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

Not Applicable

Active, not recruiting

• Conditions: Intracerebral Hemorrhage; Ischemic Stroke

• Registration Number: NCT05991310
• Lead Sponsor: Melbourne Health

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.

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-14
• Study Start: 2023-08-21
• Primary Completion: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 review by 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)
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 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)

Trial Locations

Locations (1)

Royal Melbourne Hospital Mobile Stroke Unit; 🇦🇺 Melbourne, Victoria, Australia