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

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ClinicalTrials.gov Identifier: NCT00623350
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : May 12, 2011
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

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)


Condition or disease Intervention/treatment Phase
Stroke, Acute Other: Telephone Other: Two way audio/video telemedicine consult Not Applicable

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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.

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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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience
Study Start Date : December 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 [ Time Frame: 90 days ]
  2. 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 ]
  3. to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations [ Time Frame: 90 days ]
  4. to assess the completeness of the data collection in telemedicine versus telephone-only consultations. [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bart Demaerschalk, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00623350     History of Changes
Other Study ID Numbers: 06-005731
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011

Keywords provided by Mayo Clinic:
Telemedicine
Stroke, Acute
Rural
Thrombolysis
Consultation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases