TELECAST-TIA: Telestroke for Comprehensive Transient Ischemic Attack Care in Acute Stroke Ready Hospitals

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT03724110
Collaborator
(none)
300
5
45
60
1.3

Study Details

Study Description

Brief Summary

TELECAST-TIA is a prospective single-center study evaluating guideline-based transient ischemic attack (TIA) treatment at an Acute Stroke Ready Hospital (ASRH) pre- and post-initiation of a specialist telestroke inpatient rounding service. TELECAST-TIA will study the following clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, inpatient complications, and stroke recurrence rates. Additional relevant non-clinical data will include patient and provider satisfaction scores, transfer patterns, and a cost analysis.

Condition or Disease Intervention/Treatment Phase
  • Other: Telestroke

Detailed Description

Telestroke is a validated intervention that improves the triage and emergent treatment of acute stroke, specifically related to the use of intravenous thrombolysis. Effective urgent stroke evaluation and secondary stroke prevention is also essential to decrease the risk of recurrent stroke, however, there have been no studies to date examining the use of telestroke to improve delivery of non-emergent inpatient stroke care per American Heart Association (AHA) guidelines.

Currently, access to stroke specialist expertise is limited resulting in significant disparities in stroke care. Previous publications have identified that patients in rural areas may receive sub-optimal stroke care that does not follow accepted guideline recommendations. Telestroke is a cost-effective mechanism to deliver specialist stroke care to hospitals that do not have in-person stroke consultation available. The aim of TELECAST-TIA is to determine whether specialist telestroke inpatient rounding improves guideline-based TIA treatment when compared to non-specialist transient ischemic attack treatment.

The primary outcome of TELECAST-TIA is a composite score of 3 categories: diagnostic stroke evaluation, secondary stroke prevention, and stroke education. Individual components of the primary outcome were principally derived from AHA stroke guidelines. Additional outcome measures include individual analyses of the components of the primary outcome as well as the complication rate, stroke recurrence rate, transfer rate, patient and provider satisfaction levels, and a cost-analysis. All outcomes will be assessed at 1 year post-implementation, with data accruement starting after a 3-month lead in phase.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Telestroke for Comprehensive Transient Ischemic Attack Care in Acute Stroke Ready Hospitals
Actual Study Start Date :
Oct 2, 2018
Actual Primary Completion Date :
Jul 2, 2019
Anticipated Study Completion Date :
Jul 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Pre-Telestroke

Retrospective collection of defined metrics for all TIA patients admitted to the participating ASRH 2 years prior to implementation of an inpatient telestroke service.

Post-Telestroke

Prospective collection of defined metrics for all TIA patients admitted to the participating ASRH after implementation of an inpatient telestroke service.

Other: Telestroke
Telestroke is an audiovisual communication network that allows for coordination of stroke care from a distant 'hub' site (the telestroke provider location) to an originating 'spoke' site (patient location) in a HIPAA compliant fashion. In TELECAST-TIA, inpatient telestroke rounding will be used to oversee the urgent diagnostic TIA evaluation, secondary stroke prevention, and stroke education in patients admitted with TIA.
Other Names:
  • Telemedicine
  • Outcome Measures

    Primary Outcome Measures

    1. Composite score of TIA treatment (%) [1 year after implementation of the inpatient telestroke service]

      A 19-item global assessment of fundamental TIA treatment primarily informed by AHA guidelines/GWTG criteria, represented in 3 categories: Diagnostic evaluation (10 items): neurologist evaluation, LDL, HgA1c, head CT, brain MRI, intracranial vascular imaging, cervical vascular imaging, EKG, telemetry, and outpatient prolonged cardiac monitoring. Secondary prevention (6 items): antiplatelet, anticoagulation, statin, antihypertensives, diabetes management, and carotid revascularization. Stroke education (3 items): tobacco cessation counseling, exercise/lifestyle counseling, and signs of stroke. An item is not scored when not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.

    Secondary Outcome Measures

    1. Diagnostic TIA Evaluation [1 year after implementation of the inpatient telestroke service]

      A 10-item global assessment of diagnostic TIA evaluation as well as individual analysis of each item. Diagnostic evaluation (10 items): neurologist evaluation, LDL, HgA1c, head CT, brain MRI, intracranial vascular imaging, cervical vascular imaging, EKG, telemetry, and outpatient prolonged cardiac monitoring. An item is not scored when not indicated clinically (for example prolonged cardiac monitoring in a patient with known Afib or an MRI in a patient with an MRI incompatible pacemaker), therefore the composite scores will be reported and analyzed as percentages.

    2. Secondary Stroke Prevention [1 year after implementation of the inpatient telestroke service]

      A 6-item global assessment of secondary stroke prevention as well as individual analysis of each item. Secondary stroke prevention (6 items): antiplatelet, anticoagulation, statin, antihypertensives, diabetes management, and carotid revascularization. An item is not scored when not indicated clinically (for example deferring antiplatelet agents if a patient requires anticoagulation), therefore the composite scores will be reported and analyzed as percentages.

    3. Stroke Education [1 year after implementation of the inpatient telestroke service]

      A 3-item global assessment of stroke education as well as individual analysis of each item. Stroke education (3 items): tobacco cessation counseling, exercise/lifestyle counseling, and signs of stroke. An item is not scored when not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.

    4. Composite Stroke Recurrence [Measured at 3 months and at 1 year after discharge]

      The composite rate of recurrent TIA, ischemic, or hemorrhagic stroke at 3 months and one year post-stroke admission.

    Other Outcome Measures

    1. Admission rate [1 year after implementation of the inpatient telestroke service]

      Rate of admission versus discharge from the ED.

    2. Patient demographics [1 year after implementation of the inpatient telestroke service]

      Patient demographics of the TIA service will be assessed.

    3. Cost analysis [1 year after implementation of the inpatient telestroke service]

      A cost analysis incorporating the referring 'spoke' hospital and the central 'hub' hospital will be performed. Data collected will include hospital cost of admission, hospital admission reimbursement, transfer costs, and operational costs.

    4. Hospital length of stay [1 year after implementation of the inpatient telestroke service]

      The number of days of hospitalization for patients admitted with a primary diagnosis of TIA.

    5. Inpatient Telestroke Feasibility: Physician and Provider patient care time [1 year after implementation of the inpatient telestroke service]

      Total screen telestroke screen time will be assessed. This will be defined by the time that the telestroke patient visitation connection was made until it was terminated and also by the amount of time billed by the physician.

    6. Inpatient Telestroke Feasibility: Time from admission to consultation [1 year after implementation of the inpatient telestroke service]

      Time from both admission and consult order placement until consultation

    7. Composite score of fundamental TIA treatment at non-telestroke ASRHs (%) [1 year after implementation of the inpatient telestroke service]

      A 19-item assessment of fundamental TIA treatment (see primary outcome) at ASRHs within the same stroke network that do not have an inpatient telestroke service. These scores will serve as temporal controls for the primary outcome. An item is not scored if it is not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.

    8. Composite score of fundamental TIA treatment at the CSC hub site (%) [1 year after implementation of the inpatient telestroke service]

      A 19-item assessment of fundamental TIA treatment (see primary outcome) at the CSC hub site. This data will serve to compare the delivery of TIA treatment via telestroke vs. TIA treatment delivered in person at the hub site. An item is not scored if it is not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.

    9. Physician, Patient, Nursing satisfaction with Telestroke Rounding [1 year]

      Surveys will assess local physician, nursing, and patient satisfaction with the virtual telestroke service. Assessed items will include perceptions of convenience/inconvenience, quality of care provided, and satisfaction with the service relative to an in-person consulting service and/or transfer to a comprehensive stroke center for in-person consultation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 18 and above

    • Patients with the primary diagnosis of transient ischemic attack evaluated at the Fairview Ridges Hospital emergency room

    • Clinical diagnosis of transient ischemic attack by the treating stroke neurology service

    Exclusion Criteria:
    • Patients less than 18 years old

    • Patients who leave the hospital against medical advice

    • Patients who are felt to have an alternative diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    2 Grand Itasca Clinic and Hospital Grand Rapids Minnesota United States 55744
    3 Fairview Range Medical Center Hibbing Minnesota United States 55746
    4 Fairview Northland Medical Center Princeton Minnesota United States 55371
    5 Fairview Lakes Medical Center Wyoming Minnesota United States 55092

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT03724110
    Other Study ID Numbers:
    • NEUR-2017-26226-TIA
    First Posted:
    Oct 30, 2018
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Minnesota
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 24, 2022