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
  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

Resource links provided by NLM:


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.

  Hide Detailed Description

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.
  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:
Additional 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
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 April 23, 2014