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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL143507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional online continuing education | Active Comparator |
| |
| Interprofessional education | Active Comparator |
| |
| Just-in-time education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional online continuing education | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ICU Team Members (Learners) Who Received Education | This implementation outcome measuring reach only applies to learner participants. | Up to 1 month |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Learner Role Clarity (Mean Scores on Relevant Survey Questions) |
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Two study populations will be included.
Learners (population 1) will include:
Frontline care providers will be excluded if they:
Patients (population 2) will include:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy D Girard, MD, MSCI | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21765357 | Background | 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. | |
| 19682735 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Interprofessional Education - During Education | Patients admitted during the one-month education period to the ICU that participated in interprofessional education. |
| FG005 | Interprofessional Education Group - Post-education | Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | Traditional Online Continuing Education Group - Learners | Learners who participated in traditional online continuing education |
| FG010 | Interprofessional Education Group - Learners | Learners who participated in interprofessional education |
| FG011 | Just-in-time Education Group - Learners | Learners who participated in just-in-time education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Traditional Online Continuing Education Group - During Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected and analyzed only for patient participants. The characteristics of learner participants were not recorded. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of ICU Team Members (Learners) Who Received Education | This implementation outcome measuring reach only applies to learner participants. | Posted | Count of Participants | Participants | Up to 1 month |
|
In-hospital, up to 60 days
In-hospital adverse events only apply to patient groups. All-cause mortality, serious adverse events, and other (not including serious) adverse events were not monitored in the learner groups because participation involved minimal risk for learners.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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By design, this was a non-randomized pilot trial intended to assess the feasibility, acceptability, and preliminary impact of three strategies designed to speed implementation of post-extubation noninvasive ventilation among high-risk patients recovering from acute respiratory failure. The effects of the educational interventions on patient outcomes cannot be reliably determined using data from this trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy D Girard, MD, MSCI | University of Pittsburgh School of Medicine | (412) 383-0582 | timothy.girard@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2018 | Jul 8, 2021 | Prot_SAP_000.pdf |
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|
| Interprofessional education | Behavioral | 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 | Behavioral | "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 |
|
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) | 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) | 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) | 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) | 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) | 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 |
| 27818331 | Background | 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. |
| 28860265 | Background | 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. |
Patients admitted during the one-month education period to the ICU that participated in traditional online continuing education. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Interprofessional Education - During Education | Patients admitted during the one-month education period to the ICU that participated in interprofessional education. |
| BG005 | Interprofessional Education Group - Post-education | Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | Traditional Online Continuing Education Group - Learners | Learners who participated in traditional online continuing education |
| BG010 | Interprofessional Education Group - Learners | Learners who participated in interprofessional education |
| BG011 | Just-in-time Education Group - Learners | Learners who participated in just-in-time education |
| BG012 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Baseline characteristics were collected and analyzed only for patient participants. The characteristics of learner participants were not recorded. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline characteristics were collected and analyzed only for patient participants. The characteristics of learner participants were not recorded. | Count of Participants | Participants |
|
| Sequential Organ Failure Assessment (SOFA) Score | The Sequential Organ Failure Assessment (SOFA) score is a validated tool that quantifies the number and severity of failed organs. Higher scores indicate worse organ failure. Minimum = 0; maximum = 24. | The Sequential Organ Failure Assessment (SOFA) score does not apply to learner participants. | Median | Inter-Quartile Range | units on a scale |
|
Learners who participated in just-in-time education |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
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| Secondary | Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation | This implementation outcome only applies to patient participants. | Posted | Count of Participants | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
|
|
|
| 44 |
| 116 |
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | 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. | 10 | 28 | 0 | 28 | 0 | 28 |
| EG002 | 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. | 61 | 146 | 0 | 146 | 0 | 146 |
| EG003 | 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. | 37 | 188 | 0 | 188 | 0 | 188 |
| EG004 | Interprofessional Education - During Education | Patients admitted during the one-month education period to the ICU that participated in interprofessional education. | 8 | 24 | 0 | 24 | 0 | 24 |
| EG005 | Interprofessional Education Group - Post-education | Patients admitted during the 6 months after the education period to the ICU that participated in interprofessional education. | 58 | 183 | 0 | 183 | 0 | 183 |
| EG006 | 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. | 130 | 275 | 0 | 275 | 0 | 275 |
| EG007 | 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. | 5 | 27 | 0 | 27 | 0 | 27 |
| EG008 | 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. | 57 | 276 | 0 | 276 | 0 | 276 |
| EG009 | Traditional Online Continuing Education Group - Learners | Learners who participated in traditional online continuing education | 0 | 0 | 0 | 0 | 0 | 0 |
| EG010 | Interprofessional Education Group - Learners | Learners who participated in interprofessional education | 0 | 0 | 0 | 0 | 0 | 0 |
| EG011 | Just-in-time Education Group - Learners | Learners who participated in just-in-time education | 0 | 0 | 0 | 0 | 0 | 0 |
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| Male |
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| Black |
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| Other |
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