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

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ClinicalTrials.gov Identifier: NCT03724110
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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
Transient Ischemic Attack 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Telestroke for Comprehensive Transient Ischemic Attack Care in Acute Stroke Ready Hospitals
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : July 2, 2019
Estimated Study Completion Date : July 2, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Telemedicine




Primary Outcome Measures :
  1. Composite score of TIA treatment (%) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Rate of admission versus discharge from the ED.

  2. Patient demographics [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Patient demographics of the TIA service will be assessed.

  3. Cost analysis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 (%) [ Time Frame: 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 (%) [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted with a primary diagnosis of transient ischemic attack at a participating ASRH two years before and one year after implementation of the telestroke inpatient service.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724110


Contacts
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Contact: Christopher Streib, MD 6126251969 streib@umn.edu

Locations
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United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Christopher Streib, MD    612-625-1969    streib@umn.edu   
Grand Itasca Clinic and Hospital Not yet recruiting
Grand Rapids, Minnesota, United States, 55744
Contact: Christopher Streib, MD    612-625-1969    streib@umn.edu   
Fairview Range Medical Center Not yet recruiting
Hibbing, Minnesota, United States, 55746
Contact: Christopher Streib, MD    612-625-1969    streib@umn.edu   
Fairview Northland Medical Center Not yet recruiting
Princeton, Minnesota, United States, 55371
Contact: Christopher Streib, MD    612-625-1969    streib@umn.edu   
Fairview Lakes Medical Center Not yet recruiting
Wyoming, Minnesota, United States, 55092
Contact: Christopher Streib, MD    612-625-1969    streib@umn.edu   
Sponsors and Collaborators
University of Minnesota
Additional Information:

Publications:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03724110    
Other Study ID Numbers: NEUR-2017-26226-TIA
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Telestroke
Telemedicine
Secondary stroke prevention
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia