xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991310</url>
    </required_header>
    <id_info>
      <org_study_id>2023.110</org_study_id>
      <nct_id>NCT05991310</nct_id>
    </id_info>
    <brief_title>Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit</brief_title>
    <official_title>Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Melbourne Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Melbourne Health</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare a telemedicine neurologist staffing model to a&#xD;
        traditional on-board model in patients being assessed for suspected acute stroke on a mobile&#xD;
        stroke unit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective randomized mobile stroke unit trial comparing two staffing&#xD;
        models: 1) a neurologist reviewing the patient via telemedicine (intervention) versus 2) an&#xD;
        onboard neurologist assessing the patient in-person (comparator). Daily periods of remote&#xD;
        (telemedicine) or in person (onboard) neurologist assessments will be randomly determined&#xD;
        using an adaptive design.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency</measure>
      <time_frame>See pre-specified outcome section for details</time_frame>
      <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 &quot;winning&quot; against a random participant treated via an onboard model in a direct one-to-one comparison.&#xD;
  The design evaluates, in order of importance: Safety, Scene-to-decision time metrics, Resource efficiency&#xD;
  If a participant in one treatment arm is achieving better safety than the comparator, this is defined as a &quot;win&quot; for that participant and a &quot;loss&quot; 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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>On-scene to eyes-on-patient (for the neurologist)</measure>
      <time_frame>Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>On-scene to imaging</measure>
      <time_frame>Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>On-scene to imaging review by the neurologist</measure>
      <time_frame>Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>On-scene to definitive decision making</measure>
      <time_frame>Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>90-Day mRS</measure>
      <time_frame>90 days (+/- 10 days from symptom onset)</time_frame>
      <description>Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Safety Outcomes</measure>
      <time_frame>Up to 72 hours from symptom onset</time_frame>
      <description>Clinician unable to complete assessment&#xD;
  Post-thrombolysis Complications&#xD;
  Deterioration during assessment</description>
    </other_outcome>
    <other_outcome>
      <measure>Scene-to-decision Treatment Times</measure>
      <time_frame>Up to 2 hours from arrival on-scene</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Resource Efficiency</measure>
      <time_frame>Up to 12 hours (duration of MSU working hours)</time_frame>
      <description>Evaluated as the proportion of productive time the neurologist is actively involved in the care of the patient</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">270</enrollment>
    <condition>Ischemic Stroke</condition>
    <condition>Intracerebral Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Telemedicine Assessment by Remote Neurologist</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>In-Person Assessment by an Onboard Neurologist</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telemedicine Assessment by Remote Neurologist</intervention_name>
      <description>Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.</description>
      <arm_group_label>Telemedicine Assessment by Remote Neurologist</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>In-Person Assessment by an Onboard Neurologist</intervention_name>
      <description>Traditional in-person assessment of a patient by a neurologist located onboard the MSU</description>
      <arm_group_label>In-Person Assessment by an Onboard Neurologist</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults &gt;=18 years of age&#xD;
  &#xD;
            2. Presenting within 24 hours of symptom onset or last known well.&#xD;
  &#xD;
            3. Patients assessed by MSU without cancellation (either by the local ambulance team or&#xD;
               by MSU) prior to attending the patient.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Attendance of the Melbourne MSU is deemed unnecessary by either the local paramedic&#xD;
               team or the MSU team based on provided information prior to arrival on scene.&#xD;
  &#xD;
            2. The patient presents significant medical or logistical challenges which greatly delay&#xD;
               standard treatment.&#xD;
  &#xD;
            3. Any other medical contraindication at the discretion of the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vignan Yogendrakumar, MD MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Melbourne Health</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anna H Balabanski, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Melbourne Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nicola Parsons</last_name>
      <phone>0393427000</phone>
      <email>nicola.parsons@mh.org.au</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mobile stroke unit</keyword>
    <keyword>stroke</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Cerebral Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991310
  org study id: 2023.110
  nct id: NCT05991310
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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.
  primary purpose: Health Services Research
  masking: None (Open Label)
  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
  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.
  measure: 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)
  measure: On-scene to imaging
  time frame: Time of Acute Assessment on the Mobile Stroke Unit (up to 2 hours from arrival on scene)
  measure: 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)
  measure: 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)
  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)
  measure: 90-Day mRS
  time frame: 90 days (+/- 10 days from symptom onset)
  description: Clinical outcomes for patients who receive thrombolysis on the MSU or are transferred to a comprehensive center for endovascular clot retrieval
  measure: Safety Outcomes
  time frame: Up to 72 hours from symptom onset
  description: Clinician unable to complete assessment
  Post-thrombolysis Complications
  Deterioration during assessment
  measure: Scene-to-decision Treatment Times
  time frame: Up to 2 hours from arrival on-scene
  measure: Resource Efficiency
  time frame: Up to 12 hours (duration of MSU working hours)
  description: Evaluated as the proportion of productive time the neurologist is actively involved in the care of the patient
  arm group label: Telemedicine Assessment by Remote Neurologist
  arm group type: Experimental
  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 group label: In-Person Assessment by an Onboard Neurologist
  arm group type: Active Comparator
  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: Telemedicine Assessment by Remote Neurologist
  description: Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.
  arm group label: Telemedicine Assessment by Remote Neurologist
  intervention type: Other
  intervention name: In-Person Assessment by an Onboard Neurologist
  description: Traditional in-person assessment of a patient by a neurologist located onboard the MSU
  arm group label: In-Person Assessment by an Onboard Neurologist
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vignan Yogendrakumar, MD MSc
  role: Principal Investigator
  affiliation: Melbourne Health
  last name: Anna H Balabanski, MD PhD
  role: Principal Investigator
  affiliation: Melbourne Health
  last name: Nicola Parsons
  phone: 0393427000
  email: nicola.parsons@mh.org.au
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Hemorrhage
  mesh term: Hemorrhage