Telestroke at Comprehensive Stroke Center During the COVID-19 Pandemic (TELECAST-CSC)

April 19, 2021 updated by: University of Minnesota

TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center During the COVID-19 Pandemic

TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center (TELECAST-CSC) during the COVID-19 pandemic is a pre-post study evaluating guideline-based acute ischemic stroke care following the implementation of inpatient telestroke at a comprehensive stroke center during the COVID-19 global pandemic. TELECAST-CSC compares two cohorts: the "in-person phase" (December 1, 2019-March 15, 2020), when all inpatient stroke team care was delivered conventionally in-person and the "telestroke phase" (March 16, 2020-June 29, 2020) when all inpatient stroke team care was delivered exclusively via telestroke as part of our healthcare system's pandemic response. We studied the following primarily clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, mortality, and stroke recurrence and readmission rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The SARS-Cov-2 virus originated in Wuhan China in 2019 and rapidly became a global pandemic. Beyond the pandemic, stroke care is further impacted directly by COVID-19-induced systemic inflammatory response and coagulopathy which leads to increased risk of embolic stroke and intracranial hemorrhage.

In the United States, the highest level of stroke care is provided to the most critically ill stroke patients at comprehensive stroke centers (CSCs). Many CSCs also utilize telestroke to deliver remote stroke care externally to partnering spoke hospitals without local stroke expertise in order to improve time-sensitive, emergent stroke interventions such as thrombolysis and thrombectomy. Conceptually, telestroke may also surmount pandemic-related barriers to stroke care delivery internally at CSCs and workflows incorporating telestroke have been adopted out of necessity. However, the efficacy of remote patient care via telestroke for stroke patients hospitalized at CSCs remains unclear. The aim of the TELECAST-CSC trial was to prospectively evaluate whether inpatient stroke specialist care provided via telestroke was equivalent to stroke care provided in-person during the COVID-19 pandemic.

TELECAST-CSC compares two cohorts: the "in-person phase" (December 1, 2019-March 15, 2020), when all inpatient stroke team care was delivered conventionally in-person and the "telestroke phase" (March 16, 2020-June 29, 2020) when all inpatient stroke team care was delivered exclusively via telestroke as part of our healthcare system's pandemic response. We studied the following primarily clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, and stroke recurrence rates.

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Not Applicable

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
      • Edina, Minnesota, United States, 55435
        • M Health Fairview Southdale Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 and above
  • Patients with the primary diagnosis of ischemic stroke admitted to Fairview Southdale Hospitals
  • 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 have an alternative diagnosis
  • Patients who opt out of the study

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: In-Person (Conventional) Stroke Care
Ischemic stroke patients admitted to a single academic, comprehensive stroke center from December 1, 2019-March 15, 2020 that were evaluated, managed, and treated by the stroke care team in person.
Experimental: Telestroke Stroke Care
Ischemic stroke patients admitted to a single academic, comprehensive stroke center from March 16, 2020-June 29, 2020 that were evaluated, managed, and treated by the stroke care team remotely via telestroke.
Other: Telestroke
In the telestroke cohort, acute ischemic stroke patients at a single comprehensive stroke center received their stroke care and management exclusively via telestroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline-Based Inpatient Stroke Care
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

A 24-item global assessment of fundamental inpatient acute ischemic stroke care informed by 2019 AHA guidelines comprising 4 categories:

Diagnostic evaluation: Neurologist evaluation, head CT or brain MRI, intracranial vascular imaging, cervical vascular imaging, LDL, HgA1C, troponin, EKG, telemetry, echocardiogram, and outpatient prolonged cardiac monitoring.

Secondary prevention: antiplatelet, dual antiplatelet, anticoagulation, statin, anti-hypertensives, diabetes management, symptomatic carotid revascularization. .

Health screening and evaluation: swallow evaluation, cognitive assessment, rehabilitation evaluation Stroke evaluation: tobacco cessation counseling, exercise/ lifestyle counseling, signs of stroke.

Each subject will be assessed for completion of these metrics.

When a metric is not applicable for a specific patient, it will not be included in the analysis of guideline-based inpatient stroke care (e.g. tobacco cessation in a non-smoker).
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Recurrence
Time Frame: 30 and 90 days post-hospital discharge
The composite rate of recurrent TIA, ischemic stroke, or hemorrhagic stroke 30 and 90 days post-discharge
30 and 90 days post-hospital discharge
Readmission Rate
Time Frame: 30 and 90 days post-hospital discharge
Rates of 30 and 90 day readmission
30 and 90 days post-hospital discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfer Rate
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Transfer rate
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Diagnostic Stroke Evaluation
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

The 11-item Diagnostic Stroke Evaluation assessment is one of four sub-components of the primary outcome.

Diagnostic evaluation metrics: Neurologist evaluation, head CT or brain MRI, intracranial vascular imaging, cervical vascular imaging, LDL, HgA1C, troponin, EKG, telemetry, echocardiogram, and outpatient prolonged cardiac monitoring.

Each subject will be assessed for completion of these metrics.

When a metric is not applicable for a specific patient, it will not be included in the analysis of guideline-based inpatient stroke care (e.g. tobacco cessation in a non-smoker).
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Secondary Stroke Prevention
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

The 8-item Secondary Stroke Prevention assessment is one of four sub-components of the primary outcome.

Secondary prevention: antiplatelet, dual antiplatelet, anticoagulation, statin, anti-hypertensives, diabetes management, symptomatic carotid revascularization.

Each subject will be assessed for completion of these metrics.

When a metric is not applicable for a specific patient, it will not be included in the analysis of guideline-based inpatient stroke care (e.g. tobacco cessation in a non-smoker).
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Health Screening & Evaluation
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

The 3-item Health Screening & Evaluation assessment is one of four sub-components of the primary outcome.

Health screening and evaluation: swallow evaluation, cognitive assessment, rehabilitation evaluation

Each subject will be assessed for completion of these metrics.

When a metric is not applicable for a specific patient, it will not be included in the analysis of guideline-based inpatient stroke care (e.g. tobacco cessation in a non-smoker).
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Stroke Education
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

The 3-item Stroke Education assessment is one of four sub-components of the primary outcome.

Each subject will be assessed for completion of these metrics.

Stroke evaluation: tobacco cessation counseling, exercise/ lifestyle counseling, signs of stroke.

When a metric is not applicable for a specific patient, it will not be included in the analysis of guideline-based inpatient stroke care (e.g. tobacco cessation in a non-smoker).
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Length of Stay
Time Frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Length of patient hospitalization
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Death
Time Frame: 30 and 90 days post-admission
Death rate 30 and 90 days post admission
30 and 90 days post-admission
Time to antiplatelet administration
Time Frame: From admission time until the first dose of antiplatelet administered in patients where antiplatelet treatment for secondary stroke prevention was indicated (assessed up to 1 week)
Time from admission to antiplatelet administration
From admission time until the first dose of antiplatelet administered in patients where antiplatelet treatment for secondary stroke prevention was indicated (assessed up to 1 week)

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Christopher Streib, MD, The 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)

December 1, 2019

Primary Completion (Actual)

June 29, 2020

Study Completion (Actual)

September 29, 2020

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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