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

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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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-08-21

Primary completion: 2024-09-01

Study completion finish: 2024-09-01

Study type

HEALTH_SERVICES_RESEARCH

Phase

Trial ID

NCT05991310

Intervention or treatment

OTHER: Telemedicine Assessment by Remote Neurologist

OTHER: In-Person Assessment by an Onboard Neurologist

Conditions

• Ischemic Stroke
• Intracerebral Hemorrhage

Condition: Ischemic Stroke, Intracerebral Hemorrhage
OTHER: Telemedicine Assessment by Remote Neurologist and other drugs
Melbourne, Victoria, Australia
Sponsor: Melbourne Health

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Find a site

Closest Location:

Royal Melbourne Hospital Mobile Stroke Unit

Research sites nearby

Select from list below to view details:

Royal Melbourne Hospital Mobile Stroke Unit
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Telemedicine Assessment by Remote Neurologist 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 Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.
ACTIVE_COMPARATOR: In-Person Assessment by an Onboard Neurologist 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 Traditional in-person assessment of a patient by a neurologist located onboard the MSU

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Telemedicine Assessment by Remote Neurologist

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

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

ACTIVE_COMPARATOR: In-Person Assessment by an Onboard Neurologist

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

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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
On-scene to eyes-on-patient (for the neurologist)	Not Specified	Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
On-scene to imaging	Not Specified	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	Not Specified	Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
On-scene to definitive decision making	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)	Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
90-Day mRS	Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval	90 days (+/- 10 days from symptom onset)

Frequently Asked Questions

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References

Clinical Trials Gov: Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit