Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit

NCT05991310 | Active Not Recruiting DMC

• 1 other identifier: 2023.110
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare a telemedicine neurologist staffing model to a traditional on-board model in patients being assessed for suspected acute stroke on a mobile stroke unit.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage

Keywords

mobile stroke unit; stroke

Outcome Measures

Primary Outcomes (1)

• Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency

  The odds that a random participant treated through a telemedicine assessment will have a more desirable DOOR scale outcome than a random participant treated by an onboard neurologist. Such a odds is referred to as the Win Ratio, as it reflects the odds of a random participant treated via telemedicine "winning" against a random participant treated via an onboard model in a direct one-to-one comparison. The design evaluates, in order of importance: Safety, Scene-to-decision time metrics, Resource efficiency If a participant in one treatment arm is achieving better safety than the comparator, this is defined as a "win" for that participant and a "loss" for the comparator. If there is no difference in safety, time to treatment decision is compared. If no clinically meaningful difference is observed, then resource utilization is compared. If there is no difference in resource utilization, the two participants are declared as tied for the overall outcome.

  See pre-specified outcome section for details

Secondary Outcomes (5)

• On-scene to eyes-on-patient (for the neurologist)

  Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)

• On-scene to imaging

  Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)

• On-scene to imaging review by the neurologist

  Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)

• On-scene to definitive decision making

  Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)

• 90-Day mRS

  90 days (+/- 10 days from symptom onset)

Other Outcomes (3)

• Safety Outcomes

  Up to 72 hours from symptom onset

• Scene-to-decision Treatment Times

  Up to 2 hours from arrival on-scene

• Resource Efficiency

  Up to 12 hours (duration of MSU working hours)

Study Arms (2)

Telemedicine Assessment by Remote Neurologist

EXPERIMENTAL

Following the initial assessment, the stroke nurse will activate the telemedicine video conference call and review the patient with the telemedicine neurologist. The telemedicine neurologist will perform a NIHSS with assistance from the stroke nurse, and this will be documented on the clinical records. Imaging will be evaluated remotely by the telemedicine neurologist. If there is a decision to administer thrombolysis, the stroke neurologist and nurse will discuss treatment with the patient or next of kin, where appropriate and able, to acquire assent in a timely manner.

Other: Telemedicine Assessment by Remote Neurologist

In-Person Assessment by an Onboard Neurologist

ACTIVE COMPARATOR

Upon arrival on-scene, the MSU stroke nurse, neurologist, and paramedic will liaise with local ambulance services to obtain initial clinical details and perform an initial assessment. The NIHSS will be performed by the neurologist, and this will be documented on standardized clinical records. Imaging will be assessed at the console available within the ambulance. If there is a decision to administer thrombolysis, the stroke neurologist and nurse will discuss treatment with the patient or next of kin, where appropriate and able, to acquire assent in a timely manner.

Other: In-Person Assessment by an Onboard Neurologist

Interventions

Telemedicine Assessment by Remote Neurologist OTHER

Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.

Telemedicine Assessment by Remote Neurologist

In-Person Assessment by an Onboard Neurologist OTHER

Traditional in-person assessment of a patient by a neurologist located onboard the MSU

In-Person Assessment by an Onboard Neurologist

Eligibility Criteria

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

You may qualify if:

• Adults \>=18 years of age
• Presenting within 24 hours of symptom onset or last known well.
• Patients assessed by MSU without cancellation (either by the local ambulance team or by MSU) prior to attending the patient.

You may not qualify if:

• Attendance of the Melbourne MSU is deemed unnecessary by either the local paramedic team or the MSU team based on provided information prior to arrival on scene.
• The patient presents significant medical or logistical challenges which greatly delay standard treatment.
• Any other medical contraindication at the discretion of the investigator.

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (1)

Royal Melbourne Hospital Mobile Stroke Unit

Melbourne, Victoria, 3050, Australia

Location

Related Publications (2)

• Yogendrakumar V, Balabanski AH, Johns H, Churilov L, Parsons NK, Beharry J, Weir L, Yassi N, Zhao H, Warwick A, Coote S, Langenberg F, Branagan L, Siddiqi W, Bivard A, Campbell BCV, Donnan GA, Davis SM; MSU-TELEMED Investigators dagger. Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open-Label Blinded End-Point Randomized Controlled Trial. J Am Heart Assoc. 2024 Nov 5;13(21):e036856. doi: 10.1161/JAHA.124.036856. Epub 2024 Oct 18.

  PMID: 39424402 BACKGROUND

• Yogendrakumar V, Balabanski AH, Johns H, Churilov L, Mutimer CA, Barker J, Parsons NK, Shin SJ, Beharry J, Weir L, Yassi N, Zhao H, Warwick A, Coote S, Langenberg F, Branagan L, Siddiqi W, Hocking G, Ng FC, Sanders LM, Choi PMC, Wijeratne T, Crompton DE, Ma H, Cloud G, Campbell BCV, Donnan GA, Davis SM. A Randomized Trial of Telemedicine Models of Care on a Mobile Stroke Unit. NEJM Evid. 2025 Dec 22:EVIDoa2500217. doi: 10.1056/EVIDoa2500217. Online ahead of print.

  PMID: 41429047 DERIVED

Related Links

• Statistical Analysis Plan

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vignan Yogendrakumar, MD PhD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

• Anna H Balabanski, MD PhD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The days in which the neurologist will be on or off the mobile stroke unit will be randomly determined. Randomization will be stratified by nurse category (Nurse Practitioner versus Clinical Nurse Consultant) with an adaptive component to balance the number of patients reviewed in person or via telemedicine within each nurse category. The randomized schedule will be generated in a rolling fashion on a weekly basis.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: August 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

AU (1)