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Research and Innovation

Blue Sky Telehealth physicians are actively engaged in cutting-edge research in the study of neurology and telemedicine. Here’s a snapshot of the work our physicians do to enhance care not only for their patients, but the industry at large.


Telemedicine Quality and Outcomes in Stroke

Originally published November 2016 in Stroke by the American Heart Association.

A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association
The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists.
Endorsed by the American Telemedicine Association

Lawrence R. Wechsler, MD, FAHA, Chair; Bart M. Demaerschalk, MD, MSc, FRCPC, FAHA, Vice Chair; Lee H. Schwamm, MD, FAHA, Vice Chair; Opeolu M. Adeoye, MD, MS, FAHA; Heinrich J. Audebert, MD; Christopher V. Fanale, MD; David C. Hess, MD; Jennifer J. Majersik, MD, MS, FAHA; Karin V. Nystrom, APN; Mathew J. Reeves, BVSc, PhD, FAHA; Wayne D. Rosamond, PhD, MS, FAHA; Jeffrey A. Switzer, DO, MCTS; on behalf of the American Heart Association Stroke Council; Council on Epidemiology and Prevention; and Council on Quality of Care and Outcomes Research.

Purpose — TeleStroke is one of the most frequently used and rapidly expanding applications of telemedicine, delivering much-needed stroke expertise to hospitals and patients. This document reviews the current status of TeleStroke and suggests measures for ongoing quality and outcome monitoring to improve performance and to enhance delivery of care.

Methods — A literature search was undertaken to examine the current status of TeleStroke and relevant quality indicators. The members of the writing committee contributed to the review of specific quality and outcome measures with specific suggestions for metrics in TeleStroke networks. The drafts were circulated and revised by all committee members, and suggestions were discussed for consensus.

Results — Models of TeleStroke and the role of TeleStroke in stroke systems of care are reviewed. A brief description of the science of quality monitoring and prior experience in quality measures for stroke is provided. Process measures, outcomes, tissue-type plasminogen activator use, patient and provider satisfaction, and TeleStroke technology are reviewed, and suggestions are provided for quality metrics. Additional topics include licensing, credentialing, training, and documentation.

TeleStroke is one of the most successful applications of telemedicine, bringing the experience of stroke experts to hospitals lacking appropriate stroke expertise. The number and extent of TeleStroke networks continue to grow in the United States and throughout the world. As TeleStroke matures, monitoring practice quality and outcomes becomes essential to maintaining a high level of performance and ensuring that patients receive the full potential benefit of this advance. The purpose of this document is to review the current status of quality and outcomes in TeleStroke networks and to provide recommendations for TeleStroke providers and clients of these services to measure and improve performance and health outcomes.

Click here for the full study.


How a CT-Direct Protocol at an American Comprehensive Stroke Center Led to Door-to-Needle Times Less Than 30 Minutes

Originally published 2016 in The Neurohospitalist

Lisa M. Caputo, MA,Judd Jensen, MD, Michelle Whaley, MSN, Mark J. Kozlowski, MD, FACEP, Christopher V. Fanale, MD, Jeffrey C. Wagner, MD, Alessandro Orlando, MPH, and David Bar-Or, MD.

Background and Purpose - The safety and efficacy of intravenous tissue plasminogen activator (IV tPA) following acute ischemic stroke (AIS) is dependent on its timely administration. In 2014, our Comprehensive Stroke Center designed and implemented a computed tomography-Direct protocol to streamline the evaluation process of suspected patients with AIS, with the aim of reducing door-to-needle (DTN) times. The objectives of our study were to describe the protocol development and implementation process, and to compare DTN times and symptomatic intracranial hemorrhage (sICH) rates before and after protocol implementation.

Methods - Data were prospectively collected for patients with AIS receiving IV tPA between January 1, 2010, and May 31, 2015. The DTN times, examined as median times and time treatment windows, and sICH rates were compared pre- and postimplementation.

Results - Two hundred ninety-five patients were included in the study. After protocol implementation, median DTN times were significantly reduced (38 vs 28 minutes; P < .001). The distribution of patients treated in the three time treatment windows described below changed significantly, with an increase in patients with DTN times of 30 minutes or less, and a decrease in patients with DTN times 31 to 60 minutes and over 60 minutes (P < .001). There were two cases of sICH prior to implementation and one sICH case postimplementation.

Conclusions - The implementation of a protocol that streamlined the processing of suspected patients with AIS significantly reduced DTN time without negatively impacting patient safety.

An untreated acute ischemic stroke (AIS) may result in the loss of 1.9 million neurons per minute.1 Intravenous tissue plasminogen activator (IV tPA) is an effective treatment to dissolve clots and restore blood flow in patients with AIS, but its effectiveness is dependent on timely administration.2 A well coordinated evaluation involving multiple departments is required from the time of patient arrival through IV tPA administration. This evaluation must include confirmation of last known normal medical history and examination, National Institutes of Health Stroke Scale (NIHSS) determination, a head computed tomography (CT) scan, and an IV tPA preparation. The American Heart Association and American Stroke Association recommend the time between emergency department (ED) arrival and administration of IV tPA, known as door-to-needle (DTN) time, to be less than 60 minutes to optimize the benefits of the drug. However, less than one-third of patients with AIS in the United States were treated within this time window between 2003 and 2009.4 In 2014, our Comprehensive Stroke Center implemented a protocol to increase the efficiency of the initial evaluation process for patients with AIS, with an aim to reduce DTN times. This report describes our protocol development and implementation process and compares DTN times and symptomatic intracranial hemorrhage (sICH) rates pre and post protocol implementation.

Click here for the full study.


Additional Selected Research by Our Physicians

Research/Clinical Trials

  • The Impact of Left versus Right Sided Strokes on Intracerebral Hemorrhage. Bartt R, Leonard J, Salottolo K, Nieberlein A, Bar-Or D. Poster presentation, American Academy of Neurology 70th Annual Meeting, April 21-27 2018, Los Angeles, CA.
  • Timing Of Anticoagulation In Patients With Cerebral Venous Thrombosis Requiring Neurosurgery: Case Series. Bartt R, Salottolo K, McCarthy K, van Vliet R, Nieberlein A, Jensen J, Bar-Or D. Poster presentation, American Academy of Neurology 70th Annual Meeting, April 21-27 2018, Los Angeles, CA.
  • Increased Cysteinylated Albumin is Associated with More Favorable Outcomes in Ischemic Stroke Patients, A Reflection of Collateral Circulation? Bartt R, Leonard J, Bar-Or R, Rael LT, Bar-Or D. Poster presentation, American Academy of Neurology, Boston MA, April 2017.
  • Aspirin use is associated with decreased initial stroke severity in patients with acute ischemic stroke: Pilot study. Jensen J, Leonard J, Bar-Or R, Rael LT, Bartt R, Wagner J, Bar-Or D. Poster presentation, American Academy of Neurology, Boston MA, April 2017.
  • Improving Neurologist Responsiveness For TeleStroke Consultations: We Do Better! Wagner J, Salottolo K, Fanale C, Jensen J, Bar-Or D. Poster presentation, American Academy of Neurology, Boston MA, April 2017.
  • Outcomes after Endovascular Therapy in a Population with Mild Acute Ischemic Stroke: A 6.5 Year Observational Cohort Study at a High-Volume Comprehensive Stroke Center. Frei D, Orlando A, Bellon R, Wagner J, Fanale C, Jensen J, Bartt R, van Vliet R, McCarthy K, Bar-Or D. Poster presentation, American Academy of Neurology, Boston MA, April 2017.
  • Outcomes after Endovascular Therapy in a Population with Mild Acute Ischemic Stroke and Large Vessel Occlusion: Does Treatment Help? Frei D, Orlando A, Bellon R, Wagner J, Fanale C, Jensen J, Bartt R, van Vliet R, McCarthy K, Bar-Or D.Poster presentation, American Academy of Neurology, Boston MA, April 2017.
  • Intravenous Tissue Plasminogen Activator for Patients with Mild and Rapidly Improving Ischemic Strokes and Large Vessel Occlusions: Examining In-hospital Outcomes. Wagner J, McGraw C, McCarthy K, Bartt R, Jensen J, Orlando A, Bar-Or D. Poster presentation, American Academy of Neurology, Boston MA, April 2017.
  • Improving Neurologist Responsiveness For TeleStroke Consultations: We Do Better! Wagner J, Salottolo K, Fanale C, Jensen J, Bar-Or D. Poster presentation, International Stroke Conference, Houston TX, February 2017.
  • Outcomes after Endovascular Therapy in a Population with Mild Acute Ischemic Stroke: A 6.5 Year Observational Cohort Study at a High-Volume Comprehensive Stroke Center. Frei D, Orlando A, Bellon R, Wagner J, Fanale C, Jensen J, Bartt R, van Vliet R, McCarthy K, Bar-Or D. Poster presentation, International Stroke Conference, Houston TX, February 2017.
  • Outcomes after Endovascular Therapy in a Population with Mild Acute Ischemic Stroke and Large Vessel Occlusion: Does Treatment Help? Frei D, Orlando A, Bellon R, Wagner J, Fanale C, Jensen J, Bartt R, van Vliet R, McCarthy K, Bar-Or D. Poster presentation, International Stroke Conference, Houston TX, February 2017.
  • Intravenous Tissue Plasminogen Activator for Patients with Mild and Rapidly Improving Ischemic Strokes and Large Vessel Occlusions: Examining In-hospital Outcomes. Wagner J, McGraw C, McCarthy K, Bartt R, Jensen J, Orlando A, Bar-Or D. Poster presentation, International Stroke Conference, Houston TX, February 2017.
  • Plasma Of Subarachnoid Hemorrhage And Reversible Cerebral Vasoconstriction Syndrome Patients Increases Brain Endothelial Permeability In Vitro. Gregory Thomas, BS; Leonard Rael, MS; Jan Leonard, MSPH; Matthew Carrick, MD; Denetta S. Slone, MD; Charles W. Mains, MD; Jeffrey Wagner, MD; David Bar-Or, MD. Poster presentation, AAST, Waikoloa, HI, September 2016.
  • Symptomatic Intracranial Hemorrhage Rates and Intravenous Tissue Plasminogen Activator Treatment Time Windows: Does Treatment Window Make a Difference? Wagner J, Orlando A, Fanale C, Whaley M, McCarthy K, Jensen J, Bar-Or D. Poster presentation, American Association of Neurology, Vancouver, BC, April 2016.
  • Intraarterial Treatment for Acute Ischemic Stroke: Analysis of Outcomes of Dissection vs. Non-Dissection Mechanism in 445 patients. Jensen J, Salottolo K, McCarthy K, Loy D, Frei D, Wagner J, Whaley M, Bar-Or D.Poster presentation, American Association of Neurology, Vancouver, BC, April 2016.
  • Intraarterial Treatment for Acute Ischemic Stroke due to Dissection: Retrospective Series of 24 Cases. Jensen J, Salottolo K, McCarthy K, Frei D, Loy D, Wagner J, Whaley M, Bar-Or D.Poster presentation, American Association of Neurology, Vancouver, BC, April 2016.
  • Pre-mixing tPA: Moving Past Gestalt. McCarthy K, Caputo LM, Whaley M, Fanale C, Bar-Or D.Poster presentation, American Association of Neurology, Vancouver, BC, April 2016.
  • Impact of Transfer Status into a Comprehensive Stroke Center on Outcomes among Intra-Arterial Therapy Patients. Frei D, Leonard J, Jensen J, Whaley M, McCarthy K, Wagner J, Bar-Or D.Poster presentation, American Association of Neurology, Vancouver, BC, April 2016.
  • The Impact of Marijuana Legalization on Reversible Cerebral Vasoconstriction Syndrome. Wagner J, Leonard J, Jensen J, Jensen A, Farrell L, McCarthy K, Bar-Or D. Poster presentation, American Association of Neurology, Vancouver, BC, April 2016.
  • Symptomatic Intracranial Hemorrhage Rates and Intravenous Tissue Plasminogen Activator Treatment Time Windows: Does Treatment Window Make a Difference? Wagner J, Orlando A, Fanale C, Whaley M, McCarthy K, Jensen J, Bar-Or D.Poster presentation, International Stroke Conference, Los Angeles, CA, February 2016.
  • Intraarterial Treatment for Acute Ischemic Stroke due to Dissection: Retrospective Series of 24 Cases. Jensen J, Salottolo K, McCarthy K, Frei D, Loy D, Wagner J, Whaley M, Bar-Or D.Poster presentation, International Stroke Conference, Los Angeles, CA, February 2016.
  • Intraarterial Treatment for Acute Ischemic Stroke: Analysis of Outcomes of Dissection vs. Non Dissection Mechanism in 445 patients. Jensen J, Salottolo K, McCarthy L, Loy D, Frei D, Wagner J, Whaley M, Bar-Or D.Poster presentation, International Stroke Conference, Los Angeles, CA, February 2016.
  • Pre-mixing tPA: Moving Past Gestalt. McCarthy K, Caputo LM, Whaley M, Fanale C, Bar-Or D.Poster presentation, International Stroke Conference, Los Angeles, CA, February 2016.
  • Impact of Transfer Status into a Comprehensive Stroke Center on Outcomes among Intra-Arterial Therapy Patients. Frei D, Leonard J, Jensen J, Whaley M, McCarthy K, Wagner J, Bar-Or D.Poster presentation, International Stroke Conference, Los Angeles, CA, February 2016.
  • A door-to-needle time under 30 minutes can be achieved and can improve functional outcomes. Whaley M, Caputo L, Kozlowski M, Fanale C, Wagner J, Bar-Or D. American Academy of Neurology; April 2015, Washington, DC.
  • The Presence of an Advanced Practice Nurse Stroke Coordinator Decreases Door-to-Needle Times. Whaley M, Caputo L, Wagner J. American Academy of Neurology; April 2015, Washington, DC.
  • A Four-Year Experience of Symptomatic Intracranial Hemorrhage Rate Following Intravenous Tissue Plasminogen Activator at a Comprehensive Stroke Center. Wagner JC, Orlando A, Fanale CV, Whaley M, McCarthy KL, Bar-Or D. American Academy of Neurology; April 2015, Washington, DC.
  • Intraarterial Thrombolysis And Endovascular Treatment is Safe and Effective In Patients With Ischemic Stroke Due To Dissection. Jensen J, Wagner JC, Salottolo K, Loy D, Bar-Or D. American Academy of Neurology; April 2015, Washington, DC.
  • A Novel Method for Measuring Oxidative Stress in Patients with Stroke Symptoms. Wagner JC, Salottolo K, Fanale C, Whaley M, McCarthy K, Bar-Or D. American Academy of Neurology; April 2015, Washington, DC.
  • Intra-Arterial Therapy is Safe and Effective in Patients Aged ≥ 80. Frei D, Leonard J, Salottolo K, Fanale C, Wagner JC, Whaley M, McCarthy K, Loy D, Bar-Or D. American Academy of Neurology; April 2015, Washington, DC.
  • A Four-Year Experience of Symptomatic Intracranial Hemorrhage Rate Following Intravenous Tissue Plasminogen Activator at a Comprehensive Stroke Center. Wagner JC, Orlando A, Fanale C, Whaley M, McCarthy K, Bar-Or D. International Stroke Conference, February 2015; Nashville, TN.
  • A Novel Method for Measuring Oxidative Stress in Patients with Stroke Symptoms. Wagner JC, Salottolo K, Fanale C, Whaley M, McCarthy K, Bar-Or D. International Stroke Conference, February 2015; Nashville, TN.
  • Intra-Arterial therapy is safe and effective in patients aged ≥80. Frei D, Salottolo K, Njau G, Fanale C, Wagner JC, Whaley M, McCarthy K, Loy D, Bar-Or D. International Stroke Conference, February 2015; Nashville, TN.
  • A door-to-needle time under 30 minutes can be achieved and can improve functional outcomes. Whaley M, Caputo LM, Kozlowski M, Fanale C, Wagner JC, Bar-Or D. International Stroke Conference, February 2015; Nashville, TN.
  • The presence of an advanced practice nurse stroke coordinator decreases door-to-needle times. Whaley M, Caputo LM, Wagner JC. International Stroke Conference, February 2015; Nashville, TN.
  • Telemedicine Quality and Outcomes in Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association.
    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.
    Stroke. 2017 Jan;48(1):e3-e25.
  • Prospective, open-label safety study of intravenous recombinant tissue plasminogen activator in wake-up stroke. Barreto AD, Fanale CV, Alexandrov AV, Gaffney KC, Vahidy FS, Nguyen CB, Sarraj A, Rahbar M, Grotta JC, Savitz SI; Wake-Up Stroke Investigators. Ann Neurol. 2016 Aug;80(2):211-8.
  • TeleStroke network business model strategies. Fanale CV, Demaerschalk BM. J Stroke Cerebrovasc Dis. 2012 Oct;21(7):530-4.
  • Real-time cerebral angiography: sensitivity of a new contrast-specific ultrasound technique. Hölscher T, Sattin JA, Raman R, Wilkening W, Fanale CV, Olson SE, Mattrey RF, Lyden PD. AJNR Am J Neuroradiol. 2007 Apr;28(4):635-9.
  • Secondary Prevention of Small, Subcortical Strokes (SPS3) 2009- closed to enrollment
  • ENGAGE AF- TIMI 48: Study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillation with resent stroke. 2010- closed to enrollment
  • IMS III: A phase III, randomized, multi-center, open label trial to assess if intra-venous (IV) and intra-arterial (lA) approach to recanalization is superior to standard IV rt-PA (Activase®) alone when initiated within three hours of acute ischemic stroke onset. 2007 – Present
  • Advancing TeleStroke Care a Prospective Observational Study 2010- Present
  • POINT – Platelet-Oriented Inhibition in New TIA and minor ischemic stroke 2010 - Present
  • CONTROL: Clinical Testing Of the Nasogastric Tube TempeRature SensOr for use with the Arctic Sun to Limit Temperature Variation, Medivance, 06/2011.
  • The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke 2011 – 2012.
  • DIAS-4, A randomized, double-blind, parallel-group placebo-controlled, phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke 2011- Present
  • StELLAR -Prospective, Double-Blind, Sham-Controlled, Randomized, Multi-Center Safety and Preliminary Efficacy Study of IV rt-PA Versus IV rt-P A plus Transcranial Laser Therapy (TL T) 2011- Present
  • The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke 2011 – Present
  • S-STREAM: A Multicenter Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement Scale in Subjects Obtained Between 24 and 48 Hours of a Nonhemorrhagic Ischemic Stroke 2012 – Present
  • Safety of Intravenous Thrombolysis for Wake-up Stroke 2012 – Present
  • ESCAPE trail: Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke, 2013-present
  • RESPECT-ESUS trial of anticoagulation for embolic stroke, 2014-present
  • ATACH-II Antihypertensive Treatment of Cerebral Hemorrhage, 2013 – 2016.
  • Acute Stroke Or Transient IsChemic Attack TReated with Aspirin or Tigagrelor And Patient OutcomES (SOCRATES), 2014 – 2016
  • A Week in the Neurocritical Care Unit: Point Prevalance Observational Study in Neurocritical Care. (PRINCE) study, 2015.
  • Impact of Fever Prevention in Brain Injured Patients (INTREPID), 2017 – present.

Publications

  • Leonard J, Frei D, Salottolo K, Fanale CV, Wagner JC, Whaley M, McCarthy K, Bellon RJ, Loy D, Bar-Or D. Age ≥80 Years Is Not a Contraindication for Intra-Arterial Therapy after Ischemic Stroke. Cerebrovasc Dis. 2015;40(3-4):121-8.
  • Frei D, McGraw C, McCarthy K, Whaley M, Bellon RJ, Loy D, Wagner J, Orlando A, Bar-Or D. A standardized neurointerventional thrombectomy protocol leads to faster recanalization times. J Neurointerv Surg. 2017 Nov;9(11):1035-1040
  • Orlando A, Wagner JC, Fanale CV, Whaley M, McCarthy KL, Bar-Or D. A Four-Year Experience of Symptomatic Intracranial Hemorrhage Following Intravenous Tissue Plasminogen Activator at a Comprehensive Stroke Center. J Stroke Cerebrovasc Dis. 2016 Apr;25(4):969-76.
  • Salottolo K, Wagner J, Frei D, Loy D, Bellon R, McCarthy K, Jensen J, Fanale C, Bar-Or D. Epidemiology, Endovascular Treatment, And Prognosis Of Cerebral Venous Thrombosis: US Center Study of 152 Patients. Journal of the American Heart Association, 2017 Jun 13;6(6).
  • Caputo MA, Jensen J, Whaley M, Kozlowski MJ, Fanale CV, Wagner JC, Orlando A, Bar-Or D. How a “CT-Direct” protocol at an American Comprehensive Stroke Center led to door-to-needle times less than 30 minutes. The Neurohospitalist. 2017 Apr;7(2):70-73.
  • Judd Jensen,Jan Leonard, Kristin Salottolo,Kathryn McCarthy,Jeffrey Wagner, David Bar-Or. The Epidemiology of Reversible Cerebral Vasoconstriction Syndrome in Patients at a Colorado Comprehensive Stroke Center. The Journal of Vascular and Interventional Neurology. 2018 Apr.10(1) in press
  • Salottolo KM, Fanale CV, Leonard KA, Frei DF, Bar-Or D. Multimodal imaging does not delay intravenous thrombolytic therapy in acute stroke. AJNR Am J Neuroradiol. 2011 May;32(5):864-8.
  • Jensen J, Salottolo K, Frei D, Loy D, McCarthy K, Wagner J, Whaley M, Bellon R, Bar-Or D. Comprehensive analysis of intra-arterial treatment for acute ischemic stroke due to cervical artery dissection. J Neurointerv Surg. 2017 Jul;9(7):654-658.
  • Chang, I. Structural Issues in Neurohospitalist Medicine. Chapter 17, Neurohospitalist Medicine, Cambridge Medical Press, Oct. 2010.
  • Chang, I. Neurohospitalists; An Emerging Subspecialty. Colorado Neurological Institute (CNI) Online Review. January 2011.
  • J Claassen, Chang, I & Bleck, T. “Seizures and Epilepsy”, Book Chapter in The Practice of Neurocritical Care. Neurocritical Care Society 2015.
  • Bennett A, Wilder M, McNally JS, Wold J, Stoddard G, Majersik J, Ansari S, de Havenon A. Increased Blood Pressure Variability After Endovascular Thrombectomy for Acute Stroke is Associated with Worse Clinical Outcome. J. Neurointervent Surg. 2018; 0: 1-6.