Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
Noninvasive prospective multi-center study of an interactive 2-way, wireless or
 site-independent, audiovisual telemedicine system designed for real-time remote examination
 of acute stroke symptoms and deficits as a basis for treatment consultation and
 recommendation.

 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.

 60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner
 discretion (onset generally less than 12 hours and likely less than 3 hours)

 Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only
 (Control n = 30)
Design

 Noninvasive prospective multi-center study of an interactive 2-way, wireless or
 site-independent, audiovisual telemedicine system designed for real-time remote examination
 of acute stroke symptoms and deficits as a basis for treatment consultation and
 recommendation.

 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.

 60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner
 discretion (onset generally less than 12 hours and likely less than 3 hours)

 Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only
 (Control n = 30)

 Assessments

 All cases will undergo the following assessments:

 Patient-Level Visits

 Baseline: Pre-stroke Modified Rankin Scale (demographics), pre-treatment Modified Rankin
 Scale, medications during prior 3 days, physical exam and vital signs, NIHSS, Modified NIHSS,
 EKG, screening labs, and head CT scan

 Treatment: Treatment times, thrombolytic safety outcome, and recanalization treatment

 Day 90: Modified Rankin Scale, Barthel Index, and mortality

 End of Study: End of study/Termination

 Meta-Level Reviews

 Adjudication: Post case completion, review and evaluation of each remote consultation on
 whether the recommendation for or against thrombolytic therapy was appropriate, given the
 information presented at each of 3 levels of adjudication.

 Central Read: Post case completion, review and evaluation of each Baseline head CT scan
 interpretation on whether there was a CT contraindication to thrombolytic therapy.

 Trial Groups

 There will be two trial groups in this study. The investigators hypothesized (based upon
 sample size calculations) that the correct treatment will be recommended at rates of 80%
 (telephone) and 90% (full telemedicine).

 Target Population

 60 AZ patients will be randomized to either telephone-only or video telemedicine
 consultation. Appropriateness of therapeutic decision-making, numbers treated, time to
 treatment, and completeness of data collection will be evaluated and compared for each group.

 If the protocol or grant application is investigator-initiated, a 200-word (or less) abstract
 of the proposed protocol or grant application must be included (an abstract included in an
 NIH or other submission is acceptable). If the protocol is sponsor initiated, a summary
 written by the Mayo investigator must be included. Summary should include: 1) Hypothesis, 2)
 Basic study plan, 3) Statistical method/rationale, 4) Scientific basis or justification, 5)
 Inclusion/exclusion criteria, and 6) Monetary consideration. You may type or cut and paste
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 Objectives

 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.
Subject Inclusion Criteria

 For inclusion in the study, subjects must fulfill all of the following criteria:

 -  Written Informed Consent

 -  Eighteen 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)

 Subject Exclusion Criteria

 The following is the sole criterion for exclusion from the study:

 -  Unlikely to complete study through 90-day follow-up