An interventional study of Pediatric Sepsis Diagnostic Toolkit in Sepsis, Diagnosis and Emergencies, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Diagnostic
Sepsis is a leading cause of death in children, and an early diagnosis that improves outcomes is less likely in children who are treated in general Emergency Departments (EDs), that treat adults and children, compared to pediatric Emergency Departments. The study team, in collaboration with invested clinicians and expert partners, has developed a pediatric sepsis diagnostic safety toolkit that we will implement in a pediatric health system's transfer call center. Preparation for launch of the toolkit will include education throughout Children's Hospital Colorado (CHCO), with a focus on transfer center nurses and accepting CHCO physicians who will be partnering in delivering the toolkit. Usual avenues for clinical education will be used, including meetings, endorsement from clinical leaders, emails, and physical materials such as badge and pocket cards. Referring Emergency Department (ED) providers outside of CHCO will not receive education about the toolkit by design, since they are the recipients of the toolkit which is designed to disseminate sepsis diagnostic knowledge in real time to general EDs within existing transfer workflows. This research will test whether the toolkit improves early pediatric sepsis diagnosis in general EDs where most children receive their first critical hours of care.
This study is a prospective type 2 hybrid implementation-effectiveness trial to evaluate a sepsis diagnostic safety toolkit. The study team will use explanatory mixed methods to assess quantitative and qualitative metrics, including PRISM contextual factors and RE-AIM outcomes such as accuracy, adoption, adaptations, sustainability, and context.
The study team will conduct a pre/post-evaluation of the toolkit to measure effectiveness outcomes; and also will evaluate additional implementation outcomes using quantitative and qualitative approaches.
The study will consist of a 24 month pre-intervention period and a 24-month post-intervention period, capturing the same sepsis seasonality during both phases.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 500 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Historic standards of care were used by all clinicians during the 24-month pre-implementation phase. This can also be referred to as usual care.
The Pediatric Sepsis Diagnostic Toolkit will be used during the post-implementation phase to better diagnose sepsis in transfer cases.
Other: Pediatric Sepsis Diagnostic Toolkit
The toolkit consists of the following items: 1) a recommendation to request and report vital signs in all pediatric hospital/ED transfers, 2) dissemination of evidence based pediatric sepsis diagnostic criteria to accepting and referring providers and transfer nurses, and 3) accepting physician education in conversational strategies to promote improved diagnostic accuracy during pediatric transfer conversations.
Accuracy
Proportion of included patients in whom all 3 of the following occur while the patient is physically in the referring hospital: 1) verbal or written use of the term "sepsis", 2) Intravenous antibiotics ordered,and 3) intravenous flue bolus ordered.
Time frame: measured at the end of the 24 month post-implementation period
Vital Signs Reported on Transfer Phone Call
Proportion of included patients with any vital sign reported during the transfer phone call.
Time frame: measured at the end of the 24 month post-implementation period
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Patient Electronic Health Record (EHR) data will be stored in Excel (csv) files for data analysis at University of Colorado. Cleaned and deidentified datasets in SAS or R statistical software will be shared upon request.
Supporting information: Study protocol, Sap
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University of Colorado, Denver