The RightCall: Implementing a Sepsis Diagnostic Toolkit to Improve Pediatric Diagnosis in ED Transfer Calls

Not Applicable

Recruiting

• Conditions: Sepsis; Diagnosis; Emergencies

• Registration Number: NCT07051668
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Study First Posted: 2025-07-04
• Study Start: 2025-07-08
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Accuracy	measured at the end of the 24 month post-implementation period	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.

Secondary Outcome Measures

Name	Time	Method
Vital Signs Reported on Transfer Phone Call	measured at the end of the 24 month post-implementation period	Proportion of included patients with any vital sign reported during the transfer phone call.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States