10 weeks
Secondary	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.	Up to 10 weeks
Secondary	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.	Up to 10 weeks
Secondary	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.	Up to 10 weeks
Secondary	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.	Up to 10 weeks
Secondary	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.	Up to 10 weeks