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NCT Number: NCT05991310

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Melbourne Hospital Mobile Stroke Unit

Melbourne, Victoria, 3050, Australia

About this study

This study is a prospective randomized mobile stroke unit trial comparing two staffing models: 1) a neurologist reviewing the patient via telemedicine (intervention) versus 2) an onboard neurologist assessing the patient in-person (comparator). Daily periods of remote (telemedicine) or in person (onboard) neurologist assessments will be randomly determined using an adaptive design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

In-Person Assessment by an Onboard Neurologist

Other

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

Primary outcomes

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

    Time frame: See pre-specified outcome section for details

    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.

Secondary outcomes

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

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

  2. On-scene to imaging

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

  3. On-scene to imaging review by the neurologist

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

  4. On-scene to definitive decision making

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

    Inclusive of the following: 1) Decision for thrombolysis, 2) Decision to refer for endovascular thrombectomy, 3) Decision to stand down case, or 4) Decision to transfer to stroke hospital (e.g. suspected stroke but unable to treat on MSU)

  5. 90-Day mRS

    Time frame: 90 days (+/- 10 days from symptom onset)

    Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval

Other outcomes

  1. Safety Outcomes

    Time frame: Up to 72 hours from symptom onset

    • Clinician unable to complete assessment
    • Post-thrombolysis Complications
    • Deterioration during assessment

  2. Scene-to-decision Treatment Times

    Time frame: Up to 2 hours from arrival on-scene

  3. Resource Efficiency

    Time frame: Up to 12 hours (duration of MSU working hours)

    Evaluated as the proportion of productive time the neurologist is actively involved in the care of the patient

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Registry information

Acronym: MSU-TELEMED

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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