Ischemic StrokeMSU-TELEMEDNCT05991310
Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
A study testing Telemedicine Assessment by Remote Neurologist and In-Person Assessment by an Onboard Neurologist in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Melbourne Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intracerebral Hemorrhage
- What is being tested?
- Telemedicine Assessment by Remote Neurologist and In-Person Assessment by an Onboard Neurologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Aug 2023to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Melbourne Hospital Mobile Stroke Unit
Melbourne, Victoria, 3050
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage
- Being tested
- Telemedicine Assessment by Remote Neurologist, In-Person Assessment by an Onboard Neurologist
- Keywords
- mobile stroke unit, stroke
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine Assessment by Remote NeurologistOther
Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.
In-Person Assessment by an Onboard NeurologistOther
Traditional in-person assessment of a patient by a neurologist located onboard the MSU
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Assessment by Remote Neurologist | Experimental | 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. Receives: Other: Telemedicine Assessment by Remote Neurologist |
| In-Person Assessment by an Onboard Neurologist | Active comparator | 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. Receives: Other: In-Person Assessment by an Onboard Neurologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: See pre-specified outcome section for details
Secondary outcomes (5)
On-scene to eyes-on-patient (for the neurologist)
Measured: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
On-scene to imaging
Measured: 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
Measured: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
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)
Measured: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
90-Day mRS
Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval
Measured: 90 days (+/- 10 days from symptom onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Aug 2023
- Primary completion1 Dec 2024
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vignan Yogendrakumar, MD PhD, Principal investigator, Melbourne HealthAnna H Balabanski, MD PhD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991310
- Sponsor's protocol ID
- 2023.110
- Acronym
- MSU-TELEMED
- Status last verified
- Feb 2025
- First submitted
- 27 Jul 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39424402Yogendrakumar V, Balabanski AH, Johns H, Churilov L, Mutimer CA, Barker J, Parsons NK, Shin SJ, Beharry J, Weir L, Yassi N, Zhao H, Warwick A, Coote S, Langenberg F, Branagan L, Siddiqi W, Hocking G, Ng FC, Sanders LM, Choi PMC, Wijeratne T, Crompton DE, Ma H, Cloud G, Campbell BCV, Donnan GA, Davis SM. A Randomized Trial of Telemedicine Models of Care on a Mobile Stroke Unit. NEJM Evid. 2026 Feb;5(2):EVIDoa2500217. doi: 10.1056/EVIDoa2500217. Epub 2025 Dec 22.
PubMed 41429047
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
- ClinicalTrials.gov ID
- NCT05991310
- Acronym / sponsor ID
- MSU-TELEMED / 2023.110
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage
- Keywords
- mobile stroke unit, stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Assessment by Remote Neurologist | Experimental | Other: Telemedicine Assessment by Remote NeurologistFollowing 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. |
| In-Person Assessment by an Onboard Neurologist | Active comparator | Other: In-Person Assessment by an Onboard NeurologistUpon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Assessment by Remote NeurologistUse of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments. | Other | Telemedicine Assessment by Remote Neurologist |
| In-Person Assessment by an Onboard NeurologistTraditional in-person assessment of a patient by a neurologist located onboard the MSU | Other | In-Person Assessment by an Onboard Neurologist |
Primary outcome
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.
5 secondary outcomes
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)
On-scene to imaging
Time frame: 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 frame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
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)
90-Day mRS
Time frame: 90 days (+/- 10 days from symptom onset)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 39424402Yogendrakumar 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.
- Derived from this study: PubMed 41429047Yogendrakumar V, Balabanski AH, Johns H, Churilov L, Mutimer CA, Barker J, Parsons NK, Shin SJ, Beharry J, Weir L, Yassi N, Zhao H, Warwick A, Coote S, Langenberg F, Branagan L, Siddiqi W, Hocking G, Ng FC, Sanders LM, Choi PMC, Wijeratne T, Crompton DE, Ma H, Cloud G, Campbell BCV, Donnan GA, Davis SM. A Randomized Trial of Telemedicine Models of Care on a Mobile Stroke Unit. NEJM Evid. 2026 Feb;5(2):EVIDoa2500217. doi: 10.1056/EVIDoa2500217. Epub 2025 Dec 22.
- Statistical Analysis PlanLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vignan Yogendrakumar, MD PhD principal investigator
Melbourne Health
Anna H Balabanski, MD PhD principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Assessment by Remote Neurologist and In-Person Assessment by an Onboard Neurologist in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency (time frame: See pre-specified outcome section for details). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.