Final report of the Stroke Trauma Senate Study Committee : SR 412

GEORGIA STATE SENATE
SENATE RESEARCH OFFICE
204 Coverde// Legislative Office Building 1 404. 656.0015 18 Capitol Square SW Atlanta GA30334

ELIZABETH HOLCOMB DIRECTOR
ALEX AZARIAN DEPUTY DIRECTOR

FINAL REPORT OF THE STROKE TRAUMA SENATE STUDY COMMITIEE SR 412
Committee Members
Senator John Kennedy Chair District 18
Senator Dean Burke District 11
Senator Renee Unterman District 45
Senator Ben Watson District 1
Christopher Hendry MD Navicent Chief Medical Officer
David Hess MD Dean of the Medical College of Georgia and Executive Vice President for Medical Affairs and
Integration at Augusta University
Joe Sam Robinson Jr. MD Neurosurgeon Navicent Medical Center
Kiva Schindler RN CRCC Research Nurse Coordinator at Emory University Department of Neurology

Prepared by the Senate Resea rch Office 2017

TABLE OF CONTENTS
Study Committee Focus Creation and Duties........................................3 Background ........................................................................4 Meeting Testimony .........................................................................7 Committee Findings .....................................................................9 Committee Recommendations ............................................. 12 Signature Page ......................................................................14
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STUDY COMMITTEE FOCUS CREATION & DUTIES
The Stroke Trauma Senate Study Committee (Committee) was created with the adoption of Senate Resolution 412 during the 2017 Legislative Session. The following individuals were appointed by the President of Senate to serve as members of this Committee
Senator John Kennedy of the 18th- Chair Senator Dean Burke of the 11th Senator Renee Unterman ofthe 45th Senator Ben Watson of the 1st Christopher Hendry MD Navicent Chief Medical Officer David Hess MD Dean of the Medical College of Georgia at Augusta University Joe Sam Robinson MD Neurosurgeon Navicent Medical Center Kiva Schindler RN CRCC Research Nurse Coordinator at Emory University Department of
Neurology The Committee was tasked with undertaking a study of stroke trauma in Georgia. The following legislative staff members were assigned to this Committee lnes Owens of the Senate Press Office Donavan Eason and Elizabeth Holcomb of the Senate Research Office and Macy McFall Legislative Assistant to Senator Kennedy.
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BACKGROUND
In 2000 members of the Brain Attack Coalition1 published recommendations for the establishment of prima ry stroke centers and in 2005 t hey published recommendat ions for t he establishment of comprehensive stro ke centers.2 During that same time several states deve loped their own certification programs with the goal of improving stroke care and drawing stroke patients to capable centers. Legislation also provided for emergency medica l services (EMS) to route ambulances directly to certified stroke centers so that standard acute stroke therapies could be delivered mo re reliably and rapidly. These efforts have increased t he number of stroke ce nters across t he count ry and consequent ly en hanced access to acute stroke care.3
The Components of Stroke System of Care

Pre-Event

Prlmordoal Provonton& Community
Educ ol ion

Primary P r o v c n 11on
--- &
Outpallenl Care

t - - ---

-

Event

PostEvent

l

Ongolng

.

EMS

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Acute CaN

t-

Rehabilitofion & Roc ovory

I

i
I I Telemecllc i ne

I

1 i Sec ondllry PNVOnllon

I I for Stroke

Georgia s Stroke Center Network and Classifications
Recognizing the benefits of stroke center certification the Georgia General Assembly developed its own program in 2008 to identify certified stroke centers th roughout the state set t ing specific patient care and support service criteria t hat prospective stroke centers must meet in orde r t o ensu re stroke patients received safe and effective care.4 To attract participation the state also pledged financial support (subject to appropriation) to acute care hospitals that obtained certification .5

1 "The Brain Attack Coalition is a group of professional voluntary and governmental organizations dedicated to setting direction advancing knowledge and communicating the best practices to prevent and treat stroke ." The group is convened by the National Institutes of Health National Institute of Neurological Disorders and Stroke and Co-Chaired by Michael D. Walker M .D. and Mark Alberts M.D. About Us BRAINAnACK COALITION https //www.brainattackcoalition.org/about.html. 2 Linda J. Schieb et al. Mapping Primary and Comprehensive Stroke Centers by Certification Organization CIRCULATION CARDIOVASCULAR QUALITY AND OUTCOMES (Oct. 29 2015) http //circoutcomes.ahajournals.org/content/8/6 suppl 3/S193. 3 Ken Uchino et al. Stroke Legislation Impacts Distribution of Certified Stroke Centers in the United States STROKE (Jun . 18 2015) http //stroke.ahajournals.org/content/strokeaha/early/2015/06/18/STROKEAHA.114.008007.full.pdf. 4 Coverdeii-Murphy Act S.B. 549 2 (2008) (codified at O.C.G .A. 31-11-110 et seq.) http //www.legis.ga.gov/Legislation/enUS/display/20072008/SB/549. 5 Coverdeii-Murphy Act S.B. 549 2 (2008) (codified at O.C.G.A. 31-11-114) http //www.legis.ga.gov/Legislation/enUS/display/20072008/SB/549.
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Georgia Coverdell Acut e Stroke Registry Participating Hospitals (n 65) November 2016
Legend
0 Comprehensive SlrOke Center
Primary Slroke Center
* Remote Treatmem Stroke Center

Hospitals seeking stroke center certification must apply to the Department of Public Health (DPH). Three stroke center classifications exist
1) Comprehensive (CSC)6 2) Primary (PSC) 3) Remote (RSC)

Prior to obtaining any certification as a esc or PSC
hospitals must provide adequate documentation of the hospital s valid certification as a CSC or PSC by a national healthcare accreditation body recognized by DPH.7

RSCs must be certified as an acute stroke-ready hospital by a national health accreditation body recognized by DPH or through an application process determined by the DPH.8

include at a minimum

125 251/.iles

CSCs and PSCs are also encouraged to coordinate appropriate access to care for acute stroke patients through agreement with RSCs.9 The coordinating stroke care agreement must be in writing and

1) transfer agreements for the transport and acceptance of all stroke patients seen by the RSC for stroke treatment therapies which the RSC is not capable of providing and
2) Communication criteria and protocols with the RSC.10

Data Gathering by the Georgia Coverde/1 Acute Stroke Registry
Hospitals certified as a stroke center by DPH are required to submit data to the Georgia Coverdell Acute Stroke Registry (GCASR).U GCASR currently has 65 participating acute care hospitals of which 44 are

6 The classification for comprehensive stroke centers was added in 2016 with the passage of H.B. 853 http //www.legis.ga.gov/Legislation/en-US/display/20152016/hB/853. Yet the classification for comprehensive stroke centers has existed for some time. In 2007 Sen. Don Thomas and Rep. Don Parsons co-chaired the Joint Study Committee on State Stroke System of Care. The American Heart Association presented model legislation designating three levels of stroke care "(1) primary stroke centers which would require a hospital to be certified by the Joint Commission on Accreditation of Health Care Organizations as a primary stroke center or at least meet certain criteria such as constantly maintaining an acute stroke team (2) comprehensive stroke centers which would be awarded to hospitals t hat exceed the requirements of a primary stroke center .. . and (3) support stroke centers a designation that would be bestowed upon rural faci lities that offer timely access to a limited number of stroke care services and that coordinate with comprehensive and primary stroke centers." The Study Committee Report is found on the Senate s website http //www.senate.ga .gov/sro/Documents/StudyCommRpts/07JtStrokeRpt.pdf. 7 O.C.G.A. 31-11-113(a). 8 /d. 113(b). 9 ld. 113(d). 10 /d.
11 /d. 116(a). GCASR is named in honor of the late Senator Paul Coverdell of Georgia who died of a massive stroke in 2000. It is funded by the Centers for Disease Control and Prevention (CDC) as part of its national counterpart-the Paul Coverdell National Acute Stroke Registry https //www.cdc.gov/dhdsp/programs/stroke registry.htm. GCASR is a partnership between DPH Epidemiology DPH Office of EMS Emory University the American Heart Association the American Stroke Association the
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comprehensive or primary stroke centers and seven are remote stroke treatment centers. Georgia EMS provides data on the number of subjects evaluated and transported to acute care facilities with a presumptive diagnosis of acute strokeY
Data collected by GCASR provides DPH with assurances that patients are receiving the appropriate level of care and treatment at each level of stroke center in the state-both in the pre-hospital and in-hospital delivery setting.B The required data includes but is not limited to the following
(a) Date of admission and discharge (b) Patient disposition at discharge (c) Patient identifier currently known as "Georgia LONGID " that consists of elements defined by DPH (d) Patient age gender and race (e) Location where the stroke occurred (f) Patient arrival mode (g) Patient s past medical and medication history h) Clinical diagnosis of type of stroke or transient ischemic attack (i) The National Institutes of Health stroke scale score j) Serum low density lipoprotein level (k) Whether stroke symptoms were resolved at time of presentation (I) Earliest time patient placed on comfort measure only (m) Whether patient was admitted for elective carotid intervention (n) Whether patient was participating in a stroke related clinical trial (o) Whether in-hospital treatment with intravenous or intra-arterial thrombotic or mechanical clot
removal antithrombotic or venous thromboembolism prophylaxis was provided or reason for not providing each treatment (p) Date and time of last known well visit hospital arrival imaging and treatment administration (q) Whether dysphagia screen had been completed (r) Whether treatment at discharge with antithrombotic anticoagulant or statin (lipid-lowering medication) was provided or reason for not providing each treatment (s) Whether smoking cessation advice or counseling was provided (t) Whether stroke education was provided (u) Whether rehabilitation services was provided (v) Modified Rankin Scale score at discharge14
Georgia Medical Care Foundation the Georgia Hospital Association CDC and the participating hospitals rehabilitation centers and EMS agencies in Georgia . 12 Information regarding scope of practice for EMS personnel and a stroke thrombolytic checklist can be found the DPH website. EMS Rules and Protocols GEORGIA DEPARTMENT OF PUBLIC HEALTH https //dph.georgia.gov/ems-rules-and-protocols. 13 GA. COMP. R. & REGS. 511-9-2-.04(d). 141d.
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MEETING TESTIMONY
This section provides a brief summary of topics covered at each meeting including the names and affiliations of individuals who were asked to provide testimony to the Committee. Although testimony has been condensed to ensure the report could be timely submitted copies of all presentations and materials submitted to the Committee are kept on file in the Senate Research Office.
Meeting 1- September 6 2017 The first meeting was held at the Navicent Medical Center in Macon Georgia on September 6 2017. Senator Kennedy provided opening remarks and introductions. Dr. Christopher Hendry Navicent Chief Medical Officer and member of the Committee provided a brief welcome and shared that Navicent is on a path to become a comprehensive stroke center with the help of Dr. Arthur Grigorian. Dr. Jean Sumner Dean of Mercer School of Medicine also welcomed the Committee and noted that patient care was once very much driven by the where the patient ended up in terms of care location and facility.
Before hearing testimony the Committee received an overview of Certified Stroke Centers in Georgia from Donavan Eason of the Senate Research Office.15
Testimony was provided by the following individuals and agencies Georgia Department of Public Health
o Review of 2016 Stroke Data o R. Keith Wages Director Georgia Office of EMS and Trauma o Ernie Doss Deputy Director Georgia Office of EMS and Trauma Dr. Arthur Grigorian Dr. Dennis Ashley Trauma Director at MCG Chair of the Georgia Trauma Commission
The Committee requested that DPH return to provide testimony at Meeting 2 on the recent implementation of a statewide system of Emergency Cardiac Care Centers created by the passage of Senate Bill102 in 2017.
Meeting 2- November 15 2017 Meeting 2 was held on November 15 2017 at the Capitol in Atlanta Georgia. Continuing the discussion from Meeting 1 the Committee heard testimony from the following individuals
"Stroke Care in Georgia Grady s Marcus Stroke and Neuroscience Center the Marcus Stroke Network and the Coverdell Murphy Act and Acute Stroke Registry At Work" o Michael Frankel MD- Grady Memorial Hospital Professor and Director of Vascular Neurology Dept. of Neurology Director Georgia StrokeNet o Karen B. Seagraves MS MPH RN ANP-BC ACNS-BC FAHA Executive Director Marcus Stroke and Neuroscience Center Grady Health System
Cardiac Care Presentation (Implementation of SB 102) o David Newton DrPH(c) MPH NRP Cardiac Care Registrar Georgia Office of EMS and Trauma Department of Public Health

15 See Background information supra at Page 4.

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Meeting 3- December 21 2017 The Committee met for a final time at the Capitol in Atlanta Georgia to discuss findings recommendations and adopt a final report. Senators Kennedy and Unterman were present in Room 450 of the Capitol Senator Burke Dr. Robinson Dr. Hendry and Ms. Schindler attended the meeting via teleconference. The vote to adopt the final report was unanimous.
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COMMITTEE FINDINGS
DAWN Trial The findings of the DAWN trial were published in the New England Journal of Medicine (NEJM) in November 2017. The clinical trial shows a major breakthrough in stroke care extending a 6-hour treatment window to 24 hours.16
The DAWN trial (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo) results of which are now reported in the Journal investigated the efficacy and safety of endovascular thrombectomy that is performed 6 to 24 hours after the onset of stroke. The trial was halted on the basis of results of a prespecified interim analysis which suggested a high probability of success. The trial included patients with occlusion of a large cerebral vessel who presented between 6 and 24 hours after the onset of stroke. Patients underwent successful thrombectomy even though the usually accepted window for stroke treatment is within 6 hours after the first observation of symptoms. Furthermore approximately 60% of the patients had had their first stroke symptoms when they woke up which meant that the time of stroke onset was not known this circumstance is currently a contraindication to endovascular or thrombolytic treatment. However patients in the DAWN trial were selected specifically because they had a region of brain that was poorly perfused but not yet infarcted. In essence the usual 6-hour time window for stroke treatment was replaced with a "tissue window."17
Georgia Stroke Centers At the first meeting DPH provided Figure 1 (below Page 11) explaining that there are 42 designated primary stroke centers in Georgia. In addition 67 hospitals participate in the Coverdell Acute Stroke Registry with some of these hospitals not being certified as stroke centers. For remote stroke engaging the rural hospitals in areas where coverage is not as available is a significant component to bridging the care gap.
Testimony from DPH highlighted a pilot program that identified key ambulance services around the state paired those with primary stroke centers and attempted to integrate the care. EMS was asked to assess five things
1. Assess the patient right 2. Pick the right hospital 3. Call the hospital in advance to inform the facility you are en route 4. Provide the hospital good information upon arrival and 5. Document the call and submit the data.
Hospitals were asked to provide feedback to the EMS community as to whether the assessment was correct and let them know how the patient responded to treatment. Reports of positive feedback that commended EMS for making good choices resulted in an increase of good choices in the future. This
16 See http //www.nejm.org/doi/fuii/10.1056/NEJMoa1706442 t article. Nogueira RG Jadhav A Haussen DC Bonafe A Budzik RF ... Jovin TG et al. Thrombectomy 6 to 24 hours after Stroke with Mismatch between Deficit and Infarct. NEJM November 11 2017. 17 /d.
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example was provided to stress how to approach and implement a.system and how strengthening one system in turn strengthens systems across the board. Improvements in treatment window time equate to better outcomes. For stroke time is brain for cardiovascular and heart episodes time is muscle and for trauma patients time is salvation.
The Georgia Stroke Professionals Alliance (GSPA) has embraced collaboration and Georgia s stroke system journey was described to the Committee and personifying the concept of teamwork. Dr. Grigorian emphasized that there is an enormous difference between comprehensive and primary stroke centers adding that comprehensive stroke centers are the only centers capable of doing interventional treatment. This position aligns with that of the DAWN study.
Georgia Stroke Centers
CompJehe e
We Protf d liv .
Figure 1 Slide from DPH s Presentation at Meeting 1
Data Reporting Standards Mr. Doss of DPH provided testimony on GEMSIS Georgia s statewide EMS data system. GEMSIS is a webbased central data repository that provides a statewide data standard that is applicable to all service licensees. If needed GEMSIS allows service providers to create data using its analytical and reporting features. DPH is currently migrating from the original GEMSIS to a newer data standard called GEMSIS Elite. They have developed five stroke measures that will be based on the new EMS reporting. As EMS transports stroke patients they are able to view performance measures such as whether blood glucose was documented with a provider s primary impression of the patient presenting with TIA. Documentation like this is not available in the older GEMSIS system. Other solutions that are being worked on include connecting the GEMSIS data set with the trauma registry as well as the stroke registry aiming for linkage to run reports from a statewide perspective without having to conduct manual imports. After discussion at Meeting 1 the Committee agreed that algorithms help the patient reach the right treatment means center. Although Emory uses a stroke algorithm called FAST-ED there is no state-mandated algorithm.
Overview Statewide System of Emergency Cardiac Care Centers (SB 102) Sponsored by Senator Miller of the 49th during the 2017 Senate Bill102 establishes the Office of Cardiac Care (office) within the Department of Public Health (DPH). This office will designate hospitals that meet
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the criteria to become emergency cardiac care centers. These centers will receive a designation of Level I II or Ill based on the following criteria.
Levell - must have all of the following
Cardiac catheterization and angioplasty facilities available at all times On-site cardiothoracic surgery capability available at all times Protocols established for therapeutic hypothermia for out-of-hospital cardiac arrest patients Ability to implant percutaneous left ventricular assist devices for support of hemodynamically
unstable patients experiencing out-of-hospital cardiac arrest or heart attacks Neurologic protocols to measure functional status at discharge and Ability to implant automatic implantable cardioverter defibrillators.
Level II - must have all of the following
Cardiac catheterization and angioplasty facilities available at all times Protocols established for therapeutic hypothermia for out-of-hospital cardiac arrest patients Neurologic protocols to measure functional status at discharge and Transfer plan to a Level I facility for those who need left ventricular assist devices or cardiothoracic
surgery.
Level Ill - must have all of the following
Protocols established for therapeutic hypothermia for out-of-hospital cardiac arrest patients and Transfer plan to a Levell or Level II facility.
DPH has the authority to establish additional levels as necessary. The office must establish a data reporting system on out-of-hospital cardiac arrest patients and all heart attack patients establish protocols on triage assessment treatment and transport of cardiac patients for emergency medical services providers and provide a list of emergency cardiac care centers to each licensed emergency medical services provider in the state maintain a copy at the office and publish this list on their website by June 1 2018.
With the enactment and implementation of SB 102 Georgia is one of three states with a statewide system of designated cardiac care centers joining Washington State and Arizona.
At Meeting 2 the Committee discussed the 2007 Joint Study Committee on State Stroke System of Care co-chaired by Sen . Don Thomas and Rep . Don Parsons.18

1s See FN 6 at Page 6.

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COMMITTEE RECOMMENDATIONS
The Committee agrees that the economic issues of stroke care deserve careful consideration and should continue to be examined . An understanding of the costs and efficiencies stemming from investments in prevention as well i3S after-care is key. Emergency transport through helicopters and ambulances should be explored in addition to other funding mechanisms such as grant programs on the state and federal levels that could improve outcomes and the delivery of stroke trauma care in Georgia.
Georgia should embrace the findings of the DAWN Trial and strive to create a health care delivery system where patients should be taken to the closest available institution for a CT and TPA within 6 hours of the acute event. If this is not possible those patients with a stroke onset between 6 to 24 hours should go to a comprehensive stroke center. Regardless of treatment location statistics should be collected on all acute stroke patients up to a 24-hour period.
The Committee encourages the Joint Commission s standing committees advisory groups accredited organizations and professional associations specializing in acute care to conference together to examine efficiencies of scale as it relates to the standards development process.
The Committee supports the establishment of a Georgia Stroke Commission which would work in concert with the Georgia Coverdell Acute Registry. The resources in place at Grady Health System and the Medical College of Georgia are significant and may also be utilized by such Commission.
A joint hearing of the Senate and House Health and Human Services Committee should be held in January 2018 to discuss the findings of this Committee and to streamline discussion amongst the institutions in Georgia that monitor acute care problems including the Trauma Commission the Cardiovascular Commission and the Stroke Commission as well as possibly the Poison Control apparatus to expedite improved acute care in the state. In the future great efficiencies of scale may be possible with such a consortium.
The Georgia Stroke Commission should center around the following objectives and goals which should be discussed in more detail at the joint hearing o Prevention. Recognized preventable comorbidities (morbid obesity hypertension diabetes cardiovascular disease and peripheral artery disease) exist particularly in the underserved areas of the state which predispose an at-risk population to cerebrovascular insult. With appropriate treatment ofthese comorbidities stroke risk in Georgia could be substantially reduced. o Identify the at-risk population. Make aware on an individual and family basis the clinical picture of a cerebrovascular insult and ensure the stroke victim and his family are informed as to the quickest way to obtain emergency care (An emergency care plan for instance could be placed on the refrigerator of a patient at risk). o Endeavor to include all appropriate Georgia healthcare institutions in the state stroke system. o Expand and make use of telemedicine particularly in those areas where healthcare is limited. o Establish a state-wide 911 emergency hotline for stroke. (and possibly all acute healthcare issues.) Such a center would have knowledge of all stroke therapeutic resources on a 24-hour basis and could direct a stroke victim to the appropriate location for treatment and forewarn the receiving institution of the stroke victim s impending arrival. Make use of the Smart-Form platform for field triage of patients with stroke. Design validate and use a pre-hospital stroke scale for large vessel occlusion. In metropolitan Atlanta expand the use of stroke-mobiles. When possible direct patients to a comprehensive stroke center as the first therapeutic choice. o The Impact of the DAWN Trial. If possible all patients should be taken to the closest available institution for aCT and TPA within 6 hours ofthe acute event. lfthis is not possible those patients with a stroke onset between 6 to 24 hours should go to a comprehensive stroke center-
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moreover logically statistics should be collected on all acute stroke patients up to a 24-hour period. o Understand and expand the efficiencies and benefits of after-stroke care. o Understand the economic issues of stroke care its cost and efficiency of investment in prevention as well as after-care. The stroke commission should also explore the economic utility of the use of helicopter and ambulance transport. Finally the Committee supports and appreciates the ongoing efforts of DPH in establishing statewide systems of care in Georgia including the updates to the Coverdeii-Murphy Act in 2015. Specifically the Committee applauds DPH s role in establishing the State Office of Cardiac Care and implementing SB 102 from 2017 allowing Georgia to become the third state in the nation to create such a system (following Washington State and Arizona).
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Respectfully Submitted
FINAL REPORT OF THE STROKE TRAUMA SENATE STUDY COMMITTEE
Senator District 18
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