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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

Tracking Information
First Submitted Date September 13, 2018
First Posted Date September 17, 2018
Last Update Posted Date July 17, 2020
Actual Study Start Date October 2, 2018
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2018)
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.
Original Primary Outcome Measures
 (submitted: September 13, 2018)
Composite score of inpatient stroke care [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
A 23-point score encompassing the fundamental aspects of inpatient acute ischemic stroke care primarily informed by AHA guidelines/GWTG criteria, represented in 4 categories:
  • Diagnostic evaluation (10 points): 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 points): antiplatelet, anticoagulation, statin, antihypertensives, diabetes management, and carotid revascularization.
  • Health Screening & Evaluation (4 points): Swallow evaluation, cognitive assessment, depression screening, and rehabilitation evaluation.
  • Stroke Education (3 points): tobacco cessation counseling, exercise/lifestyle counseling, and signs of stroke.
A category is not scored when the specific intervention is not indicated, i.e. stroke patients who don't require anticoagulation.
Change History
Current Secondary Outcome Measures
 (submitted: September 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: September 13, 2018)
  • Diagnostic Stroke Evaluation [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Composite diagnostic stroke evaluation score and individual assessment of each component
  • Secondary Stroke Prevention [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Composite secondary stroke prevention score and individual assessment of each component.
  • Health Screening & Evaluation [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Composite health screening and evaluation score and individual assessment of each component.
  • Stroke Education [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Composite stroke education score and individual assessment of each component.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: September 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: September 13, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Telestroke feasibility [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    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.
  • Composite score of fundamental inpatient stroke care at non-telestroke ASRHs [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    The composite score of fundamental inpatient stroke care at ASRHs within our stroke network without a virtual Telestroke service. These scores will serve as temporal controls for any changes observed in the composite score of fundamental inpatient stroke care at our telestroke site.
  • Composite score of fundamental inpatient stroke care at our CSC hub site [ Time Frame: 1 year after implementation of the inpatient telestroke service ]
    Composite score of fundamental inpatient stroke care at our CSC hub site
 
Descriptive Information
Brief Title Telestroke for Comprehensive Stroke Care in Acute Stroke Ready Hospitals
Official Title Telestroke for Comprehensive Stroke Care in Acute Stroke Ready Hospitals
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition Stroke
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: Telestroke
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christopher Streib, MD 612-625-1969 streib@umn.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03672890
Other Study ID Numbers NEUR-2017-26226
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators Not Provided
Investigators
Principal Investigator: Christopher Streib, MD University of Minnesota
PRS Account University of Minnesota
Verification Date July 2020