Feasibility and Efficacy of Ambulance-Based m-Health for Pediatric Emergencies in Low Resource Settings (FEAMER) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 3
- 主要终点
- Change in Pediatric Early Warning Signs (PEWS) Score
研究概览
简要总结
Investigators hypothesize that in a low-resource setting, linking ambulances that transport acutely ill children to a remote pediatric emergency physician using a simple audio-video device will improve the quality of these children's medical decisions and health outcomes. For this purpose, the investigators will conduct a study in Karachi, Pakistan, where they will collect medical data for ill children at the time of ambulance pickup, hospital drop-off, and during hospital triage. During transport, one group will receive a telemedicine call from a trained physician, while the other group will receive basic paramedic treatment. The investigators will then compare both groups.
详细描述
Background:
Almost half of all 6.2 million deaths in children worldwide are caused by acute illnesses such as pneumonia, diarrhea, and injuries, and occur disproportionately in low- and middle-income countries (LMICs). These acute illnesses are mostly treatable if diagnosed and managed in a timely fashion. According to estimates, about half of these children can be saved through better emergency care.
Emergency medical care at the scene and during transportation is, therefore, critical to improving health outcomes. The "Chain of Survival" for cardiac arrest, the "Golden hour" of trauma, and the "FAST" program for stroke rely heavily on high-quality Emergency Medical Systems (EMS). For many emergency conditions, triage and care decisions during transportation play a critical role in the eventual outcome. EMS staff well-trained in pediatric acute/emergency care are scarce, even in high-income countries, and essentially non-existent in LMICs.
There is a critical need - globally, but particularly in LMICs - to address this expertise gap during the most critical time period while a child is transported to a fixed emergency care facility. Such solutions can contribute to potentially saving thousands of children every year.
Formal EMS systems consist of a universal access number (such as 911) that connects the community to ambulances equipped with the necessary supplies, protocols, and, most importantly, trained healthcare providers through specialized call centers. In low-resource settings, the contribution of effective transportation to health outcomes becomes far more significant. Studies show that the lack of EMS contributed to two-thirds of all trauma deaths, 52% of maternal and perinatal deaths, and 20% of newborn deaths in LMICs. Mobile health technology available today has the potential to bridge the expertise gap in prehospital settings rapidly. While there is a sound theoretical basis for such intervention, there is no evidence on the use of ambulance-based teleconsultation (ABT) for children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •Age 0-14 years
- •Children transported by an SIEHS ambulance with a transport time of ≥20 minutes
- •Children presenting to the ChildLife Emergency Department with a parent/ guardian present in the ambulance to consent
- •Children classified as "Charlie, Delta, Echo" on the Medical Priority Dispatch System
排除标准
- •Children transported without an adult parent or guardian
- •EMERGENCY MEDICAL TECHNICIANS (EMTs)
- •Inclusion Criteria:
- •EMTs currently employed by the SIEHS EMS service.
- •Exclusion Criteria:
- •EMTs who refuse to participate or consent to the study.
- •TELEMEDICINE PHYSICIANS (TMPs)
- •Inclusion Criteria:
- •TMPs currently employed by the CLF Telemedicine services.
- •Exclusion Criteria:
- •TMPs who refuse to participate or consent to the study.
结局指标
主要结局
Change in Pediatric Early Warning Signs (PEWS) Score
时间窗: At the ambulance pick up and hospital drop off (>20 minutes)
PEWS Score is "0" for a normal patient, and ranges between "1-9" depending upon severity of illness i.e., higher PEWS scores referring to higher severity of illness. Modified Brighton PEWS used in our study accounts for Respiratory rate, Heart Rate, and Appearance.
Pediatric Early Warning Signs (PEWS) Score at the ambulance drop off
时间窗: At the ambulance drop off (>20 minutes)
PEWS Score is "0" for a normal patient, and ranges between "1-9" depending upon severity of illness i.e., higher PEWS scores referring to higher severity of illness. Modified Brighton PEWS used in our study accounts for Respiratory rate, Heart Rate, and Appearance.
次要结局
- Percent of completed Telemedicine Calls(During ambulance ride (>20 minutes))
- Satisfaction of Emergency Medical Technicians and Telemedicine Physicians as measured by the System Usability Survey(1 month after the end of trial i.e., completion of study)
- Outcome at end of Emergency Department (ED) Visit(On arrival to the ED triage)
- 72 hour outcome after the Emergency Department (ED) Visit(Within 72 hours of reaching the ED)