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

Not Applicable
Active, not recruiting
Conditions
Implementation Science
Blood Culture Rates
Antibiotic Stewardship
Interventions
Behavioral: Checklist
Behavioral: Targeted Messaging
Registration Number
NCT06187662
Lead Sponsor
Children's Hospital of Philadelphia
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
8
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Default BiasChecklistThis 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.
Loss AversionChecklistThis 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. Sites in this arm will also receive a checklist to guide blood culture decisions, that clinicians at sites will be asked to consult and complete prior to ordering or not ordering a blood culture.
Loss AversionTargeted MessagingThis 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. Sites in this arm will also receive a checklist to guide blood culture decisions, that clinicians at sites will be asked to consult and complete prior to ordering or not ordering a blood culture.
Primary Outcome Measures
NameTimeMethod
Total Blood Culture Ratesone year

Compare differences in clinical outcomes, via total blood culture rates, before and after intervention, as well as between intervention arms

Intervention Appropriateness Measureone year

Compare differences in implementation outcomes, via Implementation Appropriateness Measure (IAM) surveys, before and after intervention, as well as between intervention arms. The IAM survey consists of a 4-item measure using a 5-point Likert scale, where 1=Completely disagree and 5=Completely agree

Acceptability of Intervention Measure (AIM)one year

Compare differences in implementation outcomes, via AIM surveys, before and after intervention, as well as between intervention arms. The AIM survey consists of a 4-item measure using a 5-point Likert scale, where 1=Completely disagree and 5=Completely agree

Feasibility of Intervention Measure (FIM)one year

Compare differences in implementation outcomes, via FIM surveys, before and after intervention, as well as between intervention arms. The FIM survey consists of a 4-item measure using a 5-point Likert scale, where 1=Completely disagree and 5=Completely agree

Secondary Outcome Measures
NameTimeMethod
Safety Outcomes Post-Interventionone year

Monitor safety outcomes of the blood culture diagnostic stewardship program in all sites, defined as episodes of delay in diagnosis of bacteremia in enrolled sites post-implementation of the pilot study; using chart review and a standardized safety event review form that is identical to the completed parent study, BrighT STAR.

Trial Locations

Locations (8)

UCLA Mattel Children's Hospital

🇺🇸

Los Angeles, California, United States

UCSF Benioff Children's Hospital Mission Bay

🇺🇸

San Francisco, California, United States

Riley Hospital for Children

🇺🇸

Indianapolis, Indiana, United States

Children's Hospital of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Nemours / AI DuPont Hospital for Children

🇺🇸

Wilmington, Delaware, United States

Kravis Children's Hospital

🇺🇸

New York, New York, United States

Norton Children's Hospital

🇺🇸

Louisville, Kentucky, United States

New York-Presbyterian Morgan Stanley Children's Hospital

🇺🇸

New York, New York, United States

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