NCT06187662

BrighT STAR LIBRA: Leveraging Implementation Science for Blood Culture Reduction Approaches

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare two strategies that target distinct determinants of blood culture overuse in an exploratory, hybrid, pilot trial in 8 PICUs. It aims to determine if there is any association between specific strategies used to reduce blood culture overuse on unit-wide blood culture rates, patient safety, and concurrently explore aspects of the implementation process (acceptability, feasibility, appropriateness).

Detailed description

Blood cultures are an important test to diagnose bacterial bloodstream infections, but can be ordered reflexively, excessively, and lead to downstream negative patient consequences such as unnecessary antibiotic exposure. Work to date has demonstrated safe and effective reduction in blood culture rates in the pediatric intensive care unit (PICU) setting, but optimal strategies to reduce culture use are currently unknown. The primary study team will initially work with all enrolled sites in an identical fashion, facilitating a core series of steps for implementing a quality improvement blood culture diagnostic stewardship program which is identical to the steps used in the parent study, called BrighT STAR (Testing STewardship to reduce Antibiotic use and Resistance). In addition, the primary study team will randomize sites into two arms, in which different strategies are introduced that each target distinct determinants of blood culture overuse. The primary study team will examine the impact on blood culture rates, as well as evaluate aspects of the implementation process, in all sites pre- vs-post intervention.

Conditions

• Blood Culture Rates
• Antibiotic Stewardship
• Implementation Science

Interventions

Type	Name	Description
BEHAVIORAL	Checklist	This intervention consists of a checklist to guide blood culture decisions, that a clinician in a site randomized to Arm A will be asked to consult and complete prior to ordering or not ordering a blood culture; as the relevant clinical scenario occurs. Meaning, if a clinician in Arm A is faced with a scenario in which it is customary or usual care to consider a blood culture, the clinician will be asked to first review this checklist. The checklist is not a binding or absolute process - the clinician should use both the checklist and typical clinical judgment to decide if the blood culture test is needed or not. The checklist is based on prototypes used in the completed parent study, BrighT STAR and the earlier preliminary studies at Johns Hopkins.
BEHAVIORAL	Targeted Messaging	This intervention consists of targeted messaging and education that the primary study team will create and ask the Arm B sites to deliver to the PICU clinicians, which focuses on the importance of diagnostic stewardship and the current evidence for the benefit/low risk nature of the stewardship program to date.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-01-02
• Last updated: 2025-10-31

Locations

8 sites across 1 country: United States