Skip to content

METEOR Think NIV Pilot

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04052542
Enrollment
1328
Registered
2019-08-09
Start date
2019-08-28
Completion date
2019-11-20
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Noninvasive ventilation, Education, Intensive care unit, Mechanical ventilation, Evidence-based practice

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.

Interventions

BEHAVIORALTraditional 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

BEHAVIORALInterprofessional 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

BEHAVIORALJust-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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of ICU Team Members (Learners) Who Received EducationUp to 1 monthThis implementation outcome measuring reach only applies to learner participants.
Learner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)Up to 10 weeksUsing 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

MeasureTime frameDescription
Learner Specialization (Mean Scores on Relevant Survey Questions)Up to 10 weeksUsing 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)Up to 10 weeksUsing 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.
Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive VentilationParticipants will be followed for the duration of their hospital admission, estimated to be 1-2 weeksThis implementation outcome only applies to patient participants.
Learner Psychological Safety (Mean Scores on Relevant Survey Questions)Up to 10 weeksUsing 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)Up to 10 weeksUsing 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.
Learner Coordination (Mean Scores on Relevant Survey Questions)Up to 10 weeksUsing 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 Role Clarity (Mean Scores on Relevant Survey Questions)Up to 10 weeksUsing 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Traditional Online Continuing Education Group - Pre-education
Patients admitted during the 6 months prior to the education period to the ICU that would later participate in traditional online continuing education.
116
Traditional Online Continuing Education Group - During Education
Patients admitted during the one-month education period to the ICU that participated in traditional online continuing education.
28
Traditional Online Continuing Education Group - Post-education
Patients admitted during the 6 months after the education period to the ICU that participated in traditional online continuing education.
146
Interprofessional Education Group - Pre-education
Patients admitted during the 6 months prior to the education period to the ICU that would later participate in interprofessional education.
188
Interprofessional Education - During Education
Patients admitted during the one-month education period to the ICU that participated in interprofessional education.
24
Interprofessional Education Group - Post-education
Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education.
183
Just-in-time Education - Pre-education
Patients admitted during the 6 months prior to the education period to the ICU that would later participate in just-in-time education.
275
Just-in-time Education Group - During Education
Patients admitted during the one-month education period to the ICU that participated in just-in-time education.
27
Just-in-time Education Group - Post-education
Patients admitted during the 6 months after the education period to the ICU that participated in just-in-time education.
276
Traditional Online Continuing Education Group - Learners
Learners who participated in traditional online continuing education
22
Interprofessional Education Group - Learners
Learners who participated in interprofessional education
31
Just-in-time Education Group - Learners
Learners who participated in just-in-time education
12
Total1,328

Baseline characteristics

CharacteristicTraditional Online Continuing Education Group - During EducationTraditional Online Continuing Education Group - Post-educationInterprofessional Education Group - Pre-educationInterprofessional Education - During EducationInterprofessional Education Group - Post-educationTraditional Online Continuing Education Group - Pre-educationJust-in-time Education - Pre-educationJust-in-time Education Group - During EducationJust-in-time Education Group - Post-educationTotal
Age, Continuous79 years74 years74 years77 years75 years72 years70 years69 years71 years73 years
Race/Ethnicity, Customized
Race
Black
2 Participants20 Participants6 Participants0 Participants7 Participants10 Participants20 Participants4 Participants56 Participants125 Participants
Race/Ethnicity, Customized
Race
Other
3 Participants6 Participants5 Participants1 Participants6 Participants10 Participants19 Participants2 Participants34 Participants86 Participants
Race/Ethnicity, Customized
Race
White
23 Participants120 Participants177 Participants23 Participants170 Participants96 Participants236 Participants21 Participants186 Participants1052 Participants
Sequential Organ Failure Assessment (SOFA) Score7 units on a scale7 units on a scale8 units on a scale9 units on a scale8 units on a scale9 units on a scale7 units on a scale10 units on a scale5 units on a scale7 units on a scale
Sex: Female, Male
Female
20 Participants71 Participants85 Participants10 Participants100 Participants52 Participants165 Participants7 Participants87 Participants597 Participants
Sex: Female, Male
Male
8 Participants75 Participants103 Participants14 Participants83 Participants64 Participants110 Participants20 Participants189 Participants666 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
deaths
Total, all-cause mortality
44 / 11610 / 2861 / 14637 / 1888 / 2458 / 183130 / 2755 / 2757 / 2760 / 00 / 00 / 0
other
Total, other adverse events
0 / 1160 / 280 / 1460 / 1880 / 240 / 1830 / 2750 / 270 / 2760 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 1160 / 280 / 1460 / 1880 / 240 / 1830 / 2750 / 270 / 2760 / 00 / 00 / 0

Outcome results

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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)4.2 score on a scaleStandard Deviation 0.7
Interprofessional Education Group - LearnersLearner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)4.8 score on a scaleStandard Deviation 0.6
Just-in-time Education Group - LearnersLearner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)3.4 score on a scaleStandard Deviation 1
Primary

Number of ICU Team Members (Learners) Who Received Education

This implementation outcome measuring reach only applies to learner participants.

Time frame: Up to 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Traditional Online Continuing Education Group - LearnersNumber of ICU Team Members (Learners) Who Received Education22 Participants
Interprofessional Education Group - LearnersNumber of ICU Team Members (Learners) Who Received Education31 Participants
Just-in-time Education Group - LearnersNumber of ICU Team Members (Learners) Who Received Education12 Participants
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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Coordination (Mean Scores on Relevant Survey Questions)4.3 score on a scaleStandard Deviation 0.7
Interprofessional Education Group - LearnersLearner Coordination (Mean Scores on Relevant Survey Questions)4.9 score on a scaleStandard Deviation 0.3
Just-in-time Education Group - LearnersLearner Coordination (Mean Scores on Relevant Survey Questions)4.3 score on a scaleStandard Deviation 0.9
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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Credibility (Mean Scores on Relevant Survey Questions)4.5 score on a scaleStandard Deviation 0.7
Interprofessional Education Group - LearnersLearner Credibility (Mean Scores on Relevant Survey Questions)4.9 score on a scaleStandard Deviation 0.3
Just-in-time Education Group - LearnersLearner Credibility (Mean Scores on Relevant Survey Questions)4.7 score on a scaleStandard Deviation 0.5
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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)3.9 score on a scaleStandard Deviation 0.5
Interprofessional Education Group - LearnersLearner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)4.7 score on a scaleStandard Deviation 0.5
Just-in-time Education Group - LearnersLearner Perspectives on Leader Inclusiveness (Mean Scores on Relevant Survey Questions)4.2 score on a scaleStandard Deviation 0.9
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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Psychological Safety (Mean Scores on Relevant Survey Questions)3.9 score on a scaleStandard Deviation 0.7
Interprofessional Education Group - LearnersLearner Psychological Safety (Mean Scores on Relevant Survey Questions)4.6 score on a scaleStandard Deviation 0.5
Just-in-time Education Group - LearnersLearner Psychological Safety (Mean Scores on Relevant Survey Questions)4.7 score on a scaleStandard Deviation 0.5
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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Role Clarity (Mean Scores on Relevant Survey Questions)4.2 score on a scaleStandard Deviation 0.7
Interprofessional Education Group - LearnersLearner Role Clarity (Mean Scores on Relevant Survey Questions)4.9 score on a scaleStandard Deviation 0.3
Just-in-time Education Group - LearnersLearner Role Clarity (Mean Scores on Relevant Survey Questions)4.8 score on a scaleStandard Deviation 0.4
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.

Time frame: Up to 10 weeks

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module because some learner participants did not complete the survey the assessed this outcome.

ArmMeasureValue (MEAN)Dispersion
Traditional Online Continuing Education Group - LearnersLearner Specialization (Mean Scores on Relevant Survey Questions)3.6 score on a scaleStandard Deviation 1.1
Interprofessional Education Group - LearnersLearner Specialization (Mean Scores on Relevant Survey Questions)3.4 score on a scaleStandard Deviation 1.3
Just-in-time Education Group - LearnersLearner Specialization (Mean Scores on Relevant Survey Questions)3.3 score on a scaleStandard Deviation 1.2
Secondary

Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Traditional Online Continuing Education Group - LearnersNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation2 Participants
Interprofessional Education Group - LearnersNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation2 Participants
Just-in-time Education Group - LearnersNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation2 Participants
Interprofessional Education Group - Pre-educationNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation0 Participants
Interprofessional Education - During EducationNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation1 Participants
Interprofessional Education Group - Post-educationNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation1 Participants
Just-in-time Education - Pre-educationNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation4 Participants
Just-in-time Education Group - During EducationNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation1 Participants
Just-in-time Education Group - Post-educationNumber of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026