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

Stroke Clinical Trial

Official title:

Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting: A Cluster Randomised Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05737420
• Other study ID #: SHS-Neuro-1-2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: January 2024
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Video call
The on-call neurologist can see and communicate with the patient via live stream video-call.

Locations

Country	Name	City	State
Denmark	Sygehus Soenderjylland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Rate of patients included in the trial amongst all patients screened	Through study completion, approximately 2 months
Primary	Exclusion rate	rate of patients excluded from participation amongst all patients screened	Through study completion, approximately 2 months
Primary	Attrition rate	rate of patients and data lost	Through study completion, approximately 5 months
Primary	Adherence to protocol by the Emergency Medical Services	Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal	Baseline (Prehospital examination of patient conducted by Emergency Medical Services)
Primary	Adherence to protocol by the neurologist prehospital	Evaluation of missing data in the clinical examination conducted with video	Baseline (Prehospital examination of patient conducted on video by neurologists)
Primary	Adherence to protocol by the neurologist intrahospital	Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist	At admission
Primary	Stakeholder Feedback Survey	Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability	immediately after the intervention
Primary	Patient Feedback Survey	Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability	Between the day after admission and 5 days after admission
Secondary	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.	At admission
Secondary	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	at admission
Secondary	Other Acute ischemic stroke	Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke	at admission
Secondary	Haemorrhagic stroke	Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH)	at admission
Secondary	Duration of examination on video-call	Duration of examination on video-call measured in minutes	up to 60 minutes (prior to admission, prehospital phase)
Secondary	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	Through study completion, approximately 2 months
Secondary	Prehospital time on scene	Time on scene from arrival of Emergency Medical Services to departure of Emergency Medical Services measured in minutes	up to 60 minutes (at prehospital contact)
Secondary	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	90 days post admission date