Intracerebral Hemorrhage, Ischemic Stroke
Conditions
Keywords
mobile stroke unit, stroke
Brief summary
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.
Detailed description
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.
Interventions
OTHERTelemedicine 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.
OTHERIn-Person Assessment by an Onboard Neurologist
Traditional in-person assessment of a patient by a neurologist located onboard the MSU
Sponsors
Melbourne Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults \>=18 years of age 2. Presenting within 24 hours of symptom onset or last known well. 3. Patients assessed by MSU without cancellation (either by the local ambulance team or by MSU) prior to attending the patient.
Exclusion criteria
1. 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. 2. The patient presents significant medical or logistical challenges which greatly delay standard treatment. 3. Any other medical contraindication at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency | 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
| Measure | Time frame | Description |
|---|---|---|
| On-scene to imaging | 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 of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene) | — |
| On-scene to definitive decision making | 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) |
| 90-Day mRS | 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 |
| 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) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resource Efficiency | 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 |
| Scene-to-decision Treatment Times | Up to 2 hours from arrival on-scene | — |
| Safety Outcomes | Up to 72 hours from symptom onset | 1. Clinician unable to complete assessment 2. Post-thrombolysis Complications 3. Deterioration during assessment |
Countries
Australia
Outcome results
None listed