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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes |
| Up to 72 hours from symptom onset |
| Scene-to-decision Treatment Times |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vignan Yogendrakumar, MD PhD | Melbourne Health | Principal Investigator |
| Anna H Balabanski, MD PhD | Melbourne Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Melbourne Hospital Mobile Stroke Unit | Melbourne | Victoria | 3050 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39424402 | Background | 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. | |
| 41429047 |
| Label | URL |
|---|---|
| Statistical Analysis Plan | View source |
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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.
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| In-Person Assessment by an Onboard Neurologist | Other | Traditional in-person assessment of a patient by a neurologist located onboard the MSU |
|
| 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 | 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) |
| 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 | Up to 12 hours (duration of MSU working hours) |
| Derived |
| 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. 2026 Feb;5(2):EVIDoa2500217. doi: 10.1056/EVIDoa2500217. Epub 2025 Dec 22. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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