Clinical trial NCT04761874: Telestroke at Comprehensive Stroke Center During the COVID-19 Pandemic
Official title: TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: Comprehensive stroke center
Ischemic stroke
Telestroke
Telemedicine
Secondary stroke prevention
COVID-19
SAR-Cov-2
pandemic
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pre-post interventional study following inpatient telestroke intervention for longitudinal treatment of acute ischemic stroke patients at a comprehensive stroke center.

The pre-treatment group is the conventional "in-person"cohort. The post-treatment group is the "telestroke" cohort.

The groups were non-randomly allocated. All acute ischemic stroke patients admitted during phase 1 were include in the "in-person" cohort and all acute ischemic stroke patients admitted during phase 2 were included in the "telestroke cohort".
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Guideline-Based Inpatient Stroke Care
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Secondary outcomes:
measure: Stroke Recurrence
timeFrame: 30 and 90 days post-hospital discharge
measure: Readmission Rate
timeFrame: 30 and 90 days post-hospital discharge
Other outcomes:
measure: Transfer Rate
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
measure: Diagnostic Stroke Evaluation
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
measure: Secondary Stroke Prevention
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
measure: Health Screening & Evaluation
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
measure: Stroke Education
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
measure: Length of Stay
timeFrame: Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
measure: Death
timeFrame: 30 and 90 days post-admission
measure: Time to antiplatelet administration
timeFrame: 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)
Locations:
city: Edina
country: United States
facility: M Health Fairview Southdale Hospital
state: Minnesota
Study officials:
affiliation: The University of Minnesota
name: Christopher Streib, MD
role: PRINCIPAL_INVESTIGATOR
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