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

Not Applicable

Completed

• Conditions: Sepsis; Emergencies; Septic Shock
• Interventions: Other: Septic Shock Clinical Decision Support; Other: Clinical Diagnosis Only

• Registration Number: NCT05065333
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Septic shock is a leading global cause of pediatric death. In the US, the in-hospital mortality rate for children with sepsis is 5-20%. Septic shock is a state of critical infection that requires advanced and resource-intensive resuscitation, and morbidity-free survival depends on timely diagnosis. Critical care delivered in a delayed fashion, after a child is in hypotensive shock, is less effective; for each hour of unrecognized shock the odds of death more than double. Advances have been made in timely sepsis treatment, but improving diagnosis of septic shock in children remains elusive. Improved early diagnosis would accelerate treatment and improve outcomes.

Tools that have been deployed to improve diagnosis in pediatric sepsis either diagnose it after organ dysfunction criteria have been met, or depend heavily on subspecialty physician judgment and have not been tested outside of tertiary pediatric hospitals. Thus, the evidence-based 2020 Surviving Sepsis Children's Guidelines for pediatric sepsis stated that "high-quality trials on pediatric sepsis recognition are lacking, and data are not sufficient to suggest any particular screening tool," and identified pediatric sepsis recognition trials as an important research need. Despite this, the guidelines weakly recommended screening patients "who present as acutely unwell" for septic shock, citing very low quality evidence. The guidelines also stated that there is no evidence for the effectiveness of any existing pediatric sepsis screening tools.

This study addresses the gap in knowledge about the effectiveness of pediatric sepsis prediction tools. The study team has developed and retrospectively validated early diagnostic models that leverage clinical data in the Electronic Health Record (EHR) to predict septic shock in children the emergency setting \[1, 2\]. In order to address concerns about alert fatigue and antibiotic overuse, these predictive models were designed to identify patients at high risk for shock among patients in whom clinicians initially had some suspicion for sepsis.

In this pilot implementation trial, Clinical Decision Support based on septic shock prediction models will be introduced to 4 pediatric Emergency Departments (EDs) within the Children's Hospital Colorado care system in a stepped wedge design, in addition to routine clinical care. Routine clinical care at all study sites includes existing sepsis pathways, order sets, and quality metrics that are aligned with the national Improving Pediatric Sepsis Outcomes Collaborative and the Pediatric Surviving Sepsis guidelines. 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.

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-04
• Study Start: 2022-03-16
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1345

Inclusion Criteria

• Children's Hospital Colorado Emergency Care sites
• All providers (physicians, nurse practitioners, physician assistants) at Children's Hospital Colorado Emergency Care sites will be included

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Exclusion Criteria

• None

Patients whose secondary data will be used to assess the outcomes of the intervention will be 60 days through 18 years old.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Septic Shock Clinical Decision Support	Septic Shock Clinical Decision Support	Emergency Department sites in this arm will have Clinical Decision Support (CDS) alerts active in the Electronic Health Record during clinical ED care of patients with suspected sepsis, in addition to following usual institutional standard of care for sepsis. The CDS will alert providers to patients at high risk for developing septic shock.
Clinical Diagnosis Only	Clinical Diagnosis Only	Emergency Department sites in this arm will follow the institutional standard for sepsis care without Clinical Decision Support. Standard care includes clinical diagnosis of sepsis supported by institutional sepsis education, a sepsis pathway and orderset.

Primary Outcome Measures

Name	Time	Method
Number of Patients Receiving Guideline-Concordant Septic Shock Care	Up to 24 hours after Emergency Department arrival	Treatment will be defined as concordant with Surviving Sepsis Campaign guidelines for shock if intravenous antibiotics are initiated within 60 minutes of sepsis recognition and an intravenous fluid bolus is initiated within 60 minutes of sepsis recognition. This will be a binary outcome. Sepsis recognition is defined as the earlier of: sepsis page sent, sepsis orderset use, or intravenous antibiotic order.

Secondary Outcome Measures

Name	Time	Method
Time to Antibiotics	Up to 24 hours after Emergency Department arrival	Time to antibiotics will be measured in minutes from the time of sepsis recognition to the start of intravenous antibiotic treatment. This will be a time-to-event outcome. Sepsis recognition is defined as the earlier of: sepsis page sent, sepsis orderset use, or intravenous antibiotic order.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States