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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Emergencies; Septic Shock; Sepsis

Treatments: Other: Clinical Diagnosis Only; Other: Septic Shock Clinical Decision Support

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05065333

K08HS025696 (U.S. AHRQ Grant/Contract)

21-2916

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,345 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Emergency Department 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

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,345 participants in 2 patient groups

Septic Shock Clinical Decision Support

Experimental group

Description:

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.

Treatment:

Other: Septic Shock Clinical Decision Support

Clinical Diagnosis Only

Active Comparator group

Description:

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.

Treatment:

Other: Clinical Diagnosis Only