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Stroke Telemedicine for Arizona Rural Residents Trial (STARR)

Primary Purpose

Stroke, Cerebral Infarction, Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Telemedicine, Acute stroke, Rural, thrombosis, consultation, Stroke, Cerebral Infarction, Vascular diseases, brain ischemia, brain infarction, brain diseases, cerebrovascular disorders

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Telemedicine

Arm Description

Outcomes

Primary Outcome Measures

To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine

Secondary Outcome Measures

To assess the functional outcomes of acute stroke subjects by Barthel index and Modified Rankin Scale
To assess the rate of intracranial hemorrhage post thrombolysis

Full Information

First Posted
January 26, 2009
Last Updated
November 23, 2015
Sponsor
Mayo Clinic
Collaborators
Arizona Department of Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00829361
Brief Title
Stroke Telemedicine for Arizona Rural Residents Trial
Acronym
STARR
Official Title
Stroke Telemedicine for Arizona Rural Residents Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
Arizona Department of Health Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Infarction, Vascular Diseases, Brain Ischemia, Brain Infarction, Brain Diseases, Cerebrovascular Disorders
Keywords
Telemedicine, Acute stroke, Rural, thrombosis, consultation, Stroke, Cerebral Infarction, Vascular diseases, brain ischemia, brain infarction, brain diseases, cerebrovascular disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Two way site independent audio/video telemedicine system with DICOM.
Primary Outcome Measure Information:
Title
To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine
Time Frame
90 days
Secondary Outcome Measure Information:
Title
To assess the functional outcomes of acute stroke subjects by Barthel index and Modified Rankin Scale
Time Frame
90 days
Title
To assess the rate of intracranial hemorrhage post thrombolysis
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart M. Demerschalk, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bentley J. Bobrow, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dwight D Channer, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35720454
Citation
Demaerschalk BM, Aguilar MI, Ingall TJ, Dodick DW, Vargas BB, Channer DD, Boyd EL, Kiernan TEJ, Fitz-Patrick DG, Collins JG, Hentz JG, Noble BN, Wu Q, Brazdys K, Bobrow BJ. Stroke Telemedicine for Arizona Rural Residents, the Legacy Telestroke Study. Telemed Rep. 2022 Mar 14;3(1):67-78. doi: 10.1089/tmr.2022.0002. eCollection 2022.
Results Reference
derived
PubMed Identifier
22968466
Citation
Demaerschalk BM, Vargas JE, Channer DD, Noble BN, Kiernan TE, Gleason EA, Vargas BB, Ingall TJ, Aguilar MI, Dodick DW, Bobrow BJ. Smartphone teleradiology application is successfully incorporated into a telestroke network environment. Stroke. 2012 Nov;43(11):3098-101. doi: 10.1161/STROKEAHA.112.669325. Epub 2012 Sep 11.
Results Reference
derived
PubMed Identifier
19430275
Citation
Capampangan DJ, Wellik KE, Bobrow BJ, Aguilar MI, Ingall TJ, Kiernan TE, Wingerchuk DM, Demaerschalk BM. Telemedicine versus telephone for remote emergency stroke consultations: a critically appraised topic. Neurologist. 2009 May;15(3):163-6. doi: 10.1097/NRL.0b013e3181a4b79c.
Results Reference
derived
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Stroke Telemedicine for Arizona Rural Residents Trial

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