Video Call Assisted Assessment of Acute Stroke

Video Call Assisted Assessment of Acute Stroke in Addition to Stroke Scales in a Prehospital Setting: A Cluster Randomised Controlled Trial

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical technicians can increase feasibility and performance of symptom-based prehospital stroke scales.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases
• Intervention / Treatment: Diagnostic test: Video call assisted assessment of acute stroke

Detailed Description

Treatment of stroke with either thrombolysis or thrombectomy is highly time-dependent (administration within 4.5 hours and 24 hours from symptom onset, respectively), and morbidity and mortality increase with time from symptom onset to treatment. Hence, prehospital evaluation and transport must be as accurate and rapid as possible in order to minimise time to treatment.

Different triage and transport paradigms for patients with suspected stroke are being investigated and multiple stroke scales have been coined in order to examine patients suspected of stroke in a prehospital setting. 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 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 video call assisted assessment of patients suspected of stroke in a prehospital setting can increase feasibility and performance of symptom-based prehospital stroke scales.

• Study Type: Interventional
• Enrollment (Estimated): 512
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trine Nielsen; Phone Number: +45 79 97 00 00; Email: Trine.Nielsen2@rsyd.dk
• Study Contact Backup: Name: Christian Backer Mogensen; Phone Number: +45 79 97 00 00; Email: CBM1@rsyd.dk

Study Locations

• Denmark
  • Region Syddanmark
    • Aabenraa, Region Syddanmark, Denmark, 6200
      • Recruiting
      • Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Suspected stroke within 24 hours from onset (confirmed with Prehospital Stroke 1 decision tool)
• Age >18 years

Exclusion Criteria:

• Suspected stroke more than 24 hours ago
• In-hospital stroke or private transport to hospital
• Unconsciousness defined as Glasgow Coma Score (GCS) ≤ 8 (as they cannot be rated)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; If the patient is eligible for study inclusion, eight symptoms from the study protocol are evaluated and registered in the Prehospital Patient Journal (PPJ) on the amPHITM Prehospital Health Care Record (Amphi Systems, Hasserisvej 125, 9000 Aalborg, Denmark), on a tablet mounted in each EMT vehicle. If the vehicle is in the control arm the patient is triaged by the on-call neurologist based on a standard telephone call
Active Comparator: Video call assisted assessment of acute stroke; If the patient is eligible for study inclusion, the last symptoms from the study protocol are evaluated and registered in the Prehospital Patient Journal (PPJ) on the amPHITM Prehospital Health Care Record (Amphi Systems, Hasserisvej 125, 9000 Aalborg, Denmark), on a tablet mounted in each EMT vehicle. Afterwards the EMS personnel will contact the on-call neurologist and if the vehicle is in the intervention arm a live video stream is initiated. The on-call neurologist then examines the patient via the video-call and triage the patient.	Diagnostic test: Video call assisted assessment of acute stroke; If the patient is eligible for study inclusion, eight symptoms from the study protocol are evaluated and registered in the Prehospital Patient Journal (PPJ) on the amPHITM Prehospital Health Care Record (Amphi Systems, Hasserisvej 125, 9000 Aalborg, Denmark), on a tablet mounted in each EMT vehicle. Afterwards, the EMS personnel will contact the on-call neurologist and if the vehicle is in the intervention arm a live video stream is initiated. The on-call neurologist then examines the patient via via the video-call and triages the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge	AIS or TIA as diagnosis. (binary outcome)	At discharge, assessed within one week from symptom onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with acute ischemic stroke (AIS) with LVO on neuroimaging	AIS with LVO on neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography). LVO is defined as a occlusion or sub-occlusion of the intracranial internal carotid artery, middle cerebral artery M1 or M2, basilar artery. Sign of dense cerebral artery on CT is also considered LVO positive. (binary outcome).	Within 48 hours of admission
Number of patients with Other large vessel AIS	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 (binary outcome).	at admission
Number of patients with verified acute ischemic stroke (AIS) on neuroimaging	Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS	Within 48 hours of admission
Number of patients with Haemorrhagic stroke	Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH) (binary outcome)	at admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of examination on video-call	Duration of examination on video-call measured in minutes (continuous outcome)	up to 120 minutes prior to admission (prehospital phase)
Number of patients which have 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
Prehospital time on scene	Time on scene from arrival EMS to departure EMS measured in minutes (continuous outcome)	up to 120 minutes prior to admission (prehospital phase)
Type of department patient is admitted to after consultation with the neurologist	Where was the patient sent after telephone/video consultation with the on-call neurologist.	At admission
Door-in-door-out (DIDO) time	DIDO times for patients subsequently sent to comprehensive stroke unit for thrombectomy treatment.	at admission
Door-to-needle (DNT) time	DNT times for patients receiving thrombolysis	at admission
Door-to-Groin-Puncture (DTGP) time	DTGP times for patients receiving treatment with thrombectomy	within 24 hours of admission
Onset-to-Groin-Puncture (OTP) time	OTP for patients receiving treatment with thrombectomy	within 24 hours of admission
90 days modified Ranking Scale (mRS)	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

Collaborators and Investigators

• Sponsor: University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 3, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Stroke; Vascular Diseases; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: SHS-Neuro-1-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No