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Telestroke for Comprehensive Stroke Care in Acute Stroke Ready Hospitals (TELECAST)

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ClinicalTrials.gov Identifier: NCT03672890
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
TELEstroke for Comprehensive Stroke Care in Acute Stroke Ready HospiTals (TELECAST) is a prospective single-center study evaluating guideline-based acute ischemic stroke care at an Acute Stroke Ready Hospital (ASRH) pre- and post-initiation of a specialist telestroke inpatient rounding service. TELECAST 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
Stroke 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 is to determine whether specialist telestroke inpatient rounding improves guideline-based acute stroke care when compared to non-specialist stroke care.

The primary outcome of TELECAST is a composite score comprising 4 categories: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, and stroke education. Individual components of the primary outcome were primarily 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 beginning 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 Stroke Care in Acute Stroke Ready Hospitals
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pre-Telestroke
Retrospective collection of defined metrics for all ischemic stroke 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 ischemic stroke 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, inpatient telestroke rounding will be used to oversee the urgent diagnostic stroke evaluation, secondary stroke prevention, health screening & evaluation, and stroke education in patients admitted with stroke.




Primary Outcome Measures :
  1. Composite score of inpatient stroke care (%) [ Time Frame: 1 year after implementation of the inpatient telestroke service ]

    A 23-item global assessment of fundamental inpatient acute ischemic stroke care primarily informed by AHA guidelines/GWTG criteria comprising 4 categories:

    • Diagnostic evaluation (10 items): neurologist evaluation, LDL, HgA1c, troponin, head CT or 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.
    • Health screening & evaluation (4 items): swallow evaluation, cognitive assessment, depression screening, and rehabilitation evaluation.
    • 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 Stroke Evaluation [ Time Frame: 1 year after implementation of the inpatient telestroke service ]

    A 10-item global assessment of inpatient diagnostic stroke evaluation as well as individual analysis of each item.

    Diagnostic evaluation (10 items): neurologist evaluation, LDL, HgA1c, troponin, head CT or 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 atrial fibrillation), 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. Health Screening & Evaluation [ Time Frame: 1 year after implementation of the inpatient telestroke service ]

    A 4-item global assessment of health screening and evaluation as well as individual analysis of each item.

    Health screening & evaluation (4 items): swallow evaluation, cognitive assessment, depression screening, and rehabilitation evaluation.

    An item is not scored when not indicated clinically, therefore the composite scores will be reported and analyzed as percentages.


  4. 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.


  5. 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. Acute Stroke Care [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Appropriate and timely delivery of acute stroke interventions per AHA guidelines.

  2. Transfer patterns [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Transfer rate and discharge destinations. We will also study the impact of changing transfer patterns on baseline patient demographics of the inpatient stroke service at the participating ASRH.

  3. Inpatient complications [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Inpatient complications include: hemorrhagic transformation, UTI, PE, pneumonia, DVT, falls, stage II or greater decubitus ulcers, and mortality.

  4. Provider and patient satisfaction [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Provider and patient satisfaction with the telestroke service will be assessed with a questionnaire administered to providers and patients receiving the service.

  5. Cost analysis [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    A cost analysis incorporating the spoke site and the central (hub) site will be performed. Data collected will include hospital cost of admission, hospital admission reimbursement, transfer costs, and operational costs.

  6. 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 stroke.

  7. Telestroke feasibility [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Descriptive data related to the feasibility of telestroke implementation will be collected. This includes time from admission to when the patient is seen, duration of telestroke screen time, and physician, patient, and nursing satisfaction.

  8. 14. Composite score of fundamental inpatient stroke care at non-telestroke ASRHs (%), including Fairview Hospitals: Range, Grand Itasca, Lakes, and Northland [ Time Frame: 2 years retrospective data and 1 year prospective data after implementation of the inpatient telestroke service at the participating ASRH ]

    A 23-item assessment of fundamental inpatient stroke care (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.


  9. Composite score of fundamental inpatient stroke care at the CSC hub site (%) [ Time Frame: 2 years retrospective data and 1 year prospective data after implementation of the inpatient telestroke service at the participating ASRH ]

    A 23-item assessment of fundamental inpatient stroke care (see primary outcome) at the CSC hub site. This data will serve to compare the delivery of inpatient stroke care via inpatient telestroke vs. stroke care 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 diagnosis of acute ischemic stroke 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 ischemic stroke admitted to Fairview Ridges Hospital
  • Evidence of stroke on MRI or CT or clinical diagnosis of acute ischemic stroke by the treating stroke service

Exclusion Criteria:

  • Patients less than 18 years old
  • Patients who leave the hospital against medical advice
  • Patients with goals of care that impact the stroke evaluation (i.e. comfort measures)
  • Patients who are felt to have an alternative diagnosis
  • Patients who are transferred for higher-level stroke care such as endovascular thrombectomy or decompressive craniectomy

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): NCT03672890


Contacts
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Contact: Christopher Streib, MD 612-625-1969 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
Investigators
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Principal Investigator: Christopher Streib, MD University of Minnesota
Additional Information:

Publications:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03672890    
Other Study ID Numbers: NEUR-2017-26226
First Posted: September 17, 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
Stroke
Secondary stroke prevention
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases