Blood Culture Reduction Approaches for Sepsis

(LIBRA Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce unnecessary blood tests in pediatric intensive care units (PICUs). It tests two approaches: using a checklist to guide decisions and providing targeted messages to help doctors make informed choices. The goal is to determine if these methods can lower blood test rates without compromising patient safety. Clinicians in PICUs who deliver direct patient care and speak English may be suitable for this study. As an unphased trial, this study allows clinicians to contribute to improving patient care practices in PICUs.

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 prior data suggests that these strategies are safe for reducing blood culture overuse?

Past studies have shown that using tools like checklists and specific messages is safe. Checklists for treating sepsis proved to be safe and practical, although some studies couldn't fully confirm their effectiveness. Other research demonstrated that checklists reduced unnecessary blood tests by 25%.

For targeted messaging, studies found that these messages helped lower the number of blood tests ordered without causing harm. Educating doctors to order only necessary tests can improve patient care without added risk.

Both checklists and targeted messaging are generally well-received. They help hospital staff make better decisions without introducing new risks to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these trial interventions for sepsis because they focus on improving decision-making for blood cultures, a key diagnostic tool. The "Default Bias" arm uses a checklist to guide clinicians in deciding whether to order a blood culture, potentially reducing unnecessary tests and improving patient care. The "Loss Aversion" arm combines this checklist with targeted messaging and education, emphasizing the benefits and low risks of diagnostic stewardship. These approaches are unique because they aim to enhance clinical judgment and reduce overtesting, unlike current practices that often rely heavily on routine testing without such structured guidance.

What evidence suggests that this trial's strategies could be effective in reducing blood culture overuse in sepsis?

In this trial, participants will follow different approaches to improve blood culture decisions in sepsis care. One group will use a checklist to guide clinicians on when to take blood samples. Research shows this can make the process quicker and more efficient. Specifically, one study found that such tools ensured prompt blood sample collection when an infection was suspected. Another group will focus on targeted messaging and education, including educational messages to enhance diagnostic stewardship. A review of several studies found that alert systems for sepsis, often incorporating educational messages, helped doctors adhere to guidelines better and improved patient outcomes. These educational messages and reminders have made collecting blood samples faster and safer. ^{4 6 7 8 9}

Who Is on the Research Team?

Charlotte Woods-Hill, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9471721/

Clinical decision support improves blood culture collection ... Our study demonstrates that a simple CDS intervention can improve timely blood culture collections when the concern for infection is high enough ...

2. cdc.gov cdc.gov/sepsis/hcp/core-elements/index.html

Hospital Sepsis Program Core Elements Sepsis outcomes metrics, such as mortality, ICU admission, and length of hospitalization, are important to understanding the outcomes of hospital sepsis ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1432433/full

Effectiveness of multidisciplinary interventions to improve ... A multidisciplinary collaborative model proves effective in improving blood culture efficiency and optimizing antimicrobial usage.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK263078/

Data extraction forms for clinical effectiveness studies Data are from the subset of checklists that reported insertion site (10850 of 11575 checklists; 93.7%).

5. cureus.com cureus.com/articles/225424-effectiveness-of-multimodal-intervention-to-improve-blood-culture-collection-in-a-tertiary-care-hospital

Effectiveness of Multimodal Intervention to Improve Blood ... Results. On analysis, the blood culture contamination rate in the pre-interventional phase dropped drastically from 6.16% to 3.03% in the post- ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555517/

Sepsis Recognition - Making Healthcare Safer III - NCBI - NIH The outcomes studied were mortality, ICU admissions rate, and ICU LOS. Attributing improvement in these outcomes to sepsis screening tools is difficult, however ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8486643/

Surviving sepsis campaign: international guidelines for ... The results demonstrated that the intervention was feasible and safe, but the study was underpowered and therefore inconclusive regarding its clinical ...

8. cdc.gov cdc.gov/mmwr/volumes/72/wr/mm7234a2.htm

Sepsis Program Activities in Acute Care Hospitals In 2022, 73% of hospitals reported having a sepsis program, ranging from 53% among hospitals with 0–25 beds to 95% among hospitals with >500 beds.

9. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2592303

Association of a Clinical Practice Guideline With Blood ... After the intervention, there was an immediate 25.0% reduction in the rate of cultures per 100 patient-days (95% CI, 4.2%-39.7%; P = .02) and a ...