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

This study has been completed.

Sponsor:

Collaborators:

Arizona Department of Health Services

Yuma Regional Medical Center

Kingman Regional Medical Center

University of California, San Diego

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00623350

First received: February 15, 2008

Last updated: May 11, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 15, 2008
Last Updated Date	May 11, 2011
Start Date ^ICMJE	December 2007
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 25, 2008)	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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations [ Time Frame: 90 days ] [ Designated as safety issue: No ] to assess the completeness of the data collection in telemedicine versus telephone-only consultations. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00623350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
Official Title ^ICMJE	Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Stroke, Acute
Intervention ^ICMJE	Other: Telephone Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset. Other: Two way audio/video telemedicine consult Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
Study Arm (s)	Active Comparator: 1 Acute Stroke Telephone consult for the decision of tPA within 3 hours of symptoms onset. Intervention: Other: Telephone Active Comparator: 2 Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset. Intervention: Other: Two way audio/video telemedicine consult
Publications *	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. Epub 2010 Apr 29. 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. 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. Epub 2012 Mar 8. 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. 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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	January 2009
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00623350
Other Study ID Numbers ^ICMJE	06-005731
Has Data Monitoring Committee	Yes
Responsible Party	Bart Demaerschalk, M.D., Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Arizona Department of Health Services Yuma Regional Medical Center Kingman Regional Medical Center University of California, San Diego
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top