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Advancing Telestroke Care: A Prospective Observational Study (ATC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Southern California
Mayo Clinic
Swedish Medical Center
University of Utah
California Pacific Medical Center
Information provided by (Responsible Party):
National Stroke Association, United States
ClinicalTrials.gov Identifier:
NCT01226862
First received: October 20, 2010
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

This study will promote the development and economic sustainability of telemedicine for acute stroke treatment.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advancing Telestroke Care: A Prospective Observational Study

Further study details as provided by National Stroke Association, United States:

Primary Outcome Measures:
  • IV tPA administration [ Time Frame: Day 7/Discharge ] [ Designated as safety issue: No ]
    Correctness of decisions regarding IV tPA administration in acute stroke


Secondary Outcome Measures:
  • Multiple Study Assessments [ Time Frame: Day 7 and/or Day 30 and/or Day 90 and/or at discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: December 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226862

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
National Stroke Association, United States
University of Southern California
Mayo Clinic
Swedish Medical Center
University of Utah
California Pacific Medical Center
Investigators
Principal Investigator: Gene Sung, MD, MPH University of Southern California, Los Angeles
  More Information

No publications provided

Responsible Party: National Stroke Association, United States
ClinicalTrials.gov Identifier: NCT01226862     History of Changes
Other Study ID Numbers: NSA Telestroke
Study First Received: October 20, 2010
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by National Stroke Association, United States:
Stroke
Telemedicine
Telestroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013