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

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telestroke
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Comprehensive stroke center, Ischemic stroke, Telestroke, Telemedicine, Secondary stroke prevention, COVID-19, SAR-Cov-2, pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M Health Fairview Southdale Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

In-Person (Conventional) Stroke Care

Telestroke Stroke Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Guideline-Based Inpatient Stroke Care
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 Outcome Measures

Stroke Recurrence
The composite rate of recurrent TIA, ischemic stroke, or hemorrhagic stroke 30 and 90 days post-discharge
Readmission Rate
Rates of 30 and 90 day readmission

Full Information

First Posted
February 15, 2021
Last Updated
April 19, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04761874
Brief Title
Telestroke at Comprehensive Stroke Center During the COVID-19 Pandemic
Acronym
TELECAST-CSC
Official Title
TELEstroke to CAre for STroke Patients at a Comprehensive Stroke Center During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Comprehensive stroke center, Ischemic stroke, Telestroke, Telemedicine, Secondary stroke prevention, COVID-19, SAR-Cov-2, pandemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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".
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-Person (Conventional) Stroke Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Telestroke Stroke Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telestroke
Intervention Description
In the telestroke cohort, acute ischemic stroke patients at a single comprehensive stroke center received their stroke care and management exclusively via telestroke.
Primary Outcome Measure Information:
Title
Guideline-Based Inpatient Stroke Care
Description
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).
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Secondary Outcome Measure Information:
Title
Stroke Recurrence
Description
The composite rate of recurrent TIA, ischemic stroke, or hemorrhagic stroke 30 and 90 days post-discharge
Time Frame
30 and 90 days post-hospital discharge
Title
Readmission Rate
Description
Rates of 30 and 90 day readmission
Time Frame
30 and 90 days post-hospital discharge
Other Pre-specified Outcome Measures:
Title
Transfer Rate
Description
Transfer rate
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Title
Diagnostic Stroke Evaluation
Description
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).
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Title
Secondary Stroke Prevention
Description
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).
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Title
Health Screening & Evaluation
Description
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).
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Title
Stroke Education
Description
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).
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Title
Length of Stay
Description
Length of patient hospitalization
Time Frame
Inpatient hospitalization defined as the patient's admission through their discharge date (on average < 1 week)
Title
Death
Description
Death rate 30 and 90 days post admission
Time Frame
30 and 90 days post-admission
Title
Time to antiplatelet administration
Description
Time from admission 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Streib, MD
Organizational Affiliation
The University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
M Health Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23370205
Citation
Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.
Results Reference
background
PubMed Identifier
26123479
Citation
Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Oct;46(10):3020-35. doi: 10.1161/STR.0000000000000074. Epub 2015 Jun 29.
Results Reference
background
PubMed Identifier
24788967
Citation
Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. Erratum In: Stroke. 2015 Feb;46(2):e54.
Results Reference
background
PubMed Identifier
28384077
Citation
Demaerschalk BM, Berg J, Chong BW, Gross H, Nystrom K, Adeoye O, Schwamm L, Wechsler L, Whitchurch S. American Telemedicine Association: Telestroke Guidelines. Telemed J E Health. 2017 May;23(5):376-389. doi: 10.1089/tmj.2017.0006. Epub 2017 Apr 6.
Results Reference
background
PubMed Identifier
24222046
Citation
Alberts MJ, Wechsler LR, Jensen ME, Latchaw RE, Crocco TJ, George MG, Baranski J, Bass RR, Ruff RL, Huang J, Mancini B, Gregory T, Gress D, Emr M, Warren M, Walker MD. Formation and function of acute stroke-ready hospitals within a stroke system of care recommendations from the brain attack coalition. Stroke. 2013 Dec;44(12):3382-93. doi: 10.1161/STROKEAHA.113.002285. Epub 2013 Nov 12.
Results Reference
background
PubMed Identifier
27811332
Citation
Wechsler LR, Demaerschalk BM, Schwamm LH, Adeoye OM, Audebert HJ, Fanale CV, Hess DC, Majersik JJ, Nystrom KV, Reeves MJ, Rosamond WD, Switzer JA; American Heart Association Stroke Council; Council on Epidemiology and Prevention; Council on Quality of Care and Outcomes Research. Telemedicine Quality and Outcomes in Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Jan;48(1):e3-e25. doi: 10.1161/STR.0000000000000114. Epub 2016 Nov 3.
Results Reference
background
PubMed Identifier
27566746
Citation
Kepplinger J, Barlinn K, Deckert S, Scheibe M, Bodechtel U, Schmitt J. Safety and efficacy of thrombolysis in telestroke: A systematic review and meta-analysis. Neurology. 2016 Sep 27;87(13):1344-51. doi: 10.1212/WNL.0000000000003148. Epub 2016 Aug 26.
Results Reference
background
PubMed Identifier
25147327
Citation
Muller-Barna P, Hubert GJ, Boy S, Bogdahn U, Wiedmann S, Heuschmann PU, Audebert HJ. TeleStroke units serving as a model of care in rural areas: 10-year experience of the TeleMedical project for integrative stroke care. Stroke. 2014 Sep;45(9):2739-44. doi: 10.1161/STROKEAHA.114.006141.
Results Reference
background
PubMed Identifier
28356464
Citation
Tarnutzer AA, Lee SH, Robinson KA, Wang Z, Edlow JA, Newman-Toker DE. ED misdiagnosis of cerebrovascular events in the era of modern neuroimaging: A meta-analysis. Neurology. 2017 Apr 11;88(15):1468-1477. doi: 10.1212/WNL.0000000000003814. Epub 2017 Mar 29.
Results Reference
background
PubMed Identifier
20508182
Citation
Ovbiagele B, Schwamm LH, Smith EE, Hernandez AF, Olson DM, Pan W, Fonarow GC, Saver JL. Recent nationwide trends in discharge statin treatment of hospitalized patients with stroke. Stroke. 2010 Jul;41(7):1508-13. doi: 10.1161/STROKEAHA.109.573618. Epub 2010 May 27.
Results Reference
background
PubMed Identifier
29367334
Citation
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:
Results Reference
background
PubMed Identifier
17928270
Citation
Lavallee PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Leseche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60. doi: 10.1016/S1474-4422(07)70248-X.
Results Reference
background
PubMed Identifier
17928046
Citation
Rothwell PM, Giles MF, Chandratheva A, Marquardt L, Geraghty O, Redgrave JN, Lovelock CE, Binney LE, Bull LM, Cuthbertson FC, Welch SJ, Bosch S, Alexander FC, Silver LE, Gutnikov SA, Mehta Z; Early use of Existing Preventive Strategies for Stroke (EXPRESS) study. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. Lancet. 2007 Oct 20;370(9596):1432-42. doi: 10.1016/S0140-6736(07)61448-2. Erratum In: Lancet. 2008 Feb 2;371(9610):386. Carasco-Alexander, Faye [corrected to Alexander, Faye C].
Results Reference
background
PubMed Identifier
31662037
Citation
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30. Erratum In: Stroke. 2019 Dec;50(12):e440-e441.
Results Reference
background

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Telestroke at Comprehensive Stroke Center During the COVID-19 Pandemic

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