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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991310
• Other study ID #: 2023.110
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Melbourne Health
• Contact: Nicola Parsons
• Phone: 0393427000
• Email: nicola.parsons[@]mh.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Stroke

Intervention

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.
• In-Person Assessment by an Onboard Neurologist
Traditional in-person assessment of a patient by a neurologist located onboard the MSU

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital Mobile Stroke Unit	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcomes	Clinician unable to complete assessment; Post-thrombolysis Complications; Deterioration during assessment	Up to 72 hours from symptom onset
Other	Scene-to-decision Treatment Times		Up to 2 hours from arrival on-scene
Other	Resource Efficiency	Evaluated as the proportion of productive time the neurologist is actively involved in the care of the patient	Up to 12 hours (duration of MSU working hours)
Primary	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.	See pre-specified outcome section for details
Secondary	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)
Secondary	On-scene to imaging		Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Secondary	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)
Secondary	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)	Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
Secondary	90-Day mRS	Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval	90 days (+/- 10 days from symptom onset)