跳至主要内容
临床试验/NCT07051668
NCT07051668招募中不适用

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

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Accuracy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Pre-implementation Phase (usual care)

No Intervention

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.

Post-implementation Phase (using Diagnostic Toolkit)

Active Comparator

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

干预措施: Pediatric Sepsis Diagnostic Toolkit (Other)

结局指标

主要结局

Accuracy

时间窗: 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.

次要结局

  • Vital Signs Reported on Transfer Phone Call(measured at the end of the 24 month post-implementation period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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