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Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Treatment in Pediatric Septic Shock

NCT05065333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1345

Last updated 2023-04-19

No results posted yet for this study

Summary

This study is a prospective, stepped-wedge implementation trial to test the effects of implementing a Clinical Decision Support (CDS) tool for prediction of septic shock in four Emergency Departments within a pediatric healthcare network. The primary outcome will be the proportion of sepsis patients who receive guideline-concordant septic shock care after implementation of the CDS, and the secondary outcome will be time-to-antibiotic after sepsis recognition.

Conditions

  • Sepsis
  • Septic Shock
  • Emergencies

Interventions

OTHER

Septic Shock Clinical Decision Support

The intervention will be activating a septic shock clinical decision support tool (CDS) in the Electronic Health Record at the site, making it available to trigger and alert Emergency Department providers during clinical care. Patients will be identified when providers suspect sepsis and initiate a sepsis evaluation, using the institutional, clinically-standard, sepsis pathway/orderset. After the CDS is triggered, it will use available Electronic Health Record data to calculate the risk of septic shock, using previously-published predictive models \[Ref 1, 2\]. The CDS will notify providers if the patient is at elevated risk of septic shock and prompt them to follow institutional standard care for septic shock (including close monitoring, complete laboratory evaluation for organ dysfunction, and immediate clinical involvement of an attending Pediatric Emergency Physician). All clinical care decisions will be determined by the providers.

OTHER

Clinical Diagnosis Only

Emergency Department sites in this arm will not have Clinical Decision Support for septic shock visible in the Electronic Health Record for providers at the site. Providers will follow usual institutional standards of sepsis care.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Halden F Scott, MD, MSCS · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065333 on ClinicalTrials.gov