Blood Culture Reduction Approaches for Sepsis

(LIBRA Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Non-English speaking, Reports to investigator

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Checklist, Targeted Messaging for reducing blood cultures in sepsis?

Research shows that using a dedicated sepsis response team and providing regular feedback to clinicians can improve care processes and reduce mortality in sepsis patients. Additionally, effective screening tools that combine different criteria can significantly improve the recognition of sepsis, which may support the effectiveness of targeted messaging and checklists in managing sepsis. ^{1 2 3 4 5}

Is the blood culture reduction approach for sepsis safe for humans?

The studies reviewed did not report any negative safety signals related to the blood culture reduction approach, suggesting it is generally safe for use in humans. ^{6 7 8 9 10}

Research Team

Charlotte Woods-Hill, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for male or female clinicians over 18 years old who work in Pediatric Intensive Care Units (PICUs) and have direct patient care roles. It's not open to those who don't speak English or PICU clinicians reporting directly to the investigator.

Inclusion Criteria

I am over 18 years old.

PICU clinicians with direct patient care roles

Exclusion Criteria

PICU clinicians who report to the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a quality improvement blood culture diagnostic stewardship program across all sites, followed by randomization into two arms with different strategies.

12 months

Regular site visits and virtual meetings

Evaluation

Evaluation of blood culture rates and implementation outcomes using surveys and qualitative interviews.

12 months

Follow-up

Participants are monitored for safety outcomes and effectiveness of the intervention post-implementation.

4 weeks

Treatment Details

Interventions

• Checklist
• Targeted Messaging

Trial Overview The study compares two strategies: a checklist and targeted messaging, aimed at reducing unnecessary blood culture tests in PICUs. It explores how these strategies affect test rates, patient safety, and evaluates their acceptability and feasibility.

Participant Groups

Group I: Loss Aversion Experimental Treatment 2 Interventions

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.

Group II: Default Bias Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

A quality improvement initiative for sepsis management, including an electronic screening tool and a First-Dose STAT Antibiotic policy, led to significant reductions in ICU length of stay (from 5.85 to 4.21 days) and overall treatment costs (from $14,378 to $12,311) for patients with sepsis.

While there were nonsignificant decreases in overall length of stay and in-hospital mortality, the initiative effectively improved early recognition and treatment of sepsis, as indicated by a decrease in the percentage of patients with the highest disease-severity coding from 7.9% to 0%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and economic impact of a quality improvement initiative to enhance early recognition and treatment of sepsis. Judd, WR., Stephens, DM., Kennedy, CA.[2018]

A study analyzing 55 sepsis cases in Poland found that the most common medical errors stemmed from a lack of knowledge regarding recognition, diagnosis, and treatment of sepsis, leading to adverse events.

Key risk factors for these adverse events included communication errors, insufficient medical staff, and a tendency to simplify serious symptoms, highlighting the need for improved training and management protocols for healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sepsis in Poland: why do we die? Rorat, M., Jurek, T.[2023]

A multi-incident analysis of 28 serious adverse events related to paediatric sepsis in Queensland revealed a high mortality rate, particularly in children under 4 years old, highlighting the vulnerability of this age group.

Key contributing factors to these adverse events included difficulties in recognizing deteriorating patients, diagnostic delays, and communication issues within healthcare systems, suggesting areas for improvement to enhance early identification and treatment of sepsis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-incident analysis of reviews of serious adverse clinical events in children with serious bacterial infection and/or sepsis in Queensland, Australia between 2012 and 2017. Coulthard, MG., Osborne, JM., McCaffery, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sepsis Screening: Combining Early Warning Scores and SIRS Criteria. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Septic shock: a multidisciplinary response team and weekly feedback to clinicians improve the process of care and mortality. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Multimodal Sepsis Quality-Improvement Initiative Including 24/7 Screening and a Dedicated Sepsis Response Team-Reduced Readmissions and Mortality. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical and economic impact of a quality improvement initiative to enhance early recognition and treatment of sepsis. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Sepsis in Poland: why do we die? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Implementation of a diagnostic stewardship intervention to improve blood-culture utilization in 2 surgical ICUs: Time for a blood-culture change. [2023]

8. Poland pubmed.ncbi.nlm.nih.gov

Point-of-Care Verification of Blood Culture Volume in Neonates: A Feasibility Trial. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a model to improve collection of blood cultures in patients with sepsis in the emergency room. [2018]

10. Australia pubmed.ncbi.nlm.nih.gov

Multi-incident analysis of reviews of serious adverse clinical events in children with serious bacterial infection and/or sepsis in Queensland, Australia between 2012 and 2017. [2022]