Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera

Study Overview
=================
Brief Summary
-----------------
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)

Detailed Description
-----------------
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 from an existing document to address this question Objectives 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; and to assess the completeness of the data collection in telemedicine versus telephone-only consultations.

Official Title
-----------------
Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Other: Telephone
* Other: Two way audio/video telemedicine consult


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Acute Stroke Telephone consult for the decision of tPA within 3 hours of symptoms onset. | Other: Telephone<br>* Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.<br>|
| Active Comparator: 2<br>Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset. | Other: Two way audio/video telemedicine consult<br>* Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 90 days | 
| to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only |  | 90 days | 
| to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations |  | 90 days | 
| to assess the completeness of the data collection in telemedicine versus telephone-only consultations. |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Stroke, Acute, Rural, Thrombolysis, Consultation