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

February 15, 2021 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
551

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Grand Rapids, Minnesota, United States, 55744
        • Grand Itasca Clinic and Hospital
      • Hibbing, Minnesota, United States, 55746
        • Fairview Range Medical Center
      • Princeton, Minnesota, United States, 55371
        • Fairview Northland Medical Center
      • Wyoming, Minnesota, United States, 55092
        • Fairview Lakes Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year after implementation of the inpatient telestroke service

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke service
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.
Measured at 3 months and at 1 year after discharge
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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke service

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke 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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke service
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.
1 year after implementation of the inpatient telestroke service
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.
2 years retrospective data and 1 year prospective data after implementation of the inpatient telestroke service at the participating ASRH
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.
2 years retrospective data and 1 year prospective data after implementation of the inpatient telestroke service at the participating ASRH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Streib, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEUR-2017-26226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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