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Virtual Intervention Stroke Initiative (VISION)

Primary Purpose

Ischemic Stroke, Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual assessment
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring telemedicine, virtual care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older admitted to the general internal medicine service of the Ottawa Hospital General Campus for acute ischemic stroke able to participate in video assessments with necessary accommodation/facilitation for participation (particularly if stroke results in physical or communication deficits) Exclusion Criteria: patients who are unable, in the judgement of the study team or treating team, to participate in video assessments

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Virtual assessment

    Arm Description

    virtual assessment with a stroke neurologist/advanced practice nurse, with interdisciplinary support, to facilitate the care of patients admitted to primary stroke centres using existing tools for remote evaluation and review.

    Outcomes

    Primary Outcome Measures

    Morbidity-adjusted length of stay
    Number of days admitted to general internal medicine

    Secondary Outcome Measures

    Length of time on ALC
    Length of time on alternate level of care

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    May 23, 2023
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    The Ottawa Hospital Academic Medical Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05875389
    Brief Title
    Virtual Intervention Stroke Initiative
    Acronym
    VISION
    Official Title
    Virtual Intervention Stroke Initiative by Ottawa Neurology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    The Ottawa Hospital Academic Medical Association

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to determine if patients admitted to a primary stroke centre, such as the general internal medicine service of the Ottawa Hospitals General Campus, for acute ischemic stroke would benefit from a scheduled virtual assessment with a stroke neurologist to review investigations, results, and evaluations to identify stroke etiology, propose appropriate therapy, and guide decision-making and multidisciplinary assessment, similar to services provided to patients admitted to comprehensive stroke centres, such as the Civic Campus of the Ottawa Hospital.
    Detailed Description
    Patients admitted to primary stroke centres do not have access to the same level of stroke expertise on site as do patients admitted to comprehensive stroke centres, resulting in increased length of stay with implications for access to stroke rehabilitation. Virtual access to stroke experts has been used in hyperacute stroke care through programs such as Ontario Telestroke, but this has not been routinely used for acute inpatient management. The investigators propose a system to provide virtual access to the stroke neurology team to patients admitted with stroke in a primary stroke centre. Patients at the General Campus of the Ottawa Hospital are currently admitted to Internal Medicine; this includes scheduled virtual assessment with a stroke neurologist and advanced practice nurse/interdisciplinary support to review investigations, results, and evaluations to identify stroke etiology, propose appropriate therapy, and guide decision-making and multidisciplinary assessment, similar to services provided to patients admitted to the Civic Campus. This will be developed with the assistance of Internal Medicine and will utilize technologies and assessment tools and strategies already being used for provision of virtual care in other settings. The goal of this project will be to prove that patients in primary stroke centres, with the assistance of virtual care, can benefit from the expertise available at comprehensive centers throughout their stay, and that this will result in an improved quality of care with benefits for patients, hospitals, and the community.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, Acute Ischemic Stroke
    Keywords
    telemedicine, virtual care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual assessment
    Arm Type
    Experimental
    Arm Description
    virtual assessment with a stroke neurologist/advanced practice nurse, with interdisciplinary support, to facilitate the care of patients admitted to primary stroke centres using existing tools for remote evaluation and review.
    Intervention Type
    Other
    Intervention Name(s)
    Virtual assessment
    Intervention Description
    virtual assessment with a stroke neurologist/advanced practice nurse, with interdisciplinary support, to facilitate the care of patients admitted to primary stroke centres using existing tools for remote evaluation and review.
    Primary Outcome Measure Information:
    Title
    Morbidity-adjusted length of stay
    Description
    Number of days admitted to general internal medicine
    Time Frame
    Through study completion, an average of 6 months
    Secondary Outcome Measure Information:
    Title
    Length of time on ALC
    Description
    Length of time on alternate level of care
    Time Frame
    Through study completion, an average of 6 months
    Other Pre-specified Outcome Measures:
    Title
    Discharge destination
    Description
    The classification of where a patient is sent on completion of their hospital admission (i.e. home vs. rehabilitation vs. other facility vs. death)
    Time Frame
    Over 6 months
    Title
    Functional outcome
    Description
    modified Rankin Score 0-6 (0 is no symptoms at all, and 6 is death)
    Time Frame
    Over 6 months
    Title
    Home time
    Description
    patient-centered metric examining time spent at home after discharge from hospital/rehabilitation at 6 months
    Time Frame
    Over 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older admitted to the general internal medicine service of the Ottawa Hospital General Campus for acute ischemic stroke able to participate in video assessments with necessary accommodation/facilitation for participation (particularly if stroke results in physical or communication deficits) Exclusion Criteria: patients who are unable, in the judgement of the study team or treating team, to participate in video assessments

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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