Clinical trial NCT05991310: Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
Official title: Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Intracerebral Hemorrhage
Keywords: mobile stroke unit
stroke
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency
timeFrame: See pre-specified outcome section for details
Secondary outcomes:
measure: On-scene to eyes-on-patient (for the neurologist)
timeFrame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
measure: On-scene to imaging
timeFrame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
measure: On-scene to imaging review by the neurologist
timeFrame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
measure: On-scene to definitive decision making
timeFrame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
measure: 90-Day mRS
timeFrame: 90 days (+/- 10 days from symptom onset)
Other outcomes:
measure: Safety Outcomes
timeFrame: Up to 72 hours from symptom onset
measure: Scene-to-decision Treatment Times
timeFrame: Up to 2 hours from arrival on-scene
measure: Resource Efficiency
timeFrame: Up to 12 hours (duration of MSU working hours)
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital Mobile Stroke Unit
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Vignan Yogendrakumar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Melbourne Health
name: Anna H Balabanski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.