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

Stroke, Acute Clinical Trial

Official title:

Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623350
• Other study ID #: 06-005731
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: May 11, 2011
• Start date: December 2007
• Est. completion date: January 2009

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• Telephone
Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona Department of Health Services, Kingman Regional Medical Center, University of California, San Diego, Yuma Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	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		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