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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

February 15, 2008
May 11, 2011
December 2007
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00623350 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera
Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience

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)

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

  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke, Acute
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623350
06-005731
Yes
Bart Demaerschalk, M.D., Mayo Clinic
Mayo Clinic
  • Arizona Department of Health Services
  • Yuma Regional Medical Center
  • Kingman Regional Medical Center
  • University of California, San Diego
Not Provided
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP