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

Completed

Phase N/A Results

Trial Description

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
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.

Conditions

Interventions

  • Telephone Consult Other
    Intervention Desc: Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
  • Digital Observation Camera (Two way audio/video telemedicine consult )Other
    Intervention Desc: Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
  • Telephone Other
    Intervention Desc: Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Acute Stroke Telephone consult for the decision of tPA within 3 hours of symptoms onset.
  • Two way audio/video telemedicine consult Other
    Intervention Desc: Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.
    ARM 1: Kind: Experimental
    Label: 2
    Description: Acute Stroke consult via audio video telemedicine for the decision of tPA within 3 hours of symptom onset.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)will be randomized to one of two arms. [Two arms: Video Camera/Telemedicine (Intervention n = 25) and No Video Camera/Telephone only (Control n = 25)]

Outcomes

Type Measure Time Frame Safety Issue
Primary 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; to assess the completeness of the data collection in telemedicine versus telephone-only consultations.
Primary 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 90 days No
Primary to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only 90 days No
Primary to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations 90 days No
Primary to assess the completeness of the data collection in telemedicine versus telephone-only consultations. 90 days No

Sponsors