Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit (MSU-TELEMED)

Melbourne Health

Status: Active, not recruiting

Conditions: Ischemic Stroke; Intracerebral Hemorrhage

Treatments: Other: In-Person Assessment by an Onboard Neurologist; Other: Telemedicine Assessment by Remote Neurologist

Study type: Interventional

Funder types: Other

Identifiers

NCT05991310

2023.110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Telemedicine Assessment by Remote Neurologist

Experimental group

Description:

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.

Treatment:

Other: Telemedicine Assessment by Remote Neurologist

In-Person Assessment by an Onboard Neurologist

Active Comparator group

Description:

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.

Treatment:

Other: In-Person Assessment by an Onboard Neurologist