1. Edward P. Sloan, MD, MPH, FACEP Emergency Department Neurological Patient Emergencies: Optimizing Patient Outcomes, Minimizing Medical Legal Risk

2. Edward P. Sloan, MD, MPH, FACEP A Focus on Acute Ischemic Stroke Patient Care in the ED

3. Edward P. Sloan, MD, MPH, FACEP Atlantic City, NJ September 15, 2008 2008 EMA Advanced Emergency & Acute Care Medicine Conference Atlantic City, NJ September 15, 2008

4. Edward P. Sloan, MD, MPH, FACEP Edward P. Sloan, MD, MPH FACEP Professor Department of Emergency Medicine University of Illinois College of Medicine Chicago, IL

5. Edward P. Sloan, MD, MPH, FACEP Attending Physician Emergency Medicine University of Illinois Hospital Chicago, IL

6. Edward P. Sloan, MD, MPH, FACEP

9. Disclosures FERNE Chairman and President FERNE Chairman and President Speakers bureau for The Medicine Company Speakers bureau for The Medicine Company No grant support for this program No grant support for this program

10. Edward P. Sloan, MD, MPH, FACEP www.ferne.org

16. Ischemic Stroke Patient Case Presentation

17. Edward P. Sloan, MD, MPH, FACEP

21. Clinical History A 62 year old female acutely developed aphasia and right sided weakness while in a store. The store clerk immediately called 911. Paramedics on the scene within 9 minutes, at 6:43 pm. She arrived in the ED at 7:05 pm… completed her head CT at 7:25 pm… and a neurology consult was obtained at 7:35 pm (approximately one hour after the onset of her symptoms). A 62 year old female acutely developed aphasia and right sided weakness while in a store. The store clerk immediately called 911. Paramedics on the scene within 9 minutes, at 6:43 pm. She arrived in the ED at 7:05 pm… completed her head CT at 7:25 pm… and a neurology consult was obtained at 7:35 pm (approximately one hour after the onset of her symptoms).

22. Edward P. Sloan, MD, MPH, FACEP ED Clinical Exam VS: 98 F, 90, 16, 116/63, 98% RA, 50 kg VS: 98 F, 90, 16, 116/63, 98% RA, 50 kg The pt was alert, was able to slowly respond to simple commands. The pt had a patent airway, no carotid bruits, clear lungs, and a regular cardiac exam. PERRL. There was neglect of the R visual field. There was facial weakness of the R mouth, and R upper and lower extremity flaccid paralysis. DTRs were 2/2 on the L and 0/2 on the R. The pt was alert, was able to slowly respond to simple commands. The pt had a patent airway, no carotid bruits, clear lungs, and a regular cardiac exam. PERRL. There was neglect of the R visual field. There was facial weakness of the R mouth, and R upper and lower extremity flaccid paralysis. DTRs were 2/2 on the L and 0/2 on the R.

23. Edward P. Sloan, MD, MPH, FACEP Medical Legal Landscape Regarding EM Stroke Patient Care

24. Edward P. Sloan, MD, MPH, FACEP Medical Legal Overview  There exist today, over 10 years since the NINDS publication, concern and controversy regarding the use of IV tPA in ED acute ischemic stroke patients  This is due, in part, to the statements made by practitioners, lawyers, and EM organizations

25. Edward P. Sloan, MD, MPH, FACEP

36. FERNE Feedback  “You do not provide a balanced lecture that includes contrary viewpoints regarding tPA use…”  In reply: “The standard of care is established by the experts who are willing and able to testify that tPA is an approved therapy for the treatment of acute ischemic stroke patients in the ED…”

37. Edward P. Sloan, MD, MPH, FACEP Medical Legal Risk Mitigation: An Assessment

38. Edward P. Sloan, MD, MPH, FACEP Risk Mitigation in EM  High quality care always stands out as such (as does low quality care)  If you act in a way that is systematic, straightforward, and always advances the best interests of the patient, risk is minimized for both the patient and practitioner

39. Edward P. Sloan, MD, MPH, FACEP Risk Mitigation in EM  If the patient always is provided the best chance for a good outcome based on your actions, risk is minimized regardless of the actual outcome  This approach is possible with tPA use in ED acute ischemic stroke patient care by EM physicians

40. Edward P. Sloan, MD, MPH, FACEP Public Perceptions  Every person has an opinion about the potential use of tPA in acute ischemic stroke  These people are most often not physicians or rocket scientists  These opinions matter, establishing the standard of care  Was proper procedure followed?

41. Edward P. Sloan, MD, MPH, FACEP Challenger Disaster

42. Edward P. Sloan, MD, MPH, FACEP Challenger Disaster  A teacher watching the takeoff commented:  ‘I never once had seen icicles on the space shuttle prior to take-off. It had never been freezing the night before a launch prior to the Challenger disaster’  Not a rocket scientist, but an opinion none the less…perhaps valid, also!

43. Edward P. Sloan, MD, MPH, FACEP

44. Arizona Controlled Burn

45. Edward P. Sloan, MD, MPH, FACEP Arizona Controlled Burn

46. Edward P. Sloan, MD, MPH, FACEP Arizona Controlled Burn  When asked about the fact that the controlled burn went out of control and homes were burned, the government official stated:  ‘These things happen…I am most interested in knowing whether or not proper procedure was followed in order to minimize the chances of this happening.’

47. Edward P. Sloan, MD, MPH, FACEP Translation  Stuff happens.  Were things done the right way, or did something happen because somebody didn’t do his or her job?  In other words, was it fated to happen or was a mistake made?  This is always the critical question when a bad outcome occurs.

48. Edward P. Sloan, MD, MPH, FACEP Conclusions  What is “appropriate” is determined by all of us who are part of this process: patients, families, officials, and physicians  Most of the legal issues are straightforward systems issues that are seen and understood by those who do not practice EM

49. Edward P. Sloan, MD, MPH, FACEP Recommendations  We, as the Emergency Medicine specialists, must take charge, lead the process, and promote excellence in ischemic stroke patient care  We must act in a way that enhances clinical practice, patient care, and patient outcomes for ED ischemic stroke patients

50. Edward P. Sloan, MD, MPH, FACEP The Medical Record

51. Edward P. Sloan, MD, MPH, FACEP MR is Like a Kevlar Vest  It is your greatest source of protection  It protects you such that it must always be used wisely, as is the case with police officers  You often don’t know when it protects you

52. Edward P. Sloan, MD, MPH, FACEP MR is Like a Seeing Device  You see things that can only be seen as you write up the chart  You only know fully what you know and what you must do once the record is completed  It promotes excellence in patient care

53. Edward P. Sloan, MD, MPH, FACEP Specific Recommendations: Documenting in the Medical Record

54. Edward P. Sloan, MD, MPH, FACEP Emergency Medicine Recommendations

55. Edward P. Sloan, MD, MPH, FACEP Stroke Pt Diagnosis  ‘The pt has symptoms that are fixed and are consistent with an acute ischemic stroke’

56. Edward P. Sloan, MD, MPH, FACEP Stroke Neurological Exam  Document a systematic neurological exam, one that can be used to estimate the NIHSS  Make the exam function based  What is the patient able to do?

57. Edward P. Sloan, MD, MPH, FACEP Stroke Neurological Exam  LOC: Somnolent, responds to tactile stimuli  Vision: Noted L visual field deficit  Speech: Slurred speech  Receptive: Understand commands  CN Motor: L sided mouth droop  Extremity Motor: L sided paralysis  Pronator drift of L arm

58. Edward P. Sloan, MD, MPH, FACEP Stroke Neurological Exam  Sensory: Decreased light touch L  Gag reflex: Able to control airway  Pathological reflexes: Toes down going, negative Babinski  Neglect: L sided neglect

59. Edward P. Sloan, MD, MPH, FACEP Estimate the NIHSS  ‘The approximate NIHSS was 12-18, in the range that suggests that IV tPA may be of benefit as was the case in the NINDS clinical trial’

60. Edward P. Sloan, MD, MPH, FACEP Stroke Onset Time  ‘The ischemic stroke onset time has been confirmed in the following way, suggesting the three hour window for IV tPA has not expired’

61. Edward P. Sloan, MD, MPH, FACEP Stroke CT Interpretation  ‘The CT has been reviewed and has been cleared by the radiologist who is aware of the potential use of IV tPA’

62. Edward P. Sloan, MD, MPH, FACEP Blood Pressure Rx  ‘The blood pressure was stabilized without extraordinary intervention and was consistently less than 185/110, allowing for safe IV tPA use’

63. Edward P. Sloan, MD, MPH, FACEP IV tPA Informed Consent  ‘The following were discussed with the patient and family: With tPA, there is a 30% greater chance of a good outcome at 3 months With tPA, there is a 30% greater chance of a good outcome at 3 months With tPA use, there is 10x greater risk of a symptomatic ICH (severe bleeding stroke) With tPA use, there is 10x greater risk of a symptomatic ICH (severe bleeding stroke) Mortality rates at 3 months are the same regardless of tPA use, because stroke is a bad disease Mortality rates at 3 months are the same regardless of tPA use, because stroke is a bad disease About two patients will improve for every one that develops a symptomatic ICH’ About two patients will improve for every one that develops a symptomatic ICH’

64. Edward P. Sloan, MD, MPH, FACEP IV tPA Informed Consent  If you document in the medical record, state the specifics  ‘The following individuals were part of and consented to the decision to use IV tPA’  If not, use a specific consent form with the data printed on it

65. Edward P. Sloan, MD, MPH, FACEP IV tPA Risk/Benefit  ‘The potential risks and benefits of the use of IV tPA were discussed with the patient and/or family and these discussions lead to the decision to treat (not to treat) with IV tPA’

66. Edward P. Sloan, MD, MPH, FACEP IV tPA Contraindications  ‘The stroke pt was not a candidate for IV tPA because the time of stroke onset was not conclusively determined’  ‘IV tPA was not indicated because of the presence of AFIB and an approximate NIHSS above 20’  There were no specific …

67. Edward P. Sloan, MD, MPH, FACEP NINDS Protocol Followed  ‘I am aware of the specifics of the NINDS protocol regarding IV tPA use and followed the protocol in order to maximize the likelihood of a good outcome for this patient’

68. Edward P. Sloan, MD, MPH, FACEP tPA Not Clinically Indicated  ‘IV tPA was NCI in this ischemic stroke patient for the following reasons:  Risk/Benefit profile does not suggest improved outcome with IV tPA use  Stroke onset time unclear  Pt/Family decline use  Systems in place do not favor its use’

69. Edward P. Sloan, MD, MPH, FACEP ED Systems Recommendations

70. Edward P. Sloan, MD, MPH, FACEP Obtain the CT Quickly  ‘The ED staff and CT techs were informed that the CT for this patient had to be expedited because of the potential use of IV tPA’

71. Edward P. Sloan, MD, MPH, FACEP Obtain a CT Read Quickly  ‘The CT techs and radiologists were informed that the CT reading for this patient had to be expedited because of the potential use of IV tPA’

72. Edward P. Sloan, MD, MPH, FACEP Obtain a Directed CT Read  ‘The CT techs and radiologists were informed that the CT reading for this patient was for the specific purpose of determining if the potential use of IV tPA was appropriate’

73. Edward P. Sloan, MD, MPH, FACEP Obtain Consults Early  ‘The neurologist was notified of the potential use of IV tPA prior to obtaining the head CT so that he could be present in the ED at the time of the decision to administer tPA, if indicated’

74. Edward P. Sloan, MD, MPH, FACEP Document Neurologist Agreement with Plan  ‘The neurologist was fully aware of the circumstances surrounding the use of IV tPA and fully concurred with the decision by the patient, family, and myself’  ‘A neurologist remote was consulted via phone (or telemedicine)’  ‘No neurologist was available prior to the administration of tPA’

75. Edward P. Sloan, MD, MPH, FACEP Pt, Family Interactions ‘Risks and benefits were fully explored with the patient and relatives, leading to the decision to use tPA’‘Risks and benefits were fully explored with the patient and relatives, leading to the decision to use tPA’

76. Edward P. Sloan, MD, MPH, FACEP IV tPA Dosing, Time ‘Based on the clearly established time of stroke onset and the estimated (how) pt weight, at 8:21 pm, approx 1’45” after CVA sx onset: Initial bolus: 5 mg slow IVP over 2 min Infusion: 40 mg infusion over 1 hour’

77. Edward P. Sloan, MD, MPH, FACEP Avoid Blood Thinners Order the following: ‘Besides ASA, no additional blood thinners such as coumadin, heparin, or plavix should be administered to this patient because of the use of IV tPA’

78. Edward P. Sloan, MD, MPH, FACEP ED Ischemic Stroke Patient Outcome

79. Edward P. Sloan, MD, MPH, FACEP Clinical Case: CT Result

80. Edward P. Sloan, MD, MPH, FACEP Clinical Case: ED Rx CT: no low density areas or bleed CT: no low density areas or bleed No contraindications to tPA, BP OK No contraindications to tPA, BP OK NIH stroke scale: approx 18-20 NIH stroke scale: approx 18-20 Neurologist said OK to treat Neurologist said OK to treat tPA administered, no complications tPA administered, no complications

81. Edward P. Sloan, MD, MPH, FACEP tPA Administration tPA dosing: tPA dosing: 8:21 pm, 1’45” after CVA sx onset8:21 pm, 1’45” after CVA sx onset Initial bolus: 5 mg IVP over 2 minutesInitial bolus: 5 mg IVP over 2 minutes Follow-up infusion: 40 mg, 1 hourFollow-up infusion: 40 mg, 1 hour

82. Edward P. Sloan, MD, MPH, FACEP Repeat Patient Exam Repeat neuro exam at 90 minutes:Repeat neuro exam at 90 minutes: Repeat Exam: Increased speech & use of R arm, decreased mouth droop & visual neglectRepeat Exam: Increased speech & use of R arm, decreased mouth droop & visual neglect Repeat NIH stroke scale: approximately 12-14Repeat NIH stroke scale: approximately 12-14

83. Edward P. Sloan, MD, MPH, FACEP Hospital Course & Disposition Hospital Course: No hemorrhage, improved neurologic function Hospital Course: No hemorrhage, improved neurologic function Disposition: Rehabilitation hospital Disposition: Rehabilitation hospital 3 Month Exam: Near complete use of RUE, speech & vision improved, slight residual gait deficit 3 Month Exam: Near complete use of RUE, speech & vision improved, slight residual gait deficit Able to live at home with assistance Able to live at home with assistance

84. Edward P. Sloan, MD, MPH, FACEPConclusions The IV tPA skill set is identified, limited, and manageable It is possible to provide quality emergency care with IV tPA and meet a reasonable care standard Identify good patient candidates Make it happen quickly Document the ED management

85. Edward P. Sloan, MD, MPH, FACEPConclusions Guidelines, clinical studies, and review articles do provide guidance Treatment options must be individualized for each patient Specific strategies are defined It is possible to practice within a reasonable standard of care Pt outcomes can be optimized

86. Edward P. Sloan, MD, MPH, FACEPConclusions A high standard is achievable The record makes this happen Good documentation minimizes risk Good documentation enhances likelihood of a good outcome Documenting the ED management is a critical step in the Rx plan

87. Edward P. Sloan, MD, MPH, FACEPRecommendations Do it right! Be an expert and demonstrate it by documenting well in the record Use IV tPA to treat ischemic stroke patients when indicated Know the numbers and nuances Improve patient care and EM practice Do so without excessive risk

88. Edward P. Sloan, MD, MPH, FACEP Questions? edsloan@uic.edu 312 413 7490 www.ferne.org ferne_ema_2008_neuro_emergencies_sloan_medical_legal_091408_finalcd 5/9/2015 8:17 AM