Diagnostic Stewardship for Ventilator Associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2025-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a pragmatic cluster-randomized crossover trial in 6 adult ICUs (1 medical and 1 surgical ICU each at 3 hospitals). ICUs (clusters) will be randomized at the hospital-level (1:1) to a sequence of intervention (6 months) followed by control (6 months), or vice-versa. The study population is ventilated patients with respiratory culture orders but not meeting clinical pneumonia criteria, and organism(s) growing in respiratory culture. A research physician will evaluate likelihood of pneumonia using a standard clinical algorithm, within 24 hours of the order Mon-Fri. If pneumonia criteria are not met AND there is growth of organism(s) (except normal respiratory flora), during the intervention period, the culture report will be modified to reflect the likelihood of asymptomatic colonization instead of reporting bacterial identification. Clinicians may call the lab for identification and susceptibilities if necessary. During the control period, no modification to reporting will occur.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Ordering care providers will not be aware if the test results are eligible for modified reporting or not.

Study Groups

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Control Period

Laboratory reporting of respiratory cultures will continue per regular or routine laboratory protocols (standard reporting).

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

The lab will publish a modified report for respiratory cultures which do not meet clinical criteria for pneumonia and have growth of organisms (other than normal respiratory flora). The modified report will include the likelihood of colonization instead of reporting bacterial identification.

Group Type OTHER

Modified lab reporting

Intervention Type OTHER

If appropriateness of culturing i.e., clinical criteria for pneumonia testing does not meet the algorithm AND there is growth of one or more organism(s) that are not considered normal upper respiratory flora, during the intervention period, the result will be modified to reflect the likelihood of asymptomatic colonization.

Interventions

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Modified lab reporting

If appropriateness of culturing i.e., clinical criteria for pneumonia testing does not meet the algorithm AND there is growth of one or more organism(s) that are not considered normal upper respiratory flora, during the intervention period, the result will be modified to reflect the likelihood of asymptomatic colonization.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient located on ICU unit included in the study
* Patient is mechanically ventilated
* Patient had respiratory culture sent \>48 hours after admission
* Patient age ≥ 18 years

Exclusion Criteria

* Extra corporeal membrane oxygenation (ECMO) at time of respiratory culture
* Heart or lung transplant
* Culture rejected by lab per standard lab protocol
* Prisoners
* Severe immunosuppression as defined by:
* \<6 months from solid organ transplant (SOT) OR \<6 months from treatment for acute rejection following SOT
* Active treatment for lymphoreticular malignancies
* Neutropenic \< 1000
* Receiving lymphodepleting chemotherapy
* Allogeneic stem cell transplants \<6 months
* Autologous stem cell transplants or chimeric antigen receptor T-cell (CAR-T) therapy \<6 months out
* Allogeneic stem cell transplant with graft vs host disease (GVHD) or receiving 2 or more immunosuppressants
* Advanced or untreated human immunodeficiency virus (HIV) infection with CD4 \< 200
* Receiving biologics within 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No