Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
Primary Purpose
Stroke, Acute
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone
Two way audio/video telemedicine consult
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring Telemedicine, Stroke, Acute, Rural, Thrombolysis, Consultation
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Acute Stroke Telephone consult for the decision of tPA within 3 hours of symptoms onset.
Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00623350
First Posted
February 15, 2008
Last Updated
May 11, 2011
Sponsor
Mayo Clinic
Collaborators
Arizona Department of Health Services, Yuma Regional Medical Center, Kingman Regional Medical Center, University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00623350
Brief Title
Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
Official Title
Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Arizona Department of Health Services, Yuma Regional Medical Center, Kingman Regional Medical Center, University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Telemedicine, Stroke, Acute, Rural, Thrombolysis, Consultation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Acute Stroke Telephone consult for the decision of tPA within 3 hours of symptoms onset.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
Intervention Type
Other
Intervention Name(s)
Telephone
Intervention Description
Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
Intervention Type
Other
Intervention Name(s)
Two way audio/video telemedicine consult
Intervention Description
Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
Primary Outcome Measure Information:
Title
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
Time Frame
90 days
Title
to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only
Time Frame
90 days
Title
to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations
Time Frame
90 days
Title
to assess the completeness of the data collection in telemedicine versus telephone-only consultations.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20431081
Citation
Demaerschalk BM, Bobrow BJ, Raman R, Kiernan TE, Aguilar MI, Ingall TJ, Dodick DW, Ward MP, Richemont PC, Brazdys K, Koch TC, Miley ML, Hoffman Snyder CR, Corday DA, Meyer BC; STRokE DOC AZ TIME Investigators. Stroke team remote evaluation using a digital observation camera in Arizona: the initial mayo clinic experience trial. Stroke. 2010 Jun;41(6):1251-8. doi: 10.1161/STROKEAHA.109.574509. Epub 2010 Apr 29.
Results Reference
result
PubMed Identifier
22984007
Citation
Demaerschalk BM, Bobrow BJ, Raman R, Ernstrom K, Hoxworth JM, Patel AC, Kiernan TE, Aguilar MI, Ingall TJ, Dodick DW, Meyer BC; Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) in Arizona-The Initial Mayo Clinic Experience (AZ TIME) Investigators. CT interpretation in a telestroke network: agreement among a spoke radiologist, hub vascular neurologist, and hub neuroradiologist. Stroke. 2012 Nov;43(11):3095-7. doi: 10.1161/STROKEAHA.112.666255. Epub 2012 Sep 13.
Results Reference
derived
PubMed Identifier
22400970
Citation
Demaerschalk BM, Raman R, Ernstrom K, Meyer BC. Efficacy of telemedicine for stroke: pooled analysis of the Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) and STRokE DOC Arizona telestroke trials. Telemed J E Health. 2012 Apr;18(3):230-7. doi: 10.1089/tmj.2011.0116. Epub 2012 Mar 8.
Results Reference
derived
PubMed Identifier
19694588
Citation
Miley ML, Demaerschalk BM, Olmstead NL, Kiernan TE, Corday DA, Chikani V, Bobrow BJ. The state of emergency stroke resources and care in rural Arizona: a platform for telemedicine. Telemed J E Health. 2009 Sep;15(7):691-9. doi: 10.1089/tmj.2009.0018.
Results Reference
derived
PubMed Identifier
19430275
Citation
Capampangan DJ, Wellik KE, Bobrow BJ, Aguilar MI, Ingall TJ, Kiernan TE, Wingerchuk DM, Demaerschalk BM. Telemedicine versus telephone for remote emergency stroke consultations: a critically appraised topic. Neurologist. 2009 May;15(3):163-6. doi: 10.1097/NRL.0b013e3181a4b79c.
Results Reference
derived
PubMed Identifier
19121244
Citation
Demaerschalk BM, Miley ML, Kiernan TE, Bobrow BJ, Corday DA, Wellik KE, Aguilar MI, Ingall TJ, Dodick DW, Brazdys K, Koch TC, Ward MP, Richemont PC; STARR Coinvestigators. Stroke telemedicine. Mayo Clin Proc. 2009;84(1):53-64. doi: 10.1016/S0025-6196(11)60808-2. Erratum In: Mayo Clin Proc. 2010 Apr;85(4):400.
Results Reference
derived
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Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
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