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

Primary Purpose

Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Video call
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebrovascular Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sygehus SoenderjyllandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional video call

Control with standard care

Arm Description

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.

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. .

Outcomes

Primary Outcome Measures

Recruitment Rate
Rate of patients included in the trial amongst all patients screened
Exclusion rate
rate of patients excluded from participation amongst all patients screened
Attrition rate
rate of patients and data lost
Adherence to protocol by the Emergency Medical Services
Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal
Adherence to protocol by the neurologist prehospital
Evaluation of missing data in the clinical examination conducted with video
Adherence to protocol by the neurologist intrahospital
Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist
Stakeholder Feedback Survey
Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability
Patient Feedback Survey
Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability

Secondary Outcome Measures

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.
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
Other Acute ischemic stroke
Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke
Haemorrhagic stroke
Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH)
Duration of examination on video-call
Duration of examination on video-call measured in minutes
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
Prehospital time on scene
Time on scene from arrival of Emergency Medical Services to departure of Emergency Medical Services measured in minutes
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

Full Information

First Posted
February 6, 2023
Last Updated
July 28, 2023
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05737420
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Stroke, Nervous System Diseases, Vascular Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional video call
Arm Type
Experimental
Arm Description
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.
Arm Title
Control with standard care
Arm Type
No Intervention
Arm Description
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. .
Intervention Type
Diagnostic Test
Intervention Name(s)
Video call
Intervention Description
The on-call neurologist can see and communicate with the patient via live stream video-call.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Rate of patients included in the trial amongst all patients screened
Time Frame
Through study completion, approximately 2 months
Title
Exclusion rate
Description
rate of patients excluded from participation amongst all patients screened
Time Frame
Through study completion, approximately 2 months
Title
Attrition rate
Description
rate of patients and data lost
Time Frame
Through study completion, approximately 5 months
Title
Adherence to protocol by the Emergency Medical Services
Description
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)
Title
Adherence to protocol by the neurologist prehospital
Description
Evaluation of missing data in the clinical examination conducted with video
Time Frame
Baseline (Prehospital examination of patient conducted on video by neurologists)
Title
Adherence to protocol by the neurologist intrahospital
Description
Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist
Time Frame
At admission
Title
Stakeholder Feedback Survey
Description
Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability
Time Frame
immediately after the intervention
Title
Patient Feedback Survey
Description
Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability
Time Frame
Between the day after admission and 5 days after admission
Secondary Outcome Measure Information:
Title
Acute ischemic stroke with Large Vessel Occlusion on neuroimaging
Description
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
Title
Other large vessel Acute ischemic stroke
Description
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
Title
Other Acute ischemic stroke
Description
Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke
Time Frame
at admission
Title
Haemorrhagic stroke
Description
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
Title
Duration of examination on video-call
Description
Duration of examination on video-call measured in minutes
Time Frame
up to 60 minutes (prior to admission, prehospital phase)
Title
Mimic mistaken for stroke
Description
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
Title
Prehospital time on scene
Description
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)
Title
90 days modified Rankin Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trine Nielsen
Phone
+45 60218866
Email
trine.nielsen2@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Backer Mogensen
Organizational Affiliation
Hospital of Southern Denmark - Aabenraa
Official's Role
Study Director
Facility Information:
Facility Name
Sygehus Soenderjylland
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33252631
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.
Results Reference
background
PubMed Identifier
32250423
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.
Results Reference
background

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

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