A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
- Conditions
- TracheobronchitisVentilator Associated Pneumonia
- Registration Number
- NCT04987840
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 15
- Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs
- Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiratory Culture Rate up to 42 months Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month
- Secondary Outcome Measures
Name Time Method Length of ICU stay up to 42 months Days in ICU; median number of days comparing pre and post-intervention periods
Hospital readmission up to 42 months 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
ventilator associated infections up to 42 months Defined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month
Septic shock up to 42 months Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions
Broad spectrum antibiotic use for ICU days >2 days up to 42 months Over all use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter
Sepsis up to 42 months defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions
ICU readmission up to 42 months 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
New initiations - Broad spectrum antibiotic use for ICU days >2 days up to 42 months Antibiotic days per 1,000 patient-days per month (antibiotic days starting on day 3 of ICU admission)
Mortality up to 42 months Death per hospital total ICU admissions comparing pre and post-intervention periods
Trial Locations
- Locations (8)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Children's Center
🇺🇸Baltimore, Maryland, United States
Cleveland Clinic Children's Hospital
🇺🇸Cleveland, Ohio, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital and Medical Center Omaha
🇺🇸Omaha, Nebraska, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Children's Minnesota Hospital
🇺🇸Minneapolis, Minnesota, United States
Monroe Carell Jr. Children's Hospital
🇺🇸Nashville, Tennessee, United States