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

Johns Hopkins University logo

Johns Hopkins University

Status

Invitation-only

Conditions

Ventilator Associated Pneumonia
Tracheobronchitis

Study type

Observational

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT04987840
R01HS028634 (U.S. AHRQ Grant/Contract)
IRB00263269
K24AI141580 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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