STRokE DOC Arizona TIME
Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona: The Initial Mayo Clinic
Experience
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Status:
This study has been completed. As of September 30, 2008, 78 patients have been screened for trial eligibility and 52 subjects have been
randomized (20 at Yuma Regional Medical Center and 32 at Kingman Regional Medical Center). Overall, 30% of all
randomized subjects received intravenous thrombolytics.
Purpose:
Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.
Interventions:
Digital Observation Camera
Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
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Telephone Consult
Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
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Year Started:
2007
Year Finished:
2009
Design:
Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
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.
Patient Involvement:
Patients with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)will be randomized to one of two arms. [Two arms: Video Camera/Telemedicine (Intervention n = 25) and No Video Camera/Telephone only (Control n = 25)]
Primary Outcome:
To determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only;
to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; to assess the completeness of the data collection in telemedicine versus telephone-only consultations.
Results:
A single randomized, blinded, prospective trial comparing telephone-only consultations to telemedicine consultations for acute stroke was selected and appraised. Correct acute stroke treatment decisions were made more often in the telemedicine group versus the telephone-only group (98% vs. 82%, [number needed to assess = 6]). Stroke telemedicine when compared with telephone-only consultations was more sensitive (100% vs. 58%), more specific (98% vs. 92%), had a more favorable positive likelihood ratio (LR: 41 vs. 7) and negative likelihood ratio (LR: 0 vs. 0.5), and had higher predictive values (positive predictive value 94% vs. 76%, and negative predictive value 100% vs. 84%) for the determination of thrombolysis eligibility. In conclusion, stroke telemedicine when compared with telephone-only consultations is an effective method to determine thrombolysis eligibility for acute stroke patients who do not have immediate access to a stroke neurologist.
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Source of Information:
ClinicalTrials.gov
Presented at the 2009 International Stroke Conference (February 2009).
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Web Links and Publications:
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This information last updated on: 10/26/2009
Reviewed on: 10/26/2009.
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Trials
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