Back to resultsEvaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
Primary Purpose
Ischemic Stroke, Intracerebral Hemorrhage
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Telemedicine Assessment by Remote Neurologist
In-Person Assessment by an Onboard Neurologist
Sponsored by
About this trial
This is an interventional health services research trial for Ischemic Stroke focused on measuring mobile stroke unit, stroke
Eligibility Criteria
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.
Sites / Locations
- Royal Melbourne Hospital Mobile Stroke UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine Assessment by Remote Neurologist
In-Person Assessment by an Onboard Neurologist
Arm 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.
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.
Outcomes
Primary Outcome Measures
Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency
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)
On-scene to imaging
On-scene to imaging review by the neurologist
On-scene to definitive decision making
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
Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05991310
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Intracerebral Hemorrhage
Keywords
mobile stroke unit, stroke
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Assessment by Remote Neurologist
Arm Type
Experimental
Arm 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.
Arm Title
In-Person Assessment by an Onboard Neurologist
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Telemedicine Assessment by Remote Neurologist
Intervention Description
Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.
Intervention Type
Other
Intervention Name(s)
In-Person Assessment by an Onboard Neurologist
Intervention Description
Traditional in-person assessment of a patient by a neurologist located onboard the MSU
Primary Outcome Measure Information:
Title
Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency
Description
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.
Time Frame
See pre-specified outcome section for details
Secondary Outcome Measure Information:
Title
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)
Title
On-scene to imaging
Time Frame
Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Title
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)
Title
On-scene to definitive decision making
Description
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)
Time Frame
Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Title
90-Day mRS
Description
Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval
Time Frame
90 days (+/- 10 days from symptom onset)
Other Pre-specified Outcome Measures:
Title
Safety Outcomes
Description
Clinician unable to complete assessment
Post-thrombolysis Complications
Deterioration during assessment
Time Frame
Up to 72 hours from symptom onset
Title
Scene-to-decision Treatment Times
Time Frame
Up to 2 hours from arrival on-scene
Title
Resource Efficiency
Description
Evaluated as the proportion of productive time the neurologist is actively involved in the care of the patient
Time Frame
Up to 12 hours (duration of MSU working hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Parsons
Phone
0393427000
Email
nicola.parsons@mh.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vignan Yogendrakumar, MD MSc
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna H Balabanski, MD PhD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Melbourne Hospital Mobile Stroke Unit
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Parsons
Email
nicola.parsons@mh.org.au
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
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