Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05989269
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-08-03
Brief Title:
Diagnostic Stewardship for Ventilator Associated Pneumonia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Diagnostic Stewardship for Ventilator Associated Pneumonia A Pragmatic Cluster-randomized Crossover Trial of a Hybrid Order-review and Laboratory Reporting Intervention
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pragmatic cluster-randomized crossover trial is to test if less unnecessary antibiotics are prescribed when the lab reports respiratory culture test results in a specific way for patients who have respiratory cultures obtained but do not meet clinical criteria for ventilator associated pneumonia VAP The main question it aims to answer is Does a modified culture reporting intervention reduce unnecessary antibiotics for ventilated patients in the intensive care unit ICU Researchers will compare antibiotic use outcomes between eligible patients whose test results are communicated using the modified reporting and those with standard reporting of results
Detailed Description:
The specific aims of this project are
Specific Aim 1 In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers evaluate the impact of a VAP diagnostic stewardship intervention on antibiotic use VAP diagnoses and adverse events
Hypothesis A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs control periods across all sites without a change in adverse events is expected
Specific Aim 2 Evaluate overall impact of intervention including clinical and antibiotic outcomes using the Desirability of Outcome Ranking DOOR Response Adjusted for Duration of Antibiotic Risk RADAR methodology
Hypothesis A change in overall patient outcomes better DOOR ranking accounting for duration of antibiotic use in the intervention vs control period is expected
Specific Aim 1 In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers evaluate the impact of a VAP diagnostic stewardship intervention on antibiotic use VAP diagnoses and adverse events
Hypothesis A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs control periods across all sites without a change in adverse events is expected
Specific Aim 2 Evaluate overall impact of intervention including clinical and antibiotic outcomes using the Desirability of Outcome Ranking DOOR Response Adjusted for Duration of Antibiotic Risk RADAR methodology
Hypothesis A change in overall patient outcomes better DOOR ranking accounting for duration of antibiotic use in the intervention vs control period is expected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None