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

Sponsor

Melbourne Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05991310

Collaborator

(none)

270

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Intracerebral Hemorrhage	Other: Telemedicine Assessment by Remote Neurologist Other: In-Person Assessment by an Onboard Neurologist	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemedicine Assessment by Remote Neurologist 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.	Other: Telemedicine 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.
Active Comparator: In-Person Assessment by an Onboard Neurologist 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.	Other: In-Person Assessment by an Onboard Neurologist Traditional in-person assessment of a patient by a neurologist located onboard the MSU

Arm

Intervention/Treatment

Experimental: Telemedicine Assessment by Remote Neurologist

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.

Other: Telemedicine 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.

Active Comparator: In-Person Assessment by an Onboard Neurologist

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.

Other: In-Person Assessment by an Onboard Neurologist

Traditional in-person assessment of a patient by a neurologist located onboard the MSU

Outcome Measures

Primary Outcome Measures

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

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 [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

Other Outcome Measures

Safety Outcomes [Up to 72 hours from symptom onset]
Clinician unable to complete assessment Post-thrombolysis Complications Deterioration during assessment
Scene-to-decision Treatment Times [Up to 2 hours from arrival on-scene]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults >=18 years of age
Presenting within 24 hours of symptom onset or last known well.
Patients assessed by MSU without cancellation (either by the local ambulance team or by MSU) prior to attending the patient.

Exclusion Criteria:

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.
The patient presents significant medical or logistical challenges which greatly delay standard treatment.
Any other medical contraindication at the discretion of the investigator.