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StrokeSTARRNCT00829361

Stroke Telemedicine for Arizona Rural Residents Trial

A study testing Telemedicine in people with Stroke and Cerebral Infarction, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Stroke, Cerebral Infarction, Vascular Diseases
What is being tested?
Telemedicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
1 siteUnited States
Study dates
Oct 2008to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Unlikely to complete study through 90-day follow-up.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

Other trials in United States

About this study

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.

Read the 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.

Being tested
Telemedicine
Keywords
Telemedicine, Acute stroke, Rural, thrombosis, consultation, Stroke, Cerebral Infarction, Vascular diseases, brain ischemia, brain infarction, brain diseases, cerebrovascular disorders
Medical subject headings
Stroke, Cerebral Infarction, Vascular Diseases, Brain Ischemia, Brain Infarction, Brain Diseases, Cerebrovascular Disorders, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemedicineOther

    Two way site independent audio/video telemedicine system with DICOM.

Study groups in NCT00829361
Study groupRoleWhat they receive
TelemedicineOtherNot described
Receives: Other: Telemedicine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 90 days

Secondary outcomes (2)
  1. To assess the functional outcomes of acute stroke subjects by Barthel index and Modified Rankin Scale

    Measured: 90 days

  2. To assess the rate of intracranial hemorrhage post thrombolysis

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00829361
Sponsor's protocol ID
08-005156
Acronym
STARR
Status last verified
Nov 2015
First submitted
26 Jan 2009
Last updated
25 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35720454
  • 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.

    PubMed 22968466
  • 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.

    PubMed 19430275

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine in people with Stroke and Cerebral Infarction, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00829361, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.

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