Stroke
Conditions
Keywords
stroke, digital video, SPOTRIAS
Brief summary
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
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.
Interventions
None listed
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appropriateness of Decision to Treat or Not Treat With Thrombolytics | potentially within 3 hours of symptom onset | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Intracerebral Hemorrhage (ICH) | 36 hours | 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. |
| Percentage of Total Thrombolytic Administrations | potentially within 3 hours of symptom onset | 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. |
| Time to Treatment Decision for Administration of Thrombolytics | potentially within 3 hours of symptom onset | time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation. |
| Percentage of Evaluations With Technical Observations | Time of consultation | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment completed in 4/07
Pre-assignment details
There were 11 initial run-in patients used to validate the system but these patients were excluded from the final analysis. There was also 1 patient removed from analysis because of a protocol violation (age \< 18) so this patient was excluded rom any analysis (Initial patients=234. 11 Run in=223. 1 removed=222. This accounts for final numbers)
Participants by arm
| Arm | Count |
|---|---|
| Telemedicine Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine | 111 |
| Telephone Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM | 111 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 8 |
Baseline characteristics
| Characteristic | Telephone | Telemedicine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 75 Participants | 73 Participants | 148.0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 38 Participants | 74.0 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 14.9 | 70.4 years STANDARD_DEVIATION 14.5 | 69.7 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 111 participants | 111 participants | 222.0 participants |
| Sex: Female, Male Female | 57 Participants | 57 Participants | 114.0 Participants |
| Sex: Female, Male Male | 54 Participants | 54 Participants | 108.0 Participants |
Outcome results
Primary
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.
Time frame: potentially within 3 hours of symptom onset
Population: Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Appropriateness of Decision to Treat or Not Treat With Thrombolytics | 98 percentage of participants |
| Telephone | Appropriateness of Decision to Treat or Not Treat With Thrombolytics | 82 percentage of participants |
Secondary
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 frame: Time of consultation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Percentage of Evaluations With Technical Observations | 0 Percentage of Evaluations |
| Telephone | Percentage of Evaluations With Technical Observations | 12 Percentage of Evaluations |
Secondary
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.
Time frame: 36 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Percentage of Participants With Intracerebral Hemorrhage (ICH) | 7 Percentage of participants |
| Telephone | Percentage of Participants With Intracerebral Hemorrhage (ICH) | 8 Percentage of participants |
Secondary
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.
Time frame: potentially within 3 hours of symptom onset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine | Percentage of Total Thrombolytic Administrations | 28 Percentage of participants |
| Telephone | Percentage of Total Thrombolytic Administrations | 23 Percentage of participants |
Secondary
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.
Time frame: potentially within 3 hours of symptom onset
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine | Time to Treatment Decision for Administration of Thrombolytics | 32 Minutes | Standard Deviation 17 |
| Telephone | Time to Treatment Decision for Administration of Thrombolytics | 23 Minutes | Standard Deviation 24 |