NCT05065333

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

Implement and PREDICT Shock: An Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Critical Treatment in Pediatric Septic Shock

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,345 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Septic Shock
• Emergencies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2021-10-04
• Last updated: 2023-04-19

Locations

1 site across 1 country: United States