Primary Stroke Service (PSS): A Primer

1. Primary Stroke Service (PSS): A Primer Mirian Barrientos, MPH, CPHQ Joanne LaBelle, RN, MS, CPHQ, HRM Online Module

2. Bureau of Infectious Disease Prevention, Response and ServicesMassachusetts Department of Public Health • In accordance with the ACCME Standards for Commercial Support of CME, the speakers for this course have been asked to disclose any relevant relationships with commercial entities that are either providing financial support for this program or whose products or services are mentioned during their presentations. • Both presentation authors have nothing to disclose. 2

3. Learning Objectives Define the purpose of PSS regulations. State the importance of documenting the time of last known well (LKW) or symptom onset. Describe the PSS survey process. Identify requirements of the PSS regulations. Recognize the signs and symptoms of stroke. List life-style changes for preventing stroke. 3

4. Introduction: Why do we have PSS?

5. What is PSS designation? • PSS is Primary Stroke Service. • MA State PSS regulations passed in 2004: • PSS designated hospital MUST have the capacity to accurately diagnose and treat stroke, 24 hours/day, 7 days/week. • EMS services are directed to take possible stroke patients to PSS hospitals. • Emergency diagnostic & therapeutic services are provided by a multi-disciplinary team.

6. Importance for Clinical Staff • Required services must be available 24/7… makes the provider’s job easier! • Validates that the hospital is meeting minimum standards for stroke care, allowing EMS to bring possible stroke patients in for care. • PSS participation provides comparison data to assist in the QI process.

7. History of PSS Designation • March 2004: PSS regulations developed • September 2004: PSS designation begins • July 2005: PSS data collection begins • July 2005: Adoption of EMS Point of Entry (POE) plan • As of February 2012, 70 of the 72 eligible MA acute care hospitals are PSS designated

8. PSS Hospitals in MA

9. Regulatory requirements

10. PSS Ongoing Monitoring Monitoring is done through periodic survey visits. Unannounced surveys are conducted for: • A stroke-related reported event. • A patient complaint related to stroke care.

11. PSS Survey Process Tours of ED and CT area Review of: Selected medical records Protocols Stroke Committee meeting minutes Community & provider education records Interviews with: Stroke coordinator & physician champion Members of the stroke committee Care providers

12. Provider’s Participation in a PSS Survey • The surveyor may tell registration staff that he/she is having a stroke and is brought through the ED care system. • The surveyor asks each provider encountered, “What is your role?” • Be sure to accurately describe the good work you do!

13. Update to Regulations (2004) DHCQ 04-4-440 (2004): • Document LKW in 100% of patients with suspected ischemic stroke, regardless of ED arrival time. • 100% of patients with suspected ischemic stroke presenting within 3 hours of symptom onset are evaluated for IV-tPA eligibility. • All ischemic stroke patients receiving IV-tPA are treated as rapidly as is safe and feasible, with the goal of IV-tPA within 60 minutes of ED arrival. • Under EMS POE plans, patients experiencing acute stroke symptoms are brought to PSS hospitals.

14. Update to Regulations (2005) • EMS Stroke POE plans implemented statewide. • Hospitals temporarily without CT capacity are not treated as a PSS hospital while CT is down. Unless the patient requires immediate stabilization, the hospital needs to notify EMS of the diversion status. • PSS hospitals are required to collect data on all eligible patients starting on or before July 1st.

15. Update to Regulations (2006) • PSS strongly encourages clinical review of all phases of stroke data collection and reporting. • Data element added: Hemorrhagic complications occurring within 36 hours of the administration of IV-tPA. • If transferring a patient post-IV-tPA, the sending hospital must contact the receiving hospital for complications occurring after transfer, and enter into registry. • Written transfer follow-up protocols are required.

16. PSS: Expanding the IV-tPA Window 2009 Update: • PSS does not have the authority to recommend or to prohibit use of IV-tPA in the expanded time window (3-4.5 hours). • Revision: Time target data does not need to be collected on an ongoing basis for all targets. However, it is expected that time target data is reviewed as part of the improvement process to assess delays in IV-tPA treatment.

17. Update to Regulations 2010 – 2011: Public release of hospital-specific performance data on the rate of eligible patients receiving IV-tPA for ischemic stroke in a PSS-designated ED. Instructions on how to create PSS hospital reports included allowing hospitals to review the information to be publically reported, prior to the release. 17

18. Time Targets

19. PSS Time Targets

20. PSS Time Targets (continued) 20

21. PSS Time Targets (continued)

22. Public PSS Data

23. Public Release of PSS Data Aggregate data released in 2009: Timeliness of Arrival to the ED Treatment with IV-tPA Brain Imaging Timeline: July 2009 release: 2006-07 aggregate data. September 2009 release: 2007-08 aggregate data. Hospital-specific data released in 2010 & 2011: Treatment with IV-tPA Comparison by region, bed size & teaching status Timeline: June 2010 release: 2007-08 data. October 2011 release:2008-09 & 2009-10 data. 23

24. Improvement in rates of IV-tPA use at PSS hospitals (2006-2010)

26. PSS and Protocols

27. What are the PSS requirements related to protocols? • The hospital must develop and implement written protocols for acute ischemic and hemorrhagic strokes based on previously published guidelines and/or developed by a multidisciplinary team. • Protocols must be available in the ED and other areas likely to assess/treat acute stroke patients. • All protocols/standard order sets must be reviewed and, if needed, revised at least annually.

28. What protocols are required by PSS? Examples include: • EMS communications plan • Identification of acute stroke team and triage plan • Patient clinical assessments, vital functions, monitoring • Systems to promptly perform diagnostic tests • Use of medications • Time target goals • Telemedicine services • Post-admission care • Patient/family education • IV-tPA follow-up process

29. What is expected re: follow-up for IV-tPA complications? Written protocols are jointly developed by hospitals routinely transferring and receiving patients. At a minimum, the protocol includes: The title of the contact at the transferring hospital, The title and contact information for the representative at the receiving hospital providing information on the complications. Information on the timeline and follow-up process. 29

30. Is a generic transfer agreement acceptable? A transfer agreement must: Describe the responsibilities of each hospital. Be signed by the Stroke Service Director, the Medical Director of each hospital or designee, and the CEO of each hospital or designee. If there is no reference to the transfer of stroke patients in the generic transfer agreement, an addendum must be written. A representative from both the sending and receiving hospitals must sign the addendum. 30

31. Stroke Committee

32. How do the Stroke Committee and Acute Stroke Team differ? • Stroke Committee: • A Committee designated by the governing body that includes the physician serving as Stroke Service Director or Coordinator. The Committee provides oversight for the Stroke Program and care outcomes. • Acute Stroke Team • Physician(s) and other health care professionals, e.g., nurse, physician's assistant, or nurse practitioner, with stroke expertise who are available to respond and evaluate patients presenting with acute stroke symptoms.

33. What is the responsibility of the Stroke Committee? • Annual review, and revision if needed, of all stroke protocols and order sets. • Review of reports including: • Number and types of stroke patients, • Nature of any complications of IV-tPA, • Compliance with PSS regulations, • Adherence to time targets • Based on data reports, direct the QI efforts to improve patient care.

34. Education Expectations

35. What are the ongoing qualifications for the Stroke Service Director? A licensed physician with acute stroke expertise defined any of the following: • Completion of a stroke fellowship. • Participation (as an attendee or faculty) in at least 2 regional, national, or international stroke courses or conferences annually. • 5 or more peer-reviewed publications on stroke. • 8 or more CMEs annually in the area of cerebro-vascular disease. • Or,other criteria approved by the governing body of the hospital.

36. What are the continuing education requirements for providers? • Hospitals must provide education for ED physicians, nurses, allied health professionals, and EMS personnel in acute stroke prevention, diagnosis and treatment. • The education is a minimum of 1 hour/year of formal stroke education. • Hospitals are encouraged to partner with other hospitals.

37. What does PSS consider “formal education”? • Acceptable methods: • Speaker forums (e.g., lectures, Stroke Grand Rounds) • Videos and audio conferences • Outside conferences • Webinars, e-learning modules • Stroke Morbidity and Mortality Meetings • Certification/recertification for ACLS and NIHSS • Demonstration of compliance: • Attendance sheets, topic and content outline • If not a live presentation: • A post-test is given, results are maintained • A system is in place to respond to participant’s questions

38. Why does PSS require community outreach? • To increase the number of patients eligible for IV-tPA, more timely ED arrival is important. • To share important information with the community, including: • Risk factors • Stroke signs and symptoms

39. What are the guidelines for community education? • Community education to the public must be targeted to the needs of each hospital’s community. • A significant percentage of the catchment areas population need to receive stroke education outreach. • The required content must be covered: • Stroke prevention • Recognition of stroke symptoms, and/or • Treatment of stroke

40. How do you document community education? • Acceptable methods: • Newsletters/Mailings and Newspapers • Public Service Announcements • Stroke education materials provided at community events • Education provided to area health care providers • Speaker Forums • Demonstration of compliance: • Log of the number of brochures used • Attendance sheets for live presentations • Copies of publicity for public events • Summary documentation of public events

41. Signs and Symptoms of Stroke

42. Vague Symptoms • Patients presenting with vague neurological symptoms may not be considered as having a possible stroke. • REMINDER: Vague neurological symptoms may be due to stroke. • Patients presenting with vague neurological symptoms should have an assessment and documentation re: potential for a stroke.

43. Examples: Vague Symptoms A list provides a trigger to facilitate an appropriate assessment and diagnostic treatment: • Acute mental status change, • Acute gait disturbance, • Acute speech disturbance, • Vertigo, Syncope, Dizziness • Giddiness, • Diplopia, • Expressive aphasia, • Headache, • Limb weakness and/or fall with unknown reason, • Numbness/tingling, • Possible seizure, • Weakness.

44. Could this be a stroke? If YES: Using the eligibility criteria, if the patient screens-in as IV-tPA appropriate, begin... • If the patient may be appropriate for IV-tPA, begin and DOCUMENT informed consent. Inform the patient he/she may be a candidate for IV-tPA and provide the patient/family with information. • Follow the protocol for an acute stroke evaluation, including activating the stroke team and the implement the stroke standard order set.

45. Could this be a stroke? If NO, Using eligibility criteria, screen for the appropriateness of IV-tPA. If the patient would not be eligible due to a contraindication or minimal deficit, document in the chart! For example: • DOCUMENT the reason why you believe the diagnosis is not a stroke. • If uncertain, document if the patient is diagnosed with a stroke, the reason he/she would not be eligible for IV-tPA. For example, “Stroke considered, however, if this is a stroke, IV-tPA is not appropriate because the symptoms are too mild.”

46. Dysphagia Screening • Screen for dysphagia on ALL potential stroke patients, as they may have impaired swallowing. • If the patient passes the screen, oral medications and oral nutrition MAY be given if deemed appropriate. If the patient fails the screen, maintain the NPO status and request a Speech and Language Therapist’s assessment. • Use the vague symptom list to identify patients that MAY be discharged as a stroke patient.

47. LKW and Symptom Onset • LKW: “Last known well" (LKW) is used to identify when the patient was either last seen or last known to be at baseline (usual state of health). This may change with various observers. If the last known well time cannot be identified, document it is not known. • Time of symptom onset: The time when a patient experiences the start of symptoms, in the company of an individual able to verify that the patient was functioning normally up until the start of symptoms. • LKW and symptom onset MAY be the same if someone witnesses the exact time symptoms begin.

48. Stroke Diagnosis: FAST • F (Face): Ask the person to smile. Does one side of the face droop? • A (Arms): Ask the person to raise both arms. Does one arm drift downward? • S (Speech): Ask the person to repeat a simple phrase. Is their speech slurred or strange? • T (Time): Time is brain. If you observe any of these signs, call 911 immediately. FAST materials available at: http://massclearinghouse.ehs.state.ma.us/heart-disease-and-stroke-prevention

49. Stroke Prevention: Modifiable Risk Factors • High blood pressure • Atrial fibrillation • High cholesterol • Diabetes • Atherosclerosis • Circulatory Problems • Tobacco use and smoking • Alcohol use • Physical inactivity • Obesity

50. Stroke Prevention: Non-Modifiable Risk Factors • Age (over age 55) • Gender (male) • Race, high risk: • African American, • Hispanic or • Asian/Pacific Islander • Family history • Previous stroke or TIA • Fibromuscular dysplasia • Patent foramen ovale