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Recruiting NCT07051668

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

No phase Interventional Sepsis Diagnosis Emergencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pediatric Sepsis Diagnostic Toolkit.
Who it may be relevant to
Registry conditions: Sepsis, Diagnosis, Emergencies. Basic parameters: from 1 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Accuracy [Time frame: measured at the end of the 24 month post-implementation period]
Secondary outcome measures (1)
  • Vital Signs Reported on Transfer Phone Call [Time frame: measured at the end of the 24 month post-implementation period]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Children's Hospital Colorado — Aurora

Identifiers

NCT: NCT07051668 · 23-2340 · 1R18HS029786-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗