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

NCT ID: NCT07051668

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2027-07-31

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.

Conditions

Sepsis; Diagnosis; Emergencies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Pediatric Sepsis Diagnostic Toolkit

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Halden F. Scott, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Halden F. Scott, MD, MSCS

Role: CONTACT

halden.scott@cuanschutz.edu

215-520-7217

ALISON W. SAVILLE, MSW, MPH

Role: CONTACT

alison.saville@cuanschutz.edu

7202574406

Facility Contacts

Halden Scott, MD

Role: primary

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R18HS029786-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

23-2340

Identifier Type: -

Identifier Source: org_study_id