- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04951518
VAN Assessment Tool in the Treatment of Acute Ischemic Stroke
VAN - Training of Emergency Medical Services to Improve Stroke Outcomes in Northwest Arkansas
Study Overview
Detailed Description
The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study.
The investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- Washington Regional Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac
Exclusion Criteria:
- Stroke patients who arrive directly to the hospital (without the use of EMS services)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Van Positive
Large Vessel Occlusion Positive
|
V.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients
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Van Negative
Large Vessel Occlusion Negative
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V.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of VAN Assessment Tool
Time Frame: 1 Year
|
To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eligibility for Thrombolysis
Time Frame: 1 Year
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To investigate effect of the VAN tool to predict persons eligible for thrombolysis
|
1 Year
|
Eligibility for Thrombectomy
Time Frame: 1 Year
|
To investigate effect of the VAN tool to predict persons eligible for thrombectomy
|
1 Year
|
Door to Intervention Time
Time Frame: 1 Year
|
To investigate the effect of prehospital notification of VAN positive status vs routine notification on time door to needle or door to thrombectomy time
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1 Year
|
Modified Rankin Score
Time Frame: 1 Year
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To compare the discharge disposition and Rankin score of patients post intervention with VAN prenotification vs routine notification.
Rankin scores ranging from 0 - 5, with 0 being fully functioning and independent, and 5 being severe disability requiring constant nursing care.
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1 Year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V-109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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