Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Agreement in Assessment of Respiratory Distress
研究概览
简要总结
Teleconsultation, or the use of video telecommunications technology to deliver expert recommendations for care remotely, has been used to improve the safety and quality of emergency care for children in hospital-based acute care settings by providing real-time access to remote pediatric physician experts. Whether extending teleconsultation as a patient safety intervention to emergency medical systems (EMS) outside hospitals can similarly benefit sick and injured children in the community is unknown. Advances in mobile technology have made teleconsultation more accessible and affordable for EMS systems. However, this intervention has been underutilized by EMS partially due to the lack of prehospital research supporting its efficacy for pediatric applications.
In prior simulation studies, the investigators found high intervention acceptance among key stakeholder groups (pediatric emergency physicians and paramedics), and demonstrated that it was feasible to integrate video communication into prehospital clinical workflows involving critical care delivery in high-risk pediatric scenarios. These initial simulation studies were conducted in a controlled prehospital setting in static ambulances using infant simulator manikins to minimize risk to children and providers. Demonstrating feasibility and acceptability with real children in moving ambulances is the next step to build the necessary evidence base to support future planned prehospital efficacy trials with children.
The investigators hypothesize that remote respiratory assessment of children by medical control physicians (expert physicians) using a mobile teleconsultation platform is acceptable to users (physicians and transport providers), and technically feasible in real transports.
详细描述
An open-label, nonrandomized, pilot feasibility trial will be conducted of children with respiratory distress transported by the Boston Children's Hospital (BCH) critical care transport team that also serves Boston Medical Center (BMC). Transport providers will initiate a video-call from the ambulance to medical control physician on call who will be at a geographically distant location. The physician will view streamed video of the child and complete a brief respiratory assessment checklist tool to determine video quality, a feasibility measure.
The investigators will measure acceptability (primary outcome) and feasibility (secondary outcomes) on a validated questionnaire administered to users after each call. In this pilot study, efficacy will not be tested; all decision making will occur according to usual care protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in New England transported by the Boston Children Hospital for respiratory illness from any cause
- •Clinically stable for transportation [e.g., need supplemental oxygen, medications, or are stable on mechanical ventilation]
排除标准
- •Children with non-respiratory complaints
- •Children whose illness is anticipated by providers to be acutely life-threatening during transportation [e.g., requiring emergency resuscitation procedures in the ambulance]
- •Non-English speaking parents/guardians
研究组 & 干预措施
Teleconsultation group
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
干预措施: Teleconsultation (Other)
结局指标
主要结局
Agreement in Assessment of Respiratory Distress
时间窗: During transport to the hospital via ambulance, up to 4 hours
Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.
次要结局
- Percentage of Successful Tablet Mounts(Success/failure was assessed during transport, up to 4 hours)
- Total Usability Score(Immediately after the transport was completed, up to 48 hours)
- Video Quality(Immediately after the transport was completed, up to 48 hours)
- Audio Quality(immediately after the transport was completed, up to 48 hours)
- Adequacy of Successful Video-call Connections(immediately after the transport was completed, up to 48 hours)
- Percentage of Calls With Adequate Video Quality for Assessment(during ambulance transport, up to 4 hours)
- Time to Arrival at Referring Facility(up to 240 minutes)
- Scene Time(up to 240 minutes)
- Time to Arrival at Destination Facility(up to 240 minutes)
- Total Transport Time(up to 240 minutes)