Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial

NCT05176353 | Completed Results

• 2 other identifiers: HUM002031625UL1TR002240-05
• Study Type: interventional
• Target: 4,892
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective pilot/feasibility trial of a bundled diagnostic stewardship intervention at the level of the microbiologic testing pathway in ventilator-associated pneumonia (VAP). The study utilized a pre/post design and was initially registered as a single-arm trial because the study intervention could only be applied prospectively to a single group (all patients hospitalized in study ICUs requiring ventilation during the trial intervention period). The study objectives are to safely and effectively reduce antibiotic overuse and its attendant hazards (adverse drug events, Clostridioides difficile diarrhea and generation of multidrug-resistant organisms) among mechanically-ventilated patients. Participating ICUs will have the following three modifications made in their respiratory culture workflows for mechanically-ventilated patients: 1) providers will be required to select a valid indication for respiratory culture performance (worsening ventilator requirements, purulent sputum production, and/or new radiographic infiltrate on chest imaging); 2) respiratory cultures will be preferentially obtained via bronchoscopic or nonbronchoscopic BAL (by respiratory therapists) rather than via endotracheal aspiration; and 3) BAL samples will be sent for cell count and differentials, and respiratory culture results will not be released for samples with \<50% neutrophils. The study will carefully monitor adherence to study interventions, ICU-specific antibiotic utilization rates, and important safety metrics including rates of mortality, ventilator-dependence and ventilator-associated events. The trial hypotheses are:

• Implementation of a VAP diagnostic stewardship bundle will be successfully implemented without significant increases in mortality or ventilator-associated events.
• Implementation of a VAP diagnostic stewardship bundle will be associated with a reduction in ICU-specific antibiotic utilization rates

Conditions

VAP - Ventilator Associated Pneumonia

Keywords

Antimicrobial stewardship; Ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (3)

• Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days

  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.

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

• Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days

  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.

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

• Median Duration of Mechanical Ventilation Per Patient

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

Secondary Outcomes (6)

• Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs)

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

• Total ICU Antibiotic Utilization Rates

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

• Broad-spectrum ICU Antibiotic Utilization Rates

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

• Number of Respiratory Cultures Ordered Per 1000 Mechanically-ventilated Patient Days

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

• Percentage of Respiratory Cultures Obtained by Bronchoalveolar Lavage (BAL)

  During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year).

Study Arms (2)

VAP diagnostic stewardship

EXPERIMENTAL

Intervention group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17 2022 - Feb 17 2023.

Other: VAP diagnostic stewardship bundle

Pre-VAP diagnostic stewardship

NO INTERVENTION

Pre-intervention historical control group - all patients hospitalized in study ICUs who were mechanically ventilated Feb 17 2017-Feb 16 2022. While these patients were all mechanically ventilated, their treatment took place prior to the beginning of the study, under what standard or standards of care existed at the time. They received no treatment during the course of the study. No interventions could be assigned because their treatment was performed prior to study start date.

Interventions

VAP diagnostic stewardship bundle OTHER

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.

VAP diagnostic stewardship

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients hospitalized within the Michigan Medicine Cardiac Care Unit (CCU, 7D) and the Michigan Medicine Critical Care Medicine Unit (CCMU, 6D)

You may not qualify if:

• international normalized ratio (INR)\>2,
• platelet count \<50,
• gross blood in endotracheal secretions,
• ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2), ratio (P/F ratio)\<80,
• major lung surgery within prior 30 days.
• healthcare providers working in units (CCU and CCMU) as part of routine clinical care.
• healthcare providers that are not as part of routine care in CCU and CCMU

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48170, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Ventilator-Associated Event numbers are complete and accurate, but number of unique persons affected by ventilator-associated events 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.

Results Point of Contact

• Title: Owen Albin, MD
• Organization: University of Michigan

oalbin@med.umich.edu

734.232.1871

Study Officials

• Owen Albin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of this pilot trial the study will obtain an exemption from informed consent.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: Implementation of a VAP diagnostic stewardship bundled intervention targeting ordering, collection and reporting results of respiratory cultures among mechanically-ventilated patients. Interventions will be implemented through a custom order set within the institutional electronic medical record in 2-month sequential intervals. Safety, ICU-specific antibiotic utilization rates and adherence to study interventions will be monitored.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 4, 2022
• Study Start: February 11, 2022
• Primary Completion: February 12, 2023
• Study Completion: March 14, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)