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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05991310
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Melbourne Health

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Actual Study Start Date : August 21, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency [ Time Frame: 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 :
  1. On-scene to eyes-on-patient (for the neurologist) [ Time Frame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene) ]
  2. On-scene to imaging [ Time Frame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene) ]
  3. On-scene to imaging review by the neurologist [ Time Frame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene) ]
  4. On-scene to definitive decision making [ Time Frame: 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)

  5. 90-Day mRS [ Time Frame: 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:
  1. Safety Outcomes [ Time Frame: Up to 72 hours from symptom onset ]
    1. Clinician unable to complete assessment
    2. Post-thrombolysis Complications
    3. Deterioration during assessment

  2. Scene-to-decision Treatment Times [ Time Frame: Up to 2 hours from arrival on-scene ]
  3. Resource Efficiency [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05991310


Contacts
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Contact: Nicola Parsons 0393427000 nicola.parsons@mh.org.au

Locations
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Australia, Victoria
Royal Melbourne Hospital Mobile Stroke Unit Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Nicola Parsons       nicola.parsons@mh.org.au   
Sponsors and Collaborators
Melbourne Health
Investigators
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Principal Investigator: Vignan Yogendrakumar, MD MSc Melbourne Health
Principal Investigator: Anna H Balabanski, MD PhD Melbourne Health
More Information
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Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT05991310    
Other Study ID Numbers: 2023.110
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melbourne Health:
mobile stroke unit
stroke
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages