Clinical trial NCT06187662: BrighT STAR LIBRA: Leveraging Implementation Science for Blood Culture Reduction Approaches
Official title: BrighT STAR LIBRA: Leveraging Implementation Science for Blood Culture Reduction Approaches
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Culture Rates
Antibiotic Stewardship
Implementation Science
Keywords: blood culture
antibiotic stewardship
implementation
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Johns Hopkins University
First posted: 2024-01-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study sites will be randomized into two arms, in which different strategies are introduced that each target distinct determinants of blood culture overuse
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Males or females over 18 years old
* PICU clinicians with direct patient care roles

Exclusion Criteria:

* Non-English speaking
* PICU clinicians who report to the investigator

Primary outcomes:
measure: Total Blood Culture Rates
timeFrame: one year
measure: Acceptability of Intervention Measure (AIM)
timeFrame: one year
measure: Intervention Appropriateness Measure
timeFrame: one year
measure: Feasibility of Intervention Measure (FIM)
timeFrame: one year
Secondary outcomes:
measure: Safety Outcomes Post-Intervention
timeFrame: one year
Other outcomes:
measure: Qualitative Interview Data
timeFrame: one year
Locations:
city: Los Angeles
country: United States
facility: UCLA Mattel Children's Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital Mission Bay
state: California
city: Wilmington
country: United States
facility: Nemours / AI DuPont Hospital for Children
state: Delaware
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: New York
country: United States
facility: Kravis Children's Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian Morgan Stanley Children's Hospital
state: New York
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Charlotte Woods-Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: