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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
270
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
Royal Melbourne Hospital Mobile Stroke Unit
Melbourne, Victoria, Australia
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)