Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting: A Cluster Randomised Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Stakeholder Feedback Survey
研究概览
简要总结
This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.
详细描述
Multiple stroke severity scales have been coined in order to examine patients suspected of stroke in a prehospital setting in order to identify and transfer patients eligible for thrombectomy directly to a comprehensive stroke centre (CSC). However, performance and feasibility vary greatly in different validation studies suggesting that those outcomes are greatly dependent on other factors i.e. acceptance amongst stakeholders, implementation process, patient segment etc. Some recent studies have shown promising results using telemedicine i.e. video solutions between emergency medical services (EMS) personnel and on-call neurologist in examining patients suspected of stroke in the prehospital phase. The investigators will perform this trial to examine whether a cluster randomised trial with video call assisted assessment of patients suspected of stroke in a prehospital setting is an appropriate trial design and feasible with regard to recruitment and retention, acceptability among stakeholders (EMS and neurologists) as well as patients and lastly with regard to stakeholders' adherence to protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Suspected stroke within 24 hours from onset (confirmed with Pre-hospital stroke score 1 ≥1)
- •Catchment area of Hospital Sønderjylland
- •Deferred informed consent obtained from patient or patient surrogate
排除标准
- •In-hospital stroke or private transport to hospital
- •Unconsciousness defined as Glascow Coma Score (GCS) ≤ 8 (as they cannot be rated)
结局指标
主要结局
Stakeholder Feedback Survey
时间窗: immediately after the intervention
Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability
Exclusion rate
时间窗: Through study completion, approximately 2 months
rate of patients excluded from participation amongst all patients screened
Patient Feedback Survey
时间窗: Between the day after admission and 5 days after admission
Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability
Adherence to protocol by the Emergency Medical Services
时间窗: Baseline (Prehospital examination of patient conducted by Emergency Medical Services)
Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal
Adherence to protocol by the neurologist intrahospital
时间窗: At admission
Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist
Recruitment Rate
时间窗: Through study completion, approximately 2 months
Rate of patients included in the trial amongst all patients screened
Attrition rate
时间窗: Through study completion, approximately 5 months
rate of patients and data lost
Adherence to protocol by the neurologist prehospital
时间窗: Baseline (Prehospital examination of patient conducted on video by neurologists)
Evaluation of missing data in the clinical examination conducted with video
次要结局
- Duration of examination on video-call(up to 60 minutes (prior to admission, prehospital phase))
- Mimic mistaken for stroke(Through study completion, approximately 2 months)
- Acute ischemic stroke with Large Vessel Occlusion on neuroimaging(At admission)
- Other large vessel Acute ischemic stroke(at admission)
- Other Acute ischemic stroke(at admission)
- Haemorrhagic stroke(at admission)
- Prehospital time on scene(up to 60 minutes (at prehospital contact))
- 90 days modified Rankin Scale(90 days post admission date)