SatCare: Remote Support for Ambulance Clinicians in Medical Emergencies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- EQ-5D-5L (EuroQol five dimension, five level) score three months after the initial ambulance episode
研究概览
简要总结
SatCare is a randomised controlled trial involving rapid standardised ultrasound assessment of patients with shock, major trauma, abdominal pain, chest pain or breathlessness in emergency ambulances. The scans will take less than 5 minutes and be transmitted to a hospital-based expert for review, providing support and instructions for optimal prehospital care.
Five Highland Scottish Ambulance Service ambulances covering areas more than 30 minutes from Raigmore Hospital, Inverness, UK, will be equipped with an ultrasound machine (M-Turbo, FujiFilm Sonosite) and satellite transmission system plus webcam, and will be deployed in real emergency situations. When dispatched to a potentially eligible patient, the attending paramedic will contact Raigmore Hospital's emergency department to check the availability of an emergency medicine specialist and obtain study group allocation (ultrasound with enhanced telecommunications plus usual care versus usual care alone). Following verbal consent from the patient, trained paramedics will perform the condition-specific scan protocol in the ambulance at the incident site, and transmit the recordings and patient video via satellite to the emergency department for specialist analysis. The consultant will give advice on patient management via standard ambulance communications systems while it is en route to the hospital.
The remotely supported prehospital ultrasound implementation will be examined in terms of its delivery and functioning. An economic evaluation will compare its use with care as usual for eligible patients transported by ambulance, modelling the costs and benefits of this service expansion and determining optimum use. It is hoped that the results, anticipated to be available in 2019, will provide an evidence base for the use of prehospital ultrasound for emergency care.
详细描述
Research objectives:
- To assess the patient health impact of enhanced telecommunications and remotely-supported point-of-care ultrasound scanning (RS-POCUS) in prehospital situations
- To assess the impact of introducing this intervention on current care systems, via interviews with various stakeholders involved in the trial (e.g., patients, paramedics, emergency medicine consultants, hospital management, etc.) and health economic modelling
Research questions:
- What is the health gain, as assessed by the EQ-5D-5L (EuroQol five dimension questionnaire, 5-level version) score at three months, associated with the use of enhanced telecommunications and RS-POCUS?
- What is the estimated cost-per-QALY associated with the prehospital RS-POCUS?
- Where in the care system and in which situations does the intervention produce the greatest impact?
- How does the use of RS-POCUS affect time to definitive treatment in the studied patient groups?
Patient Randomisation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with:
- •significant trauma: any case where the mechanism of injury, anatomical defect or physiological upset triggers the paramedic to pre-alert a 'trauma call' to the receiving Emergency Department
- •chest pain: pain felt below the clavicles and above the costal margin, whether anterior or posterior
- •shortness of breath: any patient complaining of 'shortness of breath' or with paramedic examination positive for 'respiratory distress' whether by increased respiratory rate, effort or both
- •abdominal pain: any pain felt below the costal margin and above the bony pelvis
- •cardiovascular shock of unknown origin: either a systolic blood pressure below 100 mmHg or any symptoms or signs of syncope on elevation of the head, cool peripheries or extended capillary refill time
- •Attended by a study ambulance
- •Recruitment occurs within the hours supported by the Emergency Department: Monday to Friday, 09:00 to 17:00
排除标准
- •Non-emergency ambulance transfers
- •General practitioner requested emergency ambulances
- •Patients under arrest or held in prison
- •No potential value in performing ultrasound (e.g., none of the diagnoses listed above)
- •Lack of consent for scan (if in intervention arm)
- •Lack of capacity to consent to scan / no patient representative to provide consent
- •Evidence of any condition leading to lack of capacity to give informed consent prior to the commencement of the study, as documented on the patient's electronic patient record
- •Non-English speakers
- •Outside the emergency department supported hours (Monday to Friday, 09:00 to 17:00)
- •Paramedic decision to exclude patient, for reasons such as urgency of transport (i.e., where thorough on-scene evaluation would not normally be offered) or other lack of suitability
结局指标
主要结局
EQ-5D-5L (EuroQol five dimension, five level) score three months after the initial ambulance episode
时间窗: 3 months post recruitment
The EQ-5D-5L questionnaire includes assessments of mobility, self-care, daily activities undertaken, pain, discomfort, anxiety and depression.Completion of the EQ-5D-5L leads to the establishment of 243 distinct states, each with corresponding numerical quality of life value.
次要结局
- Process evaluation (to investigate intervention use, acceptance and optimisation)(15 months)
- Costs to the NHS(15 months)
- Time from ambulance arrival at scene to definitive treatment or discharge(up to 3 months post recruitment)
- Cost per QALY (Quality Adjusted Life Year)(3 months post recruitment)
- Mortality rate(up to 3 months post recruitment)
- Relative efficiency calculations (cost-consequences analysis)(15 months)
- Communications system connection speed(15 months)
- Communications system data upload rate(15 months)
- Patient and staff satisfaction with the intervention(15 months)