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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04987840
Acronym
BrighT STAR
Enrollment
15
Registered
2021-08-03
Start date
2021-05-01
Completion date
2027-06-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheobronchitis, Ventilator Associated Pneumonia

Keywords

Diagnostic Stewardship, Pediatric, Respiratory Culture Test

Brief summary

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.

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.

Interventions

None listed

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Culture Rateup to 42 monthsRate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month

Secondary

MeasureTime frameDescription
Broad spectrum antibiotic use for ICU days >2 daysup to 42 monthsOver all use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter
New initiations - Broad spectrum antibiotic use for ICU days >2 daysup to 42 monthsAntibiotic days per 1,000 patient-days per month (antibiotic days starting on day 3 of ICU admission)
Mortalityup to 42 monthsDeath per hospital total ICU admissions comparing pre and post-intervention periods
Length of ICU stayup to 42 monthsDays in ICU; median number of days comparing pre and post-intervention periods
ICU readmissionup to 42 monthsReadmission 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
Hospital readmissionup to 42 monthsReadmission 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
ventilator associated infectionsup to 42 monthsDefined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month
Sepsisup to 42 monthsdefined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions
Septic shockup to 42 monthsDefined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAaron Milstone, MD, MHS

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026