Stroke Telemedicine for Arizona Rural Residents Trial (STARR)

This study has been completed.
Sponsor:
Collaborator:
Arizona Department of Health Services
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00829361
First received: January 26, 2009
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.


Condition Intervention
Stroke
Cerebral Infarction
Vascular Diseases
Brain Ischemia
Brain Infarction
Brain Diseases
Cerebrovascular Disorders
Other: Telemedicine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stroke Telemedicine for Arizona Rural Residents Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the functional outcomes of acute stroke subjects by Barthel index and Modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • To assess the rate of intracranial hemorrhage post thrombolysis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 447
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Telemedicine
    Two way site independent audio/video telemedicine system with DICOM.
  Hide Detailed Description

Detailed Description:

Background:

Acute stroke resources and care are deficient in Arizona's rural communities. Stroke telemedicine is a proven modality for overcoming the deficiency. Stroke telemedicine allows a telephonic consultation and/or two-way audio video consultation between a stroke neurologist and a stroke patient at a remotely located emergency department. University of California San Diego Stroke Center has completed an NIH funded randomized controlled trial, STRokE DOC, comparing telephonic consultations to video consultations. In that trial, video telemedicine consultations resulted in more accurate decision making compared with telephone consultations. The video telemedicine consultative modality provides the rural stroke patient with the opportunity to receive expert stroke care, interpretation of neuroimaging, determination of appropriate acute therapy, and recommendations regarding need for transfer to a higher level of care. Mayo Clinic Arizona is currently completing a state funded feasibility trial, STRokE DOC Arizona (06-005731), as a preliminary step toward establishing a state wide stroke telemedicine network, STARR. The STARR network plan should include the prospective collection, recording, and regular analysis of telestroke patient consultation data for the purpose of quality measure assessment and improvement.

Objective:

The objective of this research is to establish a system for the prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.

Methods:

The STARR network consists of a primary stroke center hub (Mayo Clinic Hospital) that serves multiple spoke hospitals in remote and rural regions of the state (e.g. Kingman and Yuma Regional Medical Centers, La Paz Regional Hospital and Copper Queen Community Hospital). Mayo Clinic vascular neurologists, who have licenses and privileges to practice teleneurology at spoke hospitals in the state, participate in a 24/7 Mayo Clinic telestroke hotline. When an acute stroke patient presents to a STARR network participating spoke hospital emergency department, a stroke alert is activated and the hotline is phoned. An on-call vascular neurologist receives the pager notification and communicates with the referring emergency physician. The telestroke consultation will begin by telephone and will be supplemented by audio-video telemedicine communication and teleradiology. The patient is registered at Mayo Clinic and a registration number is generated by the house supervisor. Emergency neurology care is rendered. Every participating spoke hospital emergency physician is already a sub-investigator in telestroke research and has completed HSRP training and certification. The Mayo Clinic IRB has served as the central IRB of record for state funded Mayo Clinic telestroke research. The patient or legal designate will be approached by either the spoke emergency physician investigator and/or the hub neurologist investigator (via telemedicine camera) for consent to proceed with telestroke consultation, and to acquire, store, and analyze data concerning the acute stroke care and outcome of the patient. Data sources will include the Mayo Clinic electronic transcribed telestroke consultation note, the emergency department nursing and physician records, the admission consultation and diagnostic tests records, hospital discharge note, and the content of a brief 90 day follow-up phone call by the research coordinator to patient and/or family member. The licensed neurologists already have authorization to access patient spoke hospital records as part of their clinical privileges, but the designated Mayo Clinic research coordinator will have the responsibility to extract data from the sources and enter it into the registry. The STARR registry data elements will be exactly the same as the established and familiar data elements for the STRokE DOC Arizona trial, for the purposes of continuity. Mayo Clinic Arizona research biostatistics group will develop the electronic data manager and conduct and report analyses monthly to the telestroke research group.

  Eligibility

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

Inclusion Criteria:

  • Patients presenting to Rural Emergency Department within 12 hours of acute stroke symptom onset.
  • Written informed consent.

Exclusion Criteria:

  • Unlikely to complete study through 90-day follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829361

Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Arizona Department of Health Services
Investigators
Principal Investigator: Bart M. Demerschalk, M.D. Mayo Clinic
Principal Investigator: Bentley J. Bobrow, M.D. Mayo Clinic
Study Director: Dwight D Channer, MS Mayo Clinic
  More Information

Additional Information:
No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00829361     History of Changes
Other Study ID Numbers: 08-005156
Study First Received: January 26, 2009
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Telemedicine
Acute stroke
Rural
thrombosis
consultation
Stroke
Cerebral Infarction
Vascular diseases
brain ischemia
brain infarction
brain diseases
cerebrovascular disorders

Additional relevant MeSH terms:
Brain Diseases
Cerebral Infarction
Stroke
Brain Ischemia
Cerebrovascular Disorders
Infarction
Ischemia
Vascular Diseases
Brain Infarction
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 17, 2014