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

Purpose

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)

Condition	Intervention
Stroke, Acute	Other: Telephone Other: Two way audio/video telemedicine consult

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience

Further study details as provided by Mayo Clinic:

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 [ 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 ]

Enrollment:	60
Study Start Date:	December 2007
Study Completion Date:	January 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Acute Stroke Telephone consult for the decision of tPA within 3 hours of symptoms onset.	Other: Telephone Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
Active Comparator: 2 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 Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623350

Locations

United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054

Sponsors and Collaborators

Mayo Clinic

Arizona Department of Health Services

Yuma Regional Medical Center

Kingman Regional Medical Center

University of California, San Diego

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Bart Demaerschalk, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00623350 History of Changes
Other Study ID Numbers:	06-005731
Study First Received:	February 15, 2008
Last Updated:	May 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Telemedicine
Stroke, Acute
Rural
Thrombolysis
Consultation

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013