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

NCT ID: NCT04987840

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2027-06-01

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.

Conditions

Ventilator Associated Pneumonia; Tracheobronchitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Milstone, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Minnesota Hospital

Minneapolis, Minnesota, United States

Children's Hospital and Medical Center Omaha

Omaha, Nebraska, United States

Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Monroe Carell Jr. Children's Hospital

Nashville, Tennessee, United States

Dell Children's Medical Center

Austin, Texas, United States

Countries

United States

Other Identifiers

K24AI141580

Identifier Type: NIH

Identifier Source: secondary_id

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R01HS028634

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

IRB00263269

Identifier Type: -

Identifier Source: org_study_id