Clinical trial NCT05065333: Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Treatment in Pediatric Septic Shock
Official title: Implement and PREDICT Shock: An Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Critical Treatment in Pediatric Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Emergencies
Keywords: pediatric
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-10-04
Enrollment: 1345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a stepped wedge cluster randomized trial, with the site as the unit of randomization. There will be five study periods and four sites. In the first period no sites will receive the intervention. During each subsequent period, one site will crossover to receive the intervention.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Number of Patients Receiving Guideline-Concordant Septic Shock Care
timeFrame: Up to 24 hours after Emergency Department arrival
Secondary outcomes:
measure: Time to Antibiotics
timeFrame: Up to 24 hours after Emergency Department arrival
Other outcomes:
measure: 30-Day In-Hospital Mortality
timeFrame: 30 days after Emergency Department arrival
measure: Number of Patients Receiving Intravenous Antibiotics during Emergency Department care
timeFrame: Up to 24 hours after Emergency Department arrival
measure: Number of Patients With Septic Shock
timeFrame: Up to 24 hours after Emergency Department arrival
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Halden F Scott, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott HF, Colborn KL, Sevick CJ, Bajaj L, Kissoon N, Deakyne Davies SJ, Kempe A. Development and Validation of a Predictive Model of the Risk of Pediatric Septic Shock Using Data Known at the Time of Hospital Arrival. J Pediatr. 2020 Feb;217:145-151.e6. doi: 10.1016/j.jpeds.2019.09.079. Epub 2019 Nov 13.
citation: Scott HF, Colborn KL, Sevick CJ, Bajaj L, Deakyne Davies SJ, Fairclough D, Kissoon N, Kempe A. Development and Validation of a Model to Predict Pediatric Septic Shock Using Data Known 2 Hours After Hospital Arrival. Pediatr Crit Care Med. 2021 Jan 1;22(1):16-26. doi: 10.1097/PCC.0000000000002589.