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

NCT05737420 | Completed

• 1 other identifier: SHS-Neuro-1-2023
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Recruitment Rate

  Rate of patients included in the trial amongst all patients screened

  Through study completion, approximately 2 months

• Exclusion rate

  rate of patients excluded from participation amongst all patients screened

  Through study completion, approximately 2 months

• Attrition rate

  rate of patients and data lost

  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

  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

  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

  At admission

• Stakeholder Feedback Survey

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

  immediately after the intervention

• 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 Outcomes (8)

• 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

• Duration of examination on video-call

  up to 60 minutes (prior to admission, prehospital phase)

Study Arms (2)

Interventional video call

EXPERIMENTAL

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.

Diagnostic Test: Video call

Control with standard care

NO INTERVENTION

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. .

Interventions

Video call DIAGNOSTIC_TEST

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

Interventional video call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• In-hospital stroke or private transport to hospital
• Unconsciousness defined as Glascow Coma Score (GCS) ≤ 8 (as they cannot be rated)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (2)

• 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.

  PMID: 33252631 BACKGROUND

• 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.

  PMID: 32250423 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Christian Backer Mogensen

  Hospital of Southern Denmark - Aabenraa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 21, 2023
• Study Start: July 6, 2023
• Primary Completion: October 6, 2023
• Study Completion: January 30, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)