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

NCT06187662 | Active Not Recruiting

• 2 other identifiers: 23-0210135K23HL151381-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 8

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).

Conditions

Blood Culture Rates; Antibiotic Stewardship; Implementation Science

Keywords

blood culture; antibiotic stewardship; implementation

Outcome Measures

Primary Outcomes (4)

• Total Blood Culture Rates

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

  Approximately 24 months

• Acceptability of Intervention Measure (AIM)

  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

  one year

• Intervention Appropriateness Measure

  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

  one year

• Feasibility of Intervention Measure (FIM)

  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

  one year

Secondary Outcomes (1)

• Safety Outcomes Post-Intervention

  one year

Other Outcomes (1)

• Qualitative Interview Data

  one year

Study Arms (2)

Default Bias

EXPERIMENTAL

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.

Behavioral: Checklist

Loss Aversion

EXPERIMENTAL

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. 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.

Behavioral: Checklist; Behavioral: Targeted Messaging

Interventions

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.

Default Bias; Loss Aversion

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.

Loss Aversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Johns Hopkins University: collaborator

Study Sites (8)

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

Location

UCSF Benioff Children's Hospital Mission Bay

San Francisco, California, 94158, United States

Location

Nemours / AI DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Kravis Children's Hospital

New York, New York, 10019, United States

Location

New York-Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Interventions

Checklist

Intervention Hierarchy (Ancestors)

Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Charlotte Woods-Hill, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The primary study team will know which arm the participating site PICUs will be in, but the local study team and care teams will be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study sites will be randomized into two arms, in which different strategies are introduced that each target distinct determinants of blood culture overuse

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)