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

Implementation Science Clinical Trial

— LIBRA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06187662
• Other study ID #: 23-021013
• Secondary ID: 5K23HL151381-03
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Stewardship
• Implementation Science

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	UCLA Mattel Children's Hospital	Los Angeles	California
United States	Norton Children's Hospital	Louisville	Kentucky
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Kravis Children's Hospital	New York	New York
United States	New York-Presbyterian Morgan Stanley Children's Hospital	New York	New York
United States	UCSF Benioff Children's Hospital Mission Bay	San Francisco	California
United States	Nemours / AI DuPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interview Data	Analyze qualitative interview data from each sites' lead team members to better understand the implementation process for a blood culture diagnostic stewardship program.	one year
Primary	Total Blood Culture Rates	Compare differences in clinical outcomes, via total blood culture rates, before and after intervention, as well as between intervention arms	one year
Primary	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
Primary	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
Primary	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	Safety Outcomes Post-Intervention	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.	one year