Clinical trial NCT05737420: Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting
Official title: Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting: A Cluster Randomised Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Stroke
Nervous System Diseases
Vascular Diseases
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, approximately 2 months
measure: Exclusion rate
timeFrame: Through study completion, approximately 2 months
measure: Attrition rate
timeFrame: Through study completion, approximately 5 months
measure: Adherence to protocol by the Emergency Medical Services
timeFrame: Baseline (Prehospital examination of patient conducted by Emergency Medical Services)
measure: Adherence to protocol by the neurologist prehospital
timeFrame: Baseline (Prehospital examination of patient conducted on video by neurologists)
measure: Adherence to protocol by the neurologist intrahospital
timeFrame: At admission
measure: Stakeholder Feedback Survey
timeFrame: immediately after the intervention
measure: Patient Feedback Survey
timeFrame: Between the day after admission and 5 days after admission
Secondary outcomes:
measure: Acute ischemic stroke with Large Vessel Occlusion on neuroimaging
timeFrame: At admission
measure: Other large vessel Acute ischemic stroke
timeFrame: at admission
measure: Other Acute ischemic stroke
timeFrame: at admission
measure: Haemorrhagic stroke
timeFrame: at admission
measure: Duration of examination on video-call
timeFrame: up to 60 minutes (prior to admission, prehospital phase)
measure: Mimic mistaken for stroke
timeFrame: Through study completion, approximately 2 months
measure: Prehospital time on scene
timeFrame: up to 60 minutes (at prehospital contact)
measure: 90 days modified Rankin Scale
timeFrame: 90 days post admission date
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Soenderjylland
Study officials:
affiliation: Hospital of Southern Denmark - Aabenraa
name: Christian Backer Mogensen
role: STUDY_DIRECTOR
References:
citation: Nguyen TTM, van den Wijngaard IR, Bosch J, van Belle E, van Zwet EW, Dofferhoff-Vermeulen T, Duijndam D, Koster GT, de Schryver ELLM, Kloos LMH, de Laat KF, Aerden LAM, Zylicz SA, Wermer MJH, Kruyt ND. Comparison of Prehospital Scales for Predicting Large Anterior Vessel Occlusion in the Ambulance Setting. JAMA Neurol. 2021 Feb 1;78(2):157-164. doi: 10.1001/jamaneurol.2020.4418.
citation: Mazya MV, Berglund A, Ahmed N, von Euler M, Holmin S, Laska AC, Mathe JM, Sjostrand C, Eriksson EE. Implementation of a Prehospital Stroke Triage System Using Symptom Severity and Teleconsultation in the Stockholm Stroke Triage Study. JAMA Neurol. 2020 Jun 1;77(6):691-699. doi: 10.1001/jamaneurol.2020.0319.