An interventional study of Telemedicine Assessment by Remote Neurologist and In-Person Assessment by an Onboard Neurologist in Ischemic Stroke and Intracerebral Hemorrhage, sponsored by Melbourne Health. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Melbourne Health · Not applicable, Interventional, and Health services research
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 270 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.
Traditional in-person assessment of a patient by a neurologist located onboard the MSU
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.
Time frame: See pre-specified outcome section for details
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)
On-scene to imaging
Time frame: 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 frame: 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 frame: 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
Time frame: 90 days (+/- 10 days from symptom onset)
Safety Outcomes
1. Clinician unable to complete assessment 2. Post-thrombolysis Complications 3. Deterioration during assessment
Time frame: Up to 72 hours from symptom onset
Scene-to-decision Treatment Times
Time frame: Up to 2 hours from arrival on-scene
Resource Efficiency
Evaluated as the proportion of productive time the neurologist is actively involved in the care of the patient
Time frame: Up to 12 hours (duration of MSU working hours)
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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