Clinical trial NCT05989269: Diagnostic Stewardship for Ventilator Associated Pneumonia
Official title: Diagnostic Stewardship for Ventilator Associated Pneumonia: A Pragmatic Cluster-randomized Crossover Trial of a Hybrid Order-review and Laboratory Reporting Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventilator Associated Pneumonia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: George Washington University
name: Baylor College of Medicine
name: Virginia Commonwealth University
First posted: 2023-08-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of unnecessary antibiotic therapy
timeFrame: Respiratory culture collection date through day 28 or patient discharge
Secondary outcomes:
measure: Antibiotic consumption
timeFrame: Measured over the 6 month control period and the 6 month intervention period
measure: Frequency of clinical diagnosis of VAP and tracheobronchitis
timeFrame: Measured within the 7 days after the index respiratory culture
measure: Antibiotic use outcome sensitivity analysis
timeFrame: Measured within the 7 days after the index respiratory culture
measure: Number of Ventilator-free days
timeFrame: Measured within the 28 days after the index respiratory culture
measure: Frequency of provider requests for complete reports
timeFrame: Measured during the 6 month intervention period
measure: Incidence of Adverse Events
timeFrame: Measured within the 7 days after the index respiratory culture
Other outcomes:
measure: Desirability of Outcome Ranking (DOOR)/Response Adjusted for Duration of Antibiotic Risk (RADAR)
timeFrame: Measured within the 28 days after the index respiratory culture
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Maryland, Baltimore
name: Surbhi Leekha, MD
role: PRINCIPAL_INVESTIGATOR
References: