Advancing Telestroke Care: A Prospective Observational Study (ATC)

December 4, 2013 updated by: National Stroke Association, United States
This study will promote the development and economic sustainability of telemedicine for acute stroke treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of this study is to promote the development and economic sustainability of telemedicine for acute stroke treatment. The study's objectives are 1) to determine if the use of telemedicine consultations for stroke patients will improve their care per guidelines compared to stroke patients treated by control hospitals; and 2) to determine if the care per guidelines provided via telemedicine consultations for stroke patients will be similar or equivalent to care per guidelines provided to stroke patients treated at hub hospitals.

The Advancing Telestroke Care study will establish treatment and outcomes in three distinct study cohorts: hub telemedicine hospital, spoke telemedicine hospital and non-telemedicine control hospital.

Study Type

Observational

Enrollment (Actual)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

600 subjects meeting inclusion and exclusion criteria will be enrolled consecutively over approximately 12 months and followed for 90 days post-stroke.

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years old
  • Acute ischemic stroke within 12 hours of stroke onset

Exclusion Criteria:

  • Life expectancy less than 90 days
  • Patient unwilling to participate in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hub Hospital
Hub Hospital Cohort: Joint Commission-certified Primary Stroke Centers where patients are treated using hospital-based stroke teams and pathways; these hospital personnel also provide telemedicine consultation to satellite hospitals.
Spoke Hospital
Spoke Hospital Cohort: non-stroke center certified sites, where patients are treated at an in-network telestroke community hospital using telemedicine technology with consultation provided by physicians from a hub hospital.
Control Hospital
Control Hospital Cohort: non-stroke center certified sites with no telemedicine services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV tPA administration
Time Frame: Day 7/Discharge
Correctness of decisions regarding IV tPA administration in acute stroke
Day 7/Discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Study Assessments
Time Frame: Day 7 and/or Day 30 and/or Day 90 and/or at discharge
There are 23 assessments, after stroke, for outcome measures. They include: hospital transfers, treatment with reperfusions therapies, treatment with antiplatelets, hypertension treatment, hyperglycemia treatment, hyperlipidemia treatment, symptomatic ICH, mortality, imaging/diagnostic data, stroke and rehab scale scores, number of hospitalizations since last assessment, hospital LOS, discharge location, number of physician visits, and work status.
Day 7 and/or Day 30 and/or Day 90 and/or at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Stroke Association, United States

Collaborators

Mayo Clinic
University of Southern California
University of Utah
Swedish Medical Center
California Pacific Medical Center

Investigators

  • Principal Investigator: Gene Sung, MD, MPH, University of Southern California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSA Telestroke

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe