Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting: A Cluster Randomised Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Stakeholder Feedback Survey
Study Overview
Brief Summary
This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •In-hospital stroke or private transport to hospital
- •Unconsciousness defined as Glascow Coma Score (GCS) ≤ 8 (as they cannot be rated)
Arms & Interventions
Interventional video call
All patients suspected of stroke in a prehospital setting are examined according to a prehospital stroke score. The emergency services personnel then contact the on-call neurologist and a live video stream is initiated. The on-call neurologist then examines the patient via the video-call.
Intervention: Video call (Diagnostic Test)
Control with standard care
All patients suspected of stroke in a prehospital setting are examined according to a prehospital stroke score. The emergency services personnel then contact the on-call neurologist by telephone. .
Outcomes
Primary Outcomes
Stakeholder Feedback Survey
Time Frame: immediately after the intervention
Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability
Adherence to protocol by the neurologist intrahospital
Time Frame: At admission
Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist
Exclusion rate
Time Frame: Through study completion, approximately 2 months
rate of patients excluded from participation amongst all patients screened
Patient Feedback Survey
Time Frame: 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
Time Frame: Baseline (Prehospital examination of patient conducted by Emergency Medical Services)
Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal
Recruitment Rate
Time Frame: Through study completion, approximately 2 months
Rate of patients included in the trial amongst all patients screened
Attrition rate
Time Frame: Through study completion, approximately 5 months
rate of patients and data lost
Adherence to protocol by the neurologist prehospital
Time Frame: Baseline (Prehospital examination of patient conducted on video by neurologists)
Evaluation of missing data in the clinical examination conducted with video
Secondary Outcomes
- 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)