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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05991310




Registration number
NCT05991310
Ethics application status
Date submitted
27/07/2023
Date registered
14/08/2023
Date last updated
21/09/2023

Titles & IDs
Public title
Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
Scientific title
Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit
Secondary ID [1] 0 0
2023.110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Intracerebral Hemorrhage 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Telemedicine Assessment by Remote Neurologist
Other interventions - In-Person Assessment by an Onboard Neurologist

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.

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 interventions: 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.

Other interventions: In-Person Assessment by an Onboard Neurologist
Traditional in-person assessment of a patient by a neurologist located onboard the MSU
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency
Timepoint [1] 0 0
See pre-specified outcome section for details
Secondary outcome [1] 0 0
On-scene to eyes-on-patient (for the neurologist)
Timepoint [1] 0 0
Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Secondary outcome [2] 0 0
On-scene to imaging
Timepoint [2] 0 0
Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Secondary outcome [3] 0 0
On-scene to imaging review by the neurologist
Timepoint [3] 0 0
Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Secondary outcome [4] 0 0
On-scene to definitive decision making
Timepoint [4] 0 0
Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Secondary outcome [5] 0 0
90-Day mRS
Timepoint [5] 0 0
90 days (+/- 10 days from symptom onset)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital Mobile Stroke Unit - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05991310
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vignan Yogendrakumar, MD MSc
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicola Parsons
Address 0 0
Country 0 0
Phone 0 0
0393427000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05991310