Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting

University of Southern Denmark33 enrolled

Overview

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Stroke Nervous System Diseases Vascular Diseases

Interventions

Video callDIAGNOSTIC_TEST

The on-call neurologist can see and communicate with the patient via live stream video-call.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Sygehus Soenderjylland

Aabenraa, Denmark

Outcomes

Primary Outcomes

Recruitment Rate

Rate of patients included in the trial amongst all patients screened

Time frame: Through study completion, approximately 2 months

Exclusion rate

rate of patients excluded from participation amongst all patients screened

Time frame: Through study completion, approximately 2 months

Attrition rate

rate of patients and data lost

Time frame: Through study completion, approximately 5 months

Adherence to protocol by the Emergency Medical Services

Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal

Time frame: Baseline (Prehospital examination of patient conducted by Emergency Medical Services)

Adherence to protocol by the neurologist prehospital

Evaluation of missing data in the clinical examination conducted with video

Time frame: Baseline (Prehospital examination of patient conducted on video by neurologists)

Adherence to protocol by the neurologist intrahospital

Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist

Time frame: At admission

Stakeholder Feedback Survey

Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability

Time frame: immediately after the intervention

Patient Feedback Survey

Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability

Data from ClinicalTrials.gov

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Secondary Outcomes

Acute ischemic stroke with Large Vessel Occlusion on neuroimaging

Acute ischemic stroke with Large Vessel Occlusion (LVO) on neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography). LVO is defined as an occlusion or sub-occlusion of the intracranial internal carotid artery, middle cerebral artery M1 or M2, basilar artery. Sign of a dense cerebral artery on CT is also considered LVO positive.

Time frame: At admission

Other large vessel Acute ischemic stroke

Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS with occlusion or sub-occlusion of either anterior cerebral artery A1 or A2, posterior cortical artery P1 or intracranial vertebral artery

Time frame: at admission

Other Acute ischemic stroke

Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke

Time frame: at admission

Haemorrhagic stroke

Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH)

Time frame: at admission

Duration of examination on video-call

Duration of examination on video-call measured in minutes

Time frame: up to 60 minutes (prior to admission, prehospital phase)

Mimic mistaken for stroke

Mimic mistaken for stroke evaluated as discrepancy between stroke as tentative diagnoses at primary contact from EMS and final diagnosis at discharge

Time frame: Through study completion, approximately 2 months

Prehospital time on scene

Time on scene from arrival of Emergency Medical Services to departure of Emergency Medical Services measured in minutes

Time frame: up to 60 minutes (at prehospital contact)

90 days modified Rankin Scale

Modified Rankin Scale score in stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment

Time frame: 90 days post admission date