NCT04761874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

February 15, 2021

Last Update Submit

April 19, 2021

Conditions

Keywords

Comprehensive stroke centerIschemic strokeTelestrokeTelemedicineSecondary stroke preventionCOVID-19SAR-Cov-2pandemic

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (2)

  • Stroke Recurrence

    30 and 90 days post-hospital discharge

  • Readmission Rate

    30 and 90 days post-hospital discharge

Other Outcomes (8)

  • Transfer Rate

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

  • Diagnostic Stroke Evaluation

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

  • Secondary Stroke Prevention

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

  • +5 more other outcomes

Study Arms (2)

In-Person (Conventional) Stroke Care

NO INTERVENTION

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.

Telestroke Stroke Care

EXPERIMENTAL

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

Interventions

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

Telestroke Stroke Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M Health Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Related Publications (14)

  • 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.

    PMID: 23370205BACKGROUND
  • 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.

    PMID: 26123479BACKGROUND
  • 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.

    PMID: 24788967BACKGROUND
  • 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.

    PMID: 28384077BACKGROUND
  • 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.

    PMID: 24222046BACKGROUND
  • 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.

    PMID: 27811332BACKGROUND
  • 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.

    PMID: 27566746BACKGROUND
  • 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.

    PMID: 25147327BACKGROUND
  • 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.

    PMID: 28356464BACKGROUND
  • 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.

    PMID: 20508182BACKGROUND
  • 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.

    PMID: 29367334BACKGROUND
  • 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.

    PMID: 17928270BACKGROUND
  • 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.

    PMID: 17928046BACKGROUND
  • 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.

    PMID: 31662037BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeCOVID-19

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christopher Streib, MD

    The University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 21, 2021

Study Start

December 1, 2019

Primary Completion

June 29, 2020

Study Completion

September 29, 2020

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations