- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875389
Virtual Intervention Stroke Initiative (VISION)
April 2, 2024 updated by: Ottawa Hospital Research Institute
Virtual Intervention Stroke Initiative by Ottawa Neurology
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual assessment
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity-adjusted length of stay
Time Frame: Through study completion, an average of 6 months
|
Number of days admitted to general internal medicine
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of time on ALC
Time Frame: Through study completion, an average of 6 months
|
Length of time on alternate level of care
|
Through study completion, an average of 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discharge destination
Time Frame: Over 6 months
|
The classification of where a patient is sent on completion of their hospital admission (i.e. home vs. rehabilitation vs. other facility vs. death)
|
Over 6 months
|
Functional outcome
Time Frame: Over 6 months
|
modified Rankin Score 0-6 (0 is no symptoms at all, and 6 is death)
|
Over 6 months
|
Home time
Time Frame: Over 6 months
|
patient-centered metric examining time spent at home after discharge from hospital/rehabilitation at 6 months
|
Over 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
May 23, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230211-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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