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NCT Number: NCT06187662

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Blood Culture Rates Antibiotic Stewardship Implementation Science

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Mattel Children's Hospital, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Checklist

Behavioral

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.

Targeted messaging

Behavioral

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.

Primary outcomes

  1. Total Blood Culture Rates

    Time frame: Approximately 24 months

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

  2. Acceptability of Intervention Measure (AIM)

    Time frame: 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

  3. Intervention Appropriateness Measure

    Time frame: one 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

  4. Feasibility of Intervention Measure (FIM)

    Time frame: 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 outcomes

  1. Safety Outcomes Post-Intervention

    Time frame: one 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.

Other outcomes

  1. Qualitative Interview Data

    Time frame: one year

    Analyze qualitative interview data from each sites' lead team members to better understand the implementation process for a blood culture diagnostic stewardship program.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: LIBRA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 2, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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