Recruiting

Pediatric Sepsis Toolkit

Sponsor:

University of Colorado, Denver

Code:

NCT07051668

Conditions

Sepsis

Diagnosis

Emergencies

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Pediatric Sepsis Diagnostic Toolkit

Study Details

Brief summary:

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.

Conditions

Sepsis

Diagnosis

Emergencies

Study ID

NCT07051668

Start date

Jul 8, 2025

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients transferred to Children's Hospital Colorado (CHCO) for emergency or inpatient care, as identified in the extant CHCO transfer center database AND in the extant CHCO quality improvement sepsis database AND one of the following:
  • Patients who met Phoenix sepsis criteria 1) in the referring ED, 2) during transport, 3) in the first 6 hours after arrival at the pediatric hospital, or 4) patients who developed Phoenix sepsis within 24 hours of arrival at the Children's Hospital underwent independent physician review by three emergency physicians. Patients in whom all three physicians agreed sepsis was most likely present, using the structured SaferDx tool were included

Exclusion Criteria:

  • Patients less than one month of age
  • Patients whose transfer call recording was not available in the database

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Pre-implementation Phase (usual care)

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.

active comparator: Post-implementation Phase (using Diagnostic Toolkit)

The Pediatric Sepsis Diagnostic Toolkit will be used during the post-implementation phase to better diagnose sepsis in transfer cases.

Interventions

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.

Primary outcome measure

  • Accuracy [ Time Frame: measured at the end of the 24 month post-implementation period ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Halden Scott, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Keywords

  • Pediatric, Diagnosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-08-15.