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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventilator Associated Pneumonia, Tracheobronchitis

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Stewardship, Pediatric, Respiratory Culture Test