Stroke Team Remote Evaluation Using a Digital Observation Camera

Study Overview
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Brief Summary
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The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.

Detailed Description
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The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) system is a digital video camera system that can transfer video and audio images from the clinic or emergency room to a distant (remote) place where a stroke specialist can review the images in real time (as they happen). This system uses site independent software to access the camera system from multiple locations. The study will determine if video consultation is superior to telephone consultation for remote evaluation or treatment of stroke patients, and the usefulness of this system in evaluating patients with suspected stroke symptoms. However, this method is being used in other fields of medicine for assistance in medical evaluations. Participants will be randomly assigned to receive evaluation by either the video camera system or by telephone alone. For those assigned to the video camera system, the system will be activated and will record and transmit video and audio images to a stroke specialist located at a remote location. He/she may ask the participants questions relating to medical illnesses and current symptoms, and may also review laboratory tests and x-ray images using a computer, if available. The stroke specialist will also perform general physical and neurological examinations, which will take place by video camera with the assistance of a bedside physician who will perform the actual examinations. For those participants assigned to the telephone-only consultation, the video system will not be activated, but the same procedure as above will be followed except the stroke specialist will not be able to see the participants or examine them using the video camera system. Participation in the study will last for the entire time the participants are in the hospital. Participants will be contacted by telephone by a study nurse 3 months post-stroke for a 10-minute interview regarding their current health. The total duration for individual participation is 3 months. The study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients.

Official Title
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A Prospective Study to Evaluate the Efficacy of a Remote Digital Observation Camera Protocol in the Evaluation and Thrombolytic Treatment of Acute Stroke Patients in the Remote Hospital Setting

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Symptoms consistent with acute stroke (ischemic or hemorrhagic) Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours) Exclusion Criteria: Unlikely to complete study through 90-day follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telemedicine<br>Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine | |
| Telephone<br>Patients randomized to this group were evaluated using telephone only and no use of the digital observation camera or DICOM | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of Decision to Treat or Not Treat With Thrombolytics | This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset. Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was appropriate to give or not give rt-PA. | potentially within 3 hours of symptom onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Intracerebral Hemorrhage (ICH) | Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage. | 36 hours | 
| Percentage of Total Thrombolytic Administrations | This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other. | potentially within 3 hours of symptom onset | 
| Time to Treatment Decision for Administration of Thrombolytics | time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation. | potentially within 3 hours of symptom onset | 
| Percentage of Evaluations With Technical Observations | Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial. | Time of consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital video, stroke, SPOTRIAS