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Completed

NCT Number: NCT04761874

Telestroke at 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.

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Key information

Conditions

Stroke, Acute Brain Diseases COVID-19 Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronaviridae Infections Coronavirus Infections Infections Ischemic Stroke Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M Health Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telestroke

Other

In the telestroke cohort, acute ischemic stroke patients at a single comprehensive stroke center received their stroke care and management exclusively via telestroke.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. Readmission Rate

    Time frame: 30 and 90 days post-hospital discharge

    Rates of 30 and 90 day readmission

Other outcomes

  1. Transfer Rate

    Time frame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)

    Transfer rate

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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

  7. Death

    Time frame: 30 and 90 days post-admission

    Death rate 30 and 90 days post admission

  8. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: TELECAST-CSC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2021
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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