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NCT Number: NCT07051668

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

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.

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Key information

Conditions

Sepsis Diagnosis Disease Disease Attributes Emergencies Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Halden Scott, MD

CONTACT

Halden Scott, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Sepsis Diagnostic Toolkit

Other

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 outcomes

  1. Accuracy

    Time frame: 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 outcomes

  1. Vital Signs Reported on Transfer Phone Call

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ALISON W. SAVILLE, MSW, MPH

CONTACT

[email protected]

7202574406

Halden F. Scott, MD, MSCS

CONTACT

[email protected]

215-520-7217

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

The Right Call: Implementing a Sepsis Diagnostic Safety Toolkit in a Pediatric Transfer Call Center to Improve Diagnosis of Children in General Emergency Settings

Acronym: RightCall

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 4, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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