A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children (BrighT STAR)

The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ventilator Associated Pneumonia; Tracheobronchitis

Detailed Description

The Bright STAR Collaborative, or Testing STewardship to reduce Antibiotic Resistance Collaborative, is a prospective multicenter quality improvement (QI) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.

Greater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).

Specific Aim 1: Evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use.

Specific Aim 2: To determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock.

Variables: total respiratory culture rates, culture results, ICU length of stay, mortality rates, hospital and ICU readmission, cause of death, ventilator-associated infection/ventilator-associated condition rate, sepsis, septic shock.

Analysis: The analytic approach equates to estimating and comparing the respiratory culture incidence during the "baseline/pre-implementation" and "post-implementation" periods, using a generalized linear mixed model (GLMM) assuming a Poisson distribution for the monthly number of respiratory cultures with the monthly number of ventilator days as an offset. Similar analyses will be performed for secondary outcomes.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Children's Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Minnesota Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital and Medical Center Omaha
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Children's Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICU patient populations from units that develop and implement a quality improvement program to reduce respiratory culture use

Description

Inclusion Criteria:

• Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

Exclusion Criteria:

• Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Culture Rate	Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month	up to 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Broad spectrum antibiotic use for ICU days >2 days	Over all use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter	up to 42 months
New initiations - Broad spectrum antibiotic use for ICU days >2 days	Antibiotic days per 1,000 patient-days per month (antibiotic days starting on day 3 of ICU admission)	up to 42 months
Mortality	Death per hospital total ICU admissions comparing pre and post-intervention periods	up to 42 months
Length of ICU stay	Days in ICU; median number of days comparing pre and post-intervention periods	up to 42 months
ICU readmission	Readmission to the ICU within 7 days of discharge. The coordinating center will measure the change in rate of readmission per total ICU admissions comparing pre and post-intervention periods	up to 42 months
Hospital readmission	Readmission to hospital within 7 days of discharge. The coordinating center will measure the change in rate of hospital readmission comparing pre and post-intervention periods	up to 42 months
ventilator associated infections	Defined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month	up to 42 months
Sepsis	defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions	up to 42 months
Septic shock	Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions	up to 42 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Aaron Milstone, MD, MHS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Diagnostic Stewardship; Respiratory Culture Test
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: IRB00263269; K24AI141580 (U.S. NIH Grant/Contract); R01HS028634 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No