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

Ventilator Associated Pneumonia Clinical Trial

— BrighT STAR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04987840
• Other study ID #: IRB00263269
• Secondary ID: K24AI141580R01HS
• Status: Enrolling by invitation
• Start date: May 1, 2021
• Est. completion date: June 1, 2027

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: June 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Tracheobronchitis
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
United States	Dell Children's Medical Center	Austin	Texas
United States	Johns Hopkins Children's Center	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cleveland Clinic Children's Hospital	Cleveland	Ohio
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Children's Minnesota Hospital	Minneapolis	Minnesota
United States	Monroe Carell Jr. Children's Hospital	Nashville	Tennessee
United States	Children's Hospital and Medical Center Omaha	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Agency for Healthcare Research and Quality (AHRQ), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Culture Rate	Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month	up to 42 months
Secondary	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
Secondary	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
Secondary	Mortality	Death per hospital total ICU admissions comparing pre and post-intervention periods	up to 42 months
Secondary	Length of ICU stay	Days in ICU; median number of days comparing pre and post-intervention periods	up to 42 months
Secondary	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
Secondary	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
Secondary	ventilator associated infections	Defined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month	up to 42 months
Secondary	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
Secondary	Septic shock	Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions	up to 42 months