Stroke Telemedicine for Arizona Rural Residents Trial
Condition: Stroke; Cerebral Infarction; Vascular Diseases; Brain Ischemia; Brain Infarction; Brain Diseases; Cerebrovascular Disorders
MeSH terms: Stroke; Brain Diseases; Cerebral Infarction; Cerebrovascular Disorders; Brain Ischemia; Brain Infarction; Vascular Diseases; Infarction; Ischemia
Study type: Interventional

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.
    

Intervention name(s): Telemedicine
Intervention type(s): Other
Intervention description(s): Two way site independent audio/video telemedicine system with DICOM.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telemedicine; Acute stroke; Rural; thrombosis; consultation; Stroke; Cerebral Infarction; Vascular diseases; brain ischemia; brain infarction; brain diseases; cerebrovascular disorders