A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ventilator Associated Pneumonia, Tracheobronchitis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Respiratory Culture Rate [Time frame: up to 42 months]
Secondary outcome measures (9)
- Broad spectrum antibiotic use for ICU days >2 days [Time frame: up to 42 months]
- New initiations - Broad spectrum antibiotic use for ICU days >2 days [Time frame: up to 42 months]
- Mortality [Time frame: up to 42 months]
- Length of ICU stay [Time frame: up to 42 months]
- ICU readmission [Time frame: up to 42 months]
- Hospital readmission [Time frame: up to 42 months]
- ventilator associated infections [Time frame: up to 42 months]
- Sepsis [Time frame: up to 42 months]
- Septic shock [Time frame: up to 42 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- Johns Hopkins Children's Center — Baltimore
- Boston Children's Hospital — Boston
- Children's Minnesota Hospital — Minneapolis
- Children's Hospital and Medical Center Omaha — Omaha
- Cleveland Clinic Children's Hospital — Cleveland
- Le Bonheur Children's Hospital — Memphis
- Monroe Carell Jr. Children's Hospital — Nashville
- Dell Children's Medical Center — Austin
Identifiers
NCT: NCT04987840 · IRB00263269 · K24AI141580 · R01HS028634