Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency
研究概览
简要总结
The goal of this clinical trial is to compare a telemedicine neurologist staffing model to a traditional on-board model in patients being assessed for suspected acute stroke on a mobile stroke unit.
详细描述
This study is a prospective randomized mobile stroke unit trial comparing two staffing models: 1) a neurologist reviewing the patient via telemedicine (intervention) versus 2) an onboard neurologist assessing the patient in-person (comparator). Daily periods of remote (telemedicine) or in person (onboard) neurologist assessments will be randomly determined using an adaptive design.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >=18 years of age
- •Presenting within 24 hours of symptom onset or last known well.
- •Patients assessed by MSU without cancellation (either by the local ambulance team or by MSU) prior to attending the patient.
排除标准
- •Attendance of the Melbourne MSU is deemed unnecessary by either the local paramedic team or the MSU team based on provided information prior to arrival on scene.
- •The patient presents significant medical or logistical challenges which greatly delay standard treatment.
- •Any other medical contraindication at the discretion of the investigator.
结局指标
主要结局
Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency
时间窗: See pre-specified outcome section for details
The odds that a random participant treated through a telemedicine assessment will have a more desirable DOOR scale outcome than a random participant treated by an onboard neurologist. Such a odds is referred to as the Win Ratio, as it reflects the odds of a random participant treated via telemedicine "winning" against a random participant treated via an onboard model in a direct one-to-one comparison. The design evaluates, in order of importance: Safety, Scene-to-decision time metrics, Resource efficiency If a participant in one treatment arm is achieving better safety than the comparator, this is defined as a "win" for that participant and a "loss" for the comparator. If there is no difference in safety, time to treatment decision is compared. If no clinically meaningful difference is observed, then resource utilization is compared. If there is no difference in resource utilization, the two participants are declared as tied for the overall outcome.
次要结局
- On-scene to eyes-on-patient (for the neurologist)(Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene))
- On-scene to imaging review by the neurologist(Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene))
- On-scene to imaging(Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene))
- 90-Day mRS(90 days (+/- 10 days from symptom onset))
- On-scene to definitive decision making(Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene))