Smart Triage: Triage and Management of Sepsis in Children Using the Point-of-care Paediatric Rapid Sepsis Trigger (PRST) Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,693
- 试验地点
- 3
- 主要终点
- Time to Administration of an Appropriate Antimicrobial
研究概览
简要总结
Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent these challenges, we propose the development and clinical evaluation of a trigger tool that will reduce the time to diagnosis and prompt the timely initiation of life-saving treatment. The key innovations are 1) a data-driven approach to rapid diagnosis of sepsis severity and 2) a low- cost digital tagging system to track the time to treatment. The tool will require minimal cost, clinical expertise and training or time to use.
The tool will identify high risk children and reduce time to treatment. The digital platform (mobile device and dashboard) will create a low-cost, highly scalable solution for children with sepsis.
详细描述
This is a pre-post intervention study involving pediatric patients presenting to the study hospitals in seek of medical care for an acute illness. The study involves three phases: (I) Baseline Period, (II) Interphase Period, (III) Intervention Period.
Phase I (3-6 months) will be a prospective observational cohort at Mbagathi County Hospital in Nairobi, Kenya, and Jinja Regional Referral Hospital in Jinja, Uganda. During this period, there will be no changes to healthcare delivery procedures in the study hospitals. Triage will continue to be performed by hospital staff using Emergency Triage and Treatment (ETAT) guidelines, the system that is currently in effect at the study hospitals. Data collection will be undertaken in the triage waiting area. While participants are waiting for their turn to be seen by the hospital triage nurses, our trained study nurses will collect data on a pre-selected list of predictor variables. These data will be used to develop a clinical prediction model based on the need for hospital admission.
Control Site (Phase I, 12 months): Kiambu County Referral Hospital in Nairobi, Kenya will serve as the control site and no intervention will be implemented. At this site, Phase I will commence for a period of 12 months. There will be no Phase II or Phase III.
Phase II (1-3 months) will involve technology development, usability testing, and training.
Phase IIa: Technology Development. A risk prediction model will be derived using the data collected in Phase I and implemented in a Digital Triaging Platform, along with a digitized version of the ETAT+ guidelines. The Digital Triaging Platform, including vital sign measurement devices (PhoneOx and RRate and the mobile application and clinical dashboard has already been developed and evaluated. Once the digital triage tool has been developed, it will be evaluated in potential users using simulated patient scenarios and a 'Think Aloud' method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the clinical pre-post intervention design, masking will not be possible.
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All paediatric outpatients presenting to the study hospitals for medical treatment. The lower age limit will include children aged from 0 days, and the upper age limit will be in accordance to respective hospitals' practice for paediatric admissions (this may be 12, 15 or 19 years).
- •Informed parental/guardian consent provided.
- •Assent from children older than 13 years in addition to parental/guardian consent provided.
排除标准
- •Patients presenting to the outpatient department for elective cases (e.g. elective surgery or change of dressing) or for clinical review appointment.
结局指标
主要结局
Time to Administration of an Appropriate Antimicrobial
时间窗: 1 day
Time in minutes to administer an appropriate antimicrobial, which includes at least one antibiotic or antimalarial (treatment determined and administered by hospital staff). The time is measured from when the child arrives at the facility (time of the first registration) until the antimicrobial administration is started.
次要结局
未报告次要终点
研究者
(John) Ansermino
Principal Investigator
University of British Columbia