Telestroke for Comprehensive Stroke Care in Acute Stroke Ready Hospitals

Stroke Clinical Trial

— TELECAST  

Official title:

Telestroke for Comprehensive Stroke Care in Acute Stroke Ready Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672890
• Other study ID #: NEUR-2017-26226
• Status: Completed
• Start date: October 2, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

TELEstroke for Comprehensive Stroke Care in Acute Stroke Ready HospiTals (TELECAST) is a prospective single-center study evaluating guideline-based acute ischemic stroke care at an Acute Stroke Ready Hospital (ASRH) pre- and post-initiation of a specialist telestroke inpatient rounding service. TELECAST will study the following clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, inpatient complications, and stroke recurrence rates. Additional relevant non-clinical data will include patient and provider satisfaction scores, transfer patterns, and a cost analysis.

Description:

Telestroke is a validated intervention that improves the triage and emergent treatment of acute stroke, specifically related to the use of intravenous thrombolysis. Effective urgent stroke evaluation and secondary stroke prevention is also essential to decrease the risk of recurrent stroke, however, there have been no studies to date examining the use of telestroke to improve delivery of non-emergent inpatient stroke care per American Heart Association (AHA) guidelines.

Currently, access to stroke specialist expertise is limited resulting in significant disparities in stroke care. Previous publications have identified that patients in rural areas may receive sub-optimal stroke care that does not follow accepted guideline recommendations. Telestroke is a cost-effective mechanism to deliver specialist stroke care to hospitals that do not have in-person stroke consultation available. The aim of TELECAST is to determine whether specialist telestroke inpatient rounding improves guideline-based acute stroke care when compared to non-specialist stroke care.

The primary outcome of TELECAST is a composite score comprising 4 categories: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, and stroke education. Individual components of the primary outcome were primarily derived from AHA stroke guidelines. Additional outcome measures include individual analyses of the components of the primary outcome as well as the complication rate, stroke recurrence rate, transfer rate, patient and provider satisfaction levels, and a cost-analysis. All outcomes will be assessed at 1 year post-implementation, with data accruement beginning after a 3-month lead in phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: July 1, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and above

• Patients with the primary diagnosis of ischemic stroke admitted to Fairview Ridges Hospital

• 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 are felt to have an alternative diagnosis

• Patients who are transferred for higher-level stroke care such as endovascular thrombectomy or decompressive craniectomy

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Telestroke
Telestroke is an audiovisual communication network that allows for coordination of stroke care from a distant 'hub' site (the telestroke provider location) to an originating 'spoke' site (patient location) in a HIPAA compliant fashion. In TELECAST, inpatient telestroke rounding will be used to oversee the urgent diagnostic stroke evaluation, secondary stroke prevention, health screening & evaluation, and stroke education in patients admitted with stroke.

Locations

Country	Name	City	State
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Grand Itasca Clinic and Hospital	Grand Rapids	Minnesota
United States	Fairview Range Medical Center	Hibbing	Minnesota
United States	Fairview Northland Medical Center	Princeton	Minnesota
United States	Fairview Lakes Medical Center	Wyoming	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Lavallée 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, Lesèche 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. — View Citation

Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, Thomas RG, Lyden PD. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008 Sep;7(9):787-95. doi: 10.1016/S1474-4422(08)70171-6. — View Citation

Müller-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. — View 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. — View 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. — View 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. Review. Erratum in: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:. — View 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. Erratum in: Lancet. 2008 Feb 2;371(9610):386. Carasco-Alexander, Faye [corrected to Alexander, Faye C]. — View Citation

Switzer JA, Demaerschalk BM, Xie J, Fan L, Villa KF, Wu EQ. Cost-effectiveness of hub-and-spoke telestroke networks for the management of acute ischemic stroke from the hospitals' perspectives. Circ Cardiovasc Qual Outcomes. 2013 Jan 1;6(1):18-26. doi: 10.1161/CIRCOUTCOMES.112.967125. Epub 2012 Dec 4. — View 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. Review. — View 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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Stroke Care	Appropriate and timely delivery of acute stroke interventions per AHA guidelines.	1 year after implementation of the inpatient telestroke service
Other	Transfer patterns	Transfer rate and discharge destinations. We will also study the impact of changing transfer patterns on baseline patient demographics of the inpatient stroke service at the participating ASRH.	1 year after implementation of the inpatient telestroke service
Other	Inpatient complications	Inpatient complications include: hemorrhagic transformation, UTI, PE, pneumonia, DVT, falls, stage II or greater decubitus ulcers, and mortality.	1 year after implementation of the inpatient telestroke service
Other	Provider and patient satisfaction	Provider and patient satisfaction with the telestroke service will be assessed with a questionnaire administered to providers and patients receiving the service.	1 year after implementation of the inpatient telestroke service
Other	Cost analysis	A cost analysis incorporating the spoke site and the central (hub) site will be performed. Data collected will include hospital cost of admission, hospital admission reimbursement, transfer costs, and operational costs.	1 year after implementation of the inpatient telestroke service
Other	Hospital Length of Stay	The number of days of hospitalization for patients admitted with a primary diagnosis of stroke.	1 year after implementation of the inpatient telestroke service
Other	Telestroke feasibility	Descriptive data related to the feasibility of telestroke implementation will be collected. This includes time from admission to when the patient is seen, duration of telestroke screen time, and physician, patient, and nursing satisfaction.	1 year after implementation of the inpatient telestroke service
Other	14. Composite score of fundamental inpatient stroke care at non-telestroke ASRHs (%), including Fairview Hospitals: Range, Grand Itasca, Lakes, and Northland	A 23-item assessment of fundamental inpatient stroke care (see primary outcome) at ASRHs within the same stroke network that do not have an inpatient telestroke service. These scores will serve as temporal controls for the primary outcome.; An item is not scored if it is not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.	2 years retrospective data and 1 year prospective data after implementation of the inpatient telestroke service at the participating ASRH
Other	Composite score of fundamental inpatient stroke care at the CSC hub site (%)	A 23-item assessment of fundamental inpatient stroke care (see primary outcome) at the CSC hub site. This data will serve to compare the delivery of inpatient stroke care via inpatient telestroke vs. stroke care delivered in person at the hub site.; An item is not scored if it is not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.	2 years retrospective data and 1 year prospective data after implementation of the inpatient telestroke service at the participating ASRH
Primary	Composite score of inpatient stroke care (%)	A 23-item global assessment of fundamental inpatient acute ischemic stroke care primarily informed by AHA guidelines/GWTG criteria comprising 4 categories: Diagnostic evaluation (10 items): neurologist evaluation, LDL, HgA1c, troponin, head CT or brain MRI, intracranial vascular imaging, cervical vascular imaging, EKG, telemetry, and outpatient prolonged cardiac monitoring.; Secondary prevention (6 items): antiplatelet, anticoagulation, statin, antihypertensives, diabetes management, and carotid revascularization.; Health screening & evaluation (4 items): swallow evaluation, cognitive assessment, depression screening, and rehabilitation evaluation.; Stroke education (3 items): tobacco cessation counseling, exercise/lifestyle counseling, and signs of stroke.; An item is not scored when not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.	1 year after implementation of the inpatient telestroke service
Secondary	Diagnostic Stroke Evaluation	A 10-item global assessment of inpatient diagnostic stroke evaluation as well as individual analysis of each item.; Diagnostic evaluation (10 items): neurologist evaluation, LDL, HgA1c, troponin, head CT or brain MRI, intracranial vascular imaging, cervical vascular imaging, EKG, telemetry, and outpatient prolonged cardiac monitoring.; An item is not scored when not indicated clinically (for example prolonged cardiac monitoring in a patient with known atrial fibrillation), therefore the composite scores will be reported and analyzed as percentages.	1 year after implementation of the inpatient telestroke service
Secondary	Secondary Stroke Prevention	A 6-item global assessment of secondary stroke prevention as well as individual analysis of each item.; Secondary stroke prevention (6 items): antiplatelet, anticoagulation, statin, antihypertensives, diabetes management, and carotid revascularization.; An item is not scored when not indicated clinically (for example deferring antiplatelet agents if a patient requires anticoagulation), therefore the composite scores will be reported and analyzed as percentages.	1 year after implementation of the inpatient telestroke service
Secondary	Health Screening & Evaluation	A 4-item global assessment of health screening and evaluation as well as individual analysis of each item.; Health screening & evaluation (4 items): swallow evaluation, cognitive assessment, depression screening, and rehabilitation evaluation.; An item is not scored when not indicated clinically, therefore the composite scores will be reported and analyzed as percentages.	1 year after implementation of the inpatient telestroke service
Secondary	Stroke Education	A 3-item global assessment of stroke education as well as individual analysis of each item.; Stroke education (3 items): tobacco cessation counseling, exercise/lifestyle counseling, and signs of stroke.; An item is not scored when not indicated clinically (for example tobacco cessation in a non-smoker), therefore the composite scores will be reported and analyzed as percentages.	1 year after implementation of the inpatient telestroke service
Secondary	Composite Stroke Recurrence	The composite rate of recurrent TIA, ischemic, or hemorrhagic stroke at 3 months and one year post-stroke admission.	Measured at 3 months and at 1 year after discharge