Trial Outcomes & Findings for Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial (NCT NCT05176353)
NCT ID: NCT05176353
Last Updated: 2024-12-03
Results Overview
The number of deaths that occur across the entire study population will be divided by every 1000 days that the total number of patients were hospitalized in study ICUs, receiving mechanical ventilation. Data was collected retrospectively for 5 years prior to the intervention and for 1 year during the intervention period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4892 participants
Primary outcome timeframe
During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).
Results posted on
2024-12-03
Participant Flow
The entire study operated under waiver of consent. There was no "assignment" to the historical control arm. Rather, there was a collection of data retrospectively from persons on ventilators during the five-year period preceding the intervention period.
Participant milestones
| Measure |
Pre-VAP Diagnostic Stewardship
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 2022 - Feb 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Overall Study
STARTED
|
4205
|
687
|
|
Overall Study
COMPLETED
|
4205
|
687
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial
Baseline characteristics by cohort
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
Total
n=4892 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 16.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1705 Participants
n=5 Participants
|
277 Participants
n=7 Participants
|
1982 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2500 Participants
n=5 Participants
|
410 Participants
n=7 Participants
|
2910 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
609 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
712 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3303 Participants
n=5 Participants
|
517 Participants
n=7 Participants
|
3820 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
293 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4205 Participants
n=5 Participants
|
687 Participants
n=7 Participants
|
4892 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).The number of deaths that occur across the entire study population will be divided by every 1000 days that the total number of patients were hospitalized in study ICUs, receiving mechanical ventilation. Data was collected retrospectively for 5 years prior to the intervention and for 1 year during the intervention period.
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days
|
72 Deaths per 1000 patient-days
Interval 62.0 to 75.0
|
73 Deaths per 1000 patient-days
Interval 64.0 to 82.0
|
PRIMARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).The change in ventilator-associated events that occur across the entire study population will be divided by every 1000 days that the total number of patients were hospitalized in study ICUs, receiving mechanical ventilation, as shown by comparing pre-intervention data to post-intervention data. Data was collected retrospectively for 5 years prior to the intervention and for 1 year during the intervention period.
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days
|
15 V-A events per 1000 pt days
Interval 13.0 to 17.0
|
10 V-A events per 1000 pt days
Interval 7.0 to 14.0
|
PRIMARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
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|---|---|---|
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Median Duration of Mechanical Ventilation Per Patient
|
3 Calendar Days
Interval 2.0 to 7.0
|
3 Calendar Days
Interval 2.0 to 7.0
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SECONDARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).Positive respiratory cultures were defined as any respiratory culture growing a bacterial organism, regardless of total colony-forming units/mL
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
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|---|---|---|
|
Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs)
|
127 positive RCs per 1,000 MVPDs
Interval 122.0 to 131.0
|
102 positive RCs per 1,000 MVPDs
Interval 92.0 to 112.0
|
SECONDARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).Rates are shown as total antibiotic days of therapy per 1000 mechanically-ventilated patient days. A "Day of therapy" is defined as a calendar day in which a patient received a systemically-administered antibiotic, regardless of dose. Receipt of multiple, unique antibiotics on a given calendar day were counted cumulatively, that is, if a patient received 3 unique antibiotics that was counted as three days of therapy.
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Total ICU Antibiotic Utilization Rates
|
1361 days of therapy per 1000 patient-days
Interval 1346.0 to 1376.0
|
1335 days of therapy per 1000 patient-days
Interval 1300.0 to 1372.0
|
SECONDARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).Utilization rates are shown as broad-spectrum antibiotic days of therapy per 1000 mechanically-ventilated patient days. Broad-spectrum antibiotics were defined as antibiotics with expected coverage against methicillin-resistant Staphylococcus aureus or Pseudomonas aeruginosa. A "day of therapy" is defined as a calendar day in which a patient received a systemically-administered antibiotic, regardless of dose. Receipt of multiple, unique antibiotics on a given calendar day were counted cumulatively, that is, if a patient received 3 unique antibiotics that was counted as three days of therapy. .
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Broad-spectrum ICU Antibiotic Utilization Rates
|
1199 days of therapy per 1000 patient-days
Interval 1177.0 to 1205.0
|
1149 days of therapy per 1000 patient-days
Interval 1116.0 to 1184.0
|
SECONDARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 Participants
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 Participants
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Number of Respiratory Cultures Ordered Per 1000 Mechanically-ventilated Patient Days
|
334 Cultures ordered per 1000 patient-days
Interval 327.0 to 341.0
|
268 Cultures ordered per 1000 patient-days
Interval 252.0 to 285.0
|
SECONDARY outcome
Timeframe: During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).Population: Some providers ordered more than one culture per patient over the course of their hospital stay.
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=7753 respiratory cultures obtained
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=1049 respiratory cultures obtained
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
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|---|---|---|
|
Percentage of Respiratory Cultures Obtained by Bronchoalveolar Lavage (BAL)
|
53.1 percentage of respiratory cultures
|
56.9 percentage of respiratory cultures
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: This outcome measure only applied to the post-intervention arm. This was an optional test that providers could order, but many providers cancelled the test. Thus few BAL cell count/differentials were sent.
Outcome measures
| Measure |
Pre-VAP Diagnostic Stewardship
n=22 tests
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Percentage of Respiratory Cultures From BAL Samples With Alveolar Neutrophils <50% Following Study Intervention.
|
4.3 Percentage of respiratory cultures
|
—
|
Adverse Events
Pre-VAP Diagnostic Stewardship
Serious events: 278 serious events
Other events: 0 other events
Deaths: 1666 deaths
VAP Diagnostic Stewardship
Serious events: 34 serious events
Other events: 0 other events
Deaths: 284 deaths
Serious adverse events
| Measure |
Pre-VAP Diagnostic Stewardship
n=4205 participants at risk
Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2017- Feb 16, 2022.
|
VAP Diagnostic Stewardship
n=687 participants at risk
Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17, 2022 - Feb 17, 2023.
VAP diagnostic stewardship bundle: Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ventilator associated events
|
6.6%
278/4205 • Number of events 278 • Up to 6 years (including 5 years pre-intervention and 1-year post intervention).
Apart from in-hospital mortality, the only adverse event data collected was ventilator-associated events (VAEs). VAE numbers are complete and accurate, but number of unique persons affected by VAEs was not collected. Given the constraints of the clinicaltrials.gov reporting system, the number of events is replicated in number of persons affected. In fact, the number of persons affected could be equal to or less than that number. No non-serious AE data was collected, thus the denominator is 0.
|
4.9%
34/687 • Number of events 34 • Up to 6 years (including 5 years pre-intervention and 1-year post intervention).
Apart from in-hospital mortality, the only adverse event data collected was ventilator-associated events (VAEs). VAE numbers are complete and accurate, but number of unique persons affected by VAEs was not collected. Given the constraints of the clinicaltrials.gov reporting system, the number of events is replicated in number of persons affected. In fact, the number of persons affected could be equal to or less than that number. No non-serious AE data was collected, thus the denominator is 0.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place