Ischemic StrokeVISIONNCT05875389
Virtual Intervention Stroke Initiative
A study testing Virtual assessment in people with Ischemic Stroke and Acute Ischemic Stroke, run by Ottawa Hospital Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute Ischemic Stroke
- What is being tested?
- Virtual assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- patients who are unable, in the judgement of the study team or treating team, to participate in video assessments
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute Ischemic Stroke
- Being tested
- Virtual assessment
- Keywords
- telemedicine, virtual care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual assessment | Experimental | 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. Receives: Other: Virtual assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity-adjusted length of stay
Number of days admitted to general internal medicine
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
Length of time on ALC
Length of time on alternate level of care
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 May 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875389
- Sponsor's protocol ID
- 20230211-01H
- Acronym
- VISION
- Status last verified
- Apr 2024
- First submitted
- 9 May 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Intervention Stroke Initiative by Ottawa Neurology
- ClinicalTrials.gov ID
- NCT05875389
- Acronym / sponsor ID
- VISION / 20230211-01H
- Conditions
- Ischemic Stroke, Acute Ischemic Stroke
- Keywords
- telemedicine, virtual care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- 1 May 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual assessment | Experimental | Other: Virtual assessmentvirtual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- patients who are unable, in the judgement of the study team or treating team, to participate in video assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual assessmentvirtual 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. | Other | Virtual assessment |
Primary outcome
Morbidity-adjusted length of stay
Time frame: Through study completion, an average of 6 months
Number of days admitted to general internal medicine
1 secondary outcome
Length of time on ALC
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual assessment in people with Ischemic Stroke and Acute Ischemic Stroke, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity-adjusted length of stay (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.