Clinical trial NCT04987840: A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
Official title: A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventilator Associated Pneumonia
Tracheobronchitis
Keywords: Diagnostic Stewardship
Pediatric
Respiratory Culture Test
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-08-03
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patient populations from units that develop and implement a quality improvement program to reduce respiratory culture use

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.

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

Primary outcomes:
measure: Respiratory Culture Rate
timeFrame: up to 42 months
Secondary outcomes:
measure: Broad spectrum antibiotic use for ICU days >2 days
timeFrame: up to 42 months
measure: New initiations - Broad spectrum antibiotic use for ICU days >2 days
timeFrame: up to 42 months
measure: Mortality
timeFrame: up to 42 months
measure: Length of ICU stay
timeFrame: up to 42 months
measure: ICU readmission
timeFrame: up to 42 months
measure: Hospital readmission
timeFrame: up to 42 months
measure: ventilator associated infections
timeFrame: up to 42 months
measure: Sepsis
timeFrame: up to 42 months
measure: Septic shock
timeFrame: up to 42 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Children's Minnesota Hospital
state: Minnesota
city: Omaha
country: United States
facility: Children's Hospital and Medical Center Omaha
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Clinic Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Aaron Milstone, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: