Systematic Hospital - based Secondary Prevention

1. Systematic Hospital - based Secondary Prevention The Stroke PROTECT Program PreventingRecurrenceOf Thrombo- embolicEventsthroughCo-ordinated Treatment

2. Secondary Stroke Prevention Lecture Series • Overview of the PROTECT Program and Antiplatelets in Stroke Prevention • Statins and Lifestyle Modification Approaches • Stenting and Carotid Endarterectomy • Risk Factor Reduction in Hypertension and Atrial Fibrillation

3. Stroke: A Major Public Health Burden • One stroke occurs in the US every 53 seconds • Third leading cause of death • >150,000 deaths per year in US • >750,000 new strokes per year in US • >4,400,000 stroke survivors in US • Leading cause of adult disability • Most preventable of catastrophic conditions

4. Age and Gender-Specific Stroke Incidence:Northern Manhattan Stroke Study 931 857 688 650 629 468 392 184 175 76 13 42 46 8 7 4 Age Groups (y) Sacco R et al. Am J Epidemiol. 1998;147:259-268.

5. Cumulative Risk of Stroke Post-TIA (%) Post-Stroke (%) 3 – 10 5 – 14 25 – 40 30 days 1 year 5 years 4 – 8 12 – 13 24 – 29 Sacco. Neurology. 1997;49(suppl 4):S39. Feinberg et al. Stroke. 1994;25:1320.

6. Prognosis After Transient Ischemic Attack (TIA) 1707 patients with TIA identified by emergency department physicians 1.0 Stroke 10.5% 0.9 Probability of Survival Free From Stroke and Adverse Events 0.8 Adverse events 25.1% (stroke, cardiovascular hospitalization, death, or recurrent TIA) 0.7 0.6 0 7 30 90 60 Days After TIA Number of Patients at Risk Stroke 1001 1577 1527 1480 1451 Adverse events 1001 1462 1361 1293 1248 Johnston SC, et al. JAMA. 2000;284:2901-06.

7. Management of Stroke The best approach towards reducing the immense burden that stroke places on our society remains prevention

8. Modifiable Stroke Risk Factors Medical Conditions • Hypertension • Cardiac disease • Atrial fibrillation • Hyperlipidemia • Diabetes mellitus • Carotid stenosis • Elevated homocysteine • Prior TIA or stroke Behaviors • Cigarette smoking • Heavy alcohol use • Physical inactivity

9. RF Control: Impact on Stroke Prevention • >750,000 strokes annually in the US • Preventable strokes • Hypertension 369,000 • Hypercholesterolemia 150,000 • Tobacco Use 91,500 • Atrial Fibrillation 47,000 • Heavy Alcohol Use 35,200 --Modified from Gorelick, Neuroepidemiology 1997

10. Emerging Strategies • Atherosclerosis is responsible for the majority of ischemic strokes • Destabilization of the atheromatous plaque is a forerunner of ischemic stroke • This plaque is now the main focus for new directions in prevention and treatment of cerebrovascular atherosclerosis

11. Overlap of Vascular Disease in Patients With Atherothrombosis Ischemic stroke Unstable angina MI PAD Platelet adhesion, activation, and aggregation Plaque rupture Thrombus formation Vascular events (MI, stroke, or CV death) Ness J, Aronow WS. J Am Geriatr Soc. 1999;47:1255-1256. Schafer AI. Am J Med. 1996;101:199-209.

12. Thrombus P l a t e l e t s Atherosclerotic Plaque Stable Unstable Lumen Endothelium Lipid Rich Core ThickFibrous Cap Thin Fibrous Cap Falk E et al. Circulation. 1995;92:657–671.

13. Stroke Subtypes

14. Stroke Subtypes Frequency of High Risk Atherosclerosis Patients in Stroke Large vessel 100% 35% Small Vessel 80% 16% Cardioembolic 60% 15% Total 66%

15. The Evidence - Practice Gap “ Despite compelling scientific evidence and national treatment guidelines supporting the use of secondary prevention medical therapies, these treatments continue to be underutilized in CVD patients receiving conventional care ”

16. The Evidence – Practice Gap in Implementing 2o Prevention in Stroke Patients • Coverdell Acute Stroke Registries Pilot Data • 4 states, 7474 consecutive admissions, 2001-02 Lipid profile done 42% Antithrombotic at discharge 89% Warfarin for atrial fibrillation* 67% Smoking cessation counseling 24% *(Among patients with no MD documented contraindication) --Frankel et al, Intl Stroke Conf, 2/03

17. The Evidence – Practice Gap in Implementing 2o Prevention in Stroke Patients • UHC Ischemic Stroke Benchmarking Project • 35 Academic Medical Centers, 1206 consecutive admissions, 2001 Antithrombotic at discharge 89% Warfarin for atrial fibrillation* 57% Smoking cessation counseling 40% Patient educated about stroke 32% *(Among patients with no MD documented contraindication)

18. Selected Barriers to Translating Clinical Trials into Clinical Practice • Physician • Lack of knowledge of current evidence • Time constraints • Desire to avoid iatrogenic complications • Patient • Polypharmacy • Time • Financial • Intrinsic difficulty of lifestyle change • Health system • Uninsured and underinsured individuals • Care of chronic illness not organized systematically • High cost of health care --Rich, JAMA 2002

19. Incentives for Change • NCQA/HEDIS/JCAHO/GOA reporting measures • Hospitals • Managed Care • Physicians • Consumer demand for quality care / report cards • AHA/ASA/JCAHO Stroke Center designation

20. Stroke Treatment System Goals • Implement initiatives to put evidence- based guidelines into action • Improve the quality of care for patients with established cerebrovascular disease • Reduce secondary events - and save lives --Adapted from Fonarow, CHAMP, 2003

21. How about a Hospital Based System? Problem: Large CVD treatment gap and poor patient compliance with conventional management Solution: In-hospital initiation of therapy with excellent treatment rates and long term patient compliance Simple, Rapid, and Most Importantly Effective

22. Why a Hospital Based System? • Patients • Patient Capture Point • Have patients/family attention: “teachable moment’ • Predictor of care in community • Hospital Structure • Standardized processes/protocols/orders/teams • JCAHO • Process Improvement Examples • HCFA--Peer Review Organizations --Adapted from Fonarow, CHAMP, 2003

23. Stroke/TIA Patient Flow in the Hospital Advocate/Champion Inpatient Care Group Practice Outpatient Care Medical Ward Quality Control Stroke Unit Neurologist 850,000 NICU/ICU 660,000 Acute Cerebrovascular Event Discharge Nurse Primary Care MD ED Neurology Medicine LOST Discharged ~25,000 Telemetry Inpatient Rehab Pharmacy Outpatient Rehab 15% Protocol development process Implementation

24. BARRIERS 1. Communication gaps - neurologists vs PCPs 2. Lack of ownership - acute vs chronic disease dilemma 3. Poor standardization of orders, testing 4. Lack of financial incentives 5. Lack of tools/resources 6. Lack of proof of concept SOLUTIONS 1. Education and mobilizing case management teams 2. Hospital is the capture point for patients with acute disease 3. Preprinted orders, testing per protocol 4. Joint Commission, NCQA, PROs will be measuring and reporting 5. GWTG – Stroke, PROTECT 6. UCLA PROTECT demonstrates improved treatment rates Challenges to In-Hospital Initiation of Secondary Prevention Strategies --Adapted from Fonarow, CHAMP, 2003

25. Challenges to a Hospital Based System this will not work in a community hospital the neurologists will not agree to this we can not get a consensus the primary care physicians will not agree to this the managed care organization will not pay for it patients do not want to be on a lot of medications there is not enough time the lipid panel in not accurate when drawn in the hospital it may not be safe to start blood pressure lowering medications in hospitalized patients it will cost too much this will benefit the competition what about the liability the hospital administration will not pay for it there are exceptions x, y, and z it will take too much time it is too hard to get things through the hospital committee the patients should all be followed in my lipid clinic the physicians at my hospital do not like cookbook medicine we do not have anyone to collect this data --Adapted from Fonarow, CHAMP, 2003

26. UCLA Stroke PROTECT Program • Novel and aggressive hospital-based quality improvement program designed to reduce the devastating consequences of recurrent stroke through improved use of evidence-based secondary prevention treatments

27. Hypothesis • In-hospital initiation of evidence-based secondary stroke prevention therapies would result in improved physician adherence, patient compliance, and treatment rates both at time of discharge and during longer term follow-up.

28. Design • Focused on achieving 4 behavioral goals + 4 pharmacologic goals in all cervicocephalic atherothrombotic disease patients prior to hospital discharge • Use of program tools including preprinted orders, simple guidelines, and prospective monitoring of treatment use • Started in 2002 and current template of care at UCLA

29. Eligibility • Inclusion Criteria: • Diagnosis of ischemic stroke or transient ischemic attack  • Extent of participation will depend on patients stroke sub-type and co-morbid vascular risk factors • Exclusion Criteria : • Intracranial Hemorrhage

30. Program Goals Appropriate Hospital Initiation and Maintenance of : Antithrombotic ACE Inhibitor/ ARB Statin Thiazide diuretic Exercise Education Diet Education Smoking Cessation Awareness of Stroke Warning signs

31. Antithrombotics • Treatment of choice for prevention of strokes due to large vessel atherosclerotic disease and intracranial branch atheromatous (lacunar) disease • Current guidelines recommend daily therapy with either aspirin, clopidogrel, or aspirin/dipyridamole as first-line agents Albers et al, Chest 2001

32. Statins FDA New Labeling (based on HPS study) • April 17, 2003 • Indicated for patients with “stroke or evidence of cerebrovascular disease” All patients with atherosclerosis, regardless of baseline LDL unless contraindicated, should be started on a statin

33. ACE Inhibitors/ Angiotensin Receptor Blockers All patients with atherosclerosis regardless of blood pressure, unless contraindicated should be started on an ACEI/ ARB. These agents reduce blood pressure & have potent vascular effects including: • Increased vascular compliance • Regression of periarteriolar collagen area and total interstitial collagen volume density • Reduction in the arteriolar wall area • Normalization of resistance artery structure

34. Thiazide Diuretics • “Thiazide-type diureticsshould be used in drug treatment for most patients with uncomplicatedhypertension, either alone or combined with drugs from otherclasses”. • “Recurrent strokerates are lowered by the combination of an ACE inhibitor andthiazide-type diuretic”. JNC 7 Report, JAMA 2003

35. Medical Regimen Follow-up • Continuation of the therapies targeting the underlying atherosclerosis disease process markedly improves clinical outcome in Stroke patients with atherosclerosis. • The continued beneficial therapies prescribed should be strongly reinforced during patient follow-up.

36. Medication Discontinuation Rates • Various randomized trials of antithrombotic agents in secondary stroke prevention have shown the efficacy of these agents and included data on side effects and dropout rates. • However, there is a paucity of published data on adverse events and discontinuation rates following initiation of these agents in a non-study setting.

37. VA Greater Los Angeles Healthcare System [VAGLAHS] Study The Incidence of Discontinuation of Clinical trial proven Antithrombotic therapies in the Secondary Prevention of Stroke Dergalust et al 2003

38. VAGLAHS Study - Objective • Retrospective quality assurance review to determine the frequency with which extended release dipyridamole/aspirin, clopidogrel and warfarin are discontinued after being initiated for secondary stroke prevention and to determine the reasons for their discontinuation. Dergalust et al 2003

39. VAGLAHS Study – Methods/ Design • Data was collected for 700 patients VA GLA Healthcare system for the period of January 2000 to December 2001. • 528 of the 700 patients met inclusion criteria. • All patients had to be diagnosed with a stroke or a TIA in the VAGLAHS and were on extended release dipyridamole/aspirin, clopidogrel or warfarin for secondary stroke prevention • Primary Endpoint: Permanent discontinuation of the antithombotic agent for any reason Dergalust et al 2003

40. VAGLAHS Study ResultsDuration of Therapy Dergalust et al 2003

41. VAGLAHS Study Results Incidence of Discontinuation • Antithrombotic therapy was discontinued in 27.57% of the patients • Reasons for discontinuation included: • Non compliance • MD error • MD preference • Bleeding complications • Other adverse effects • Patient preference Dergalust et al 2003

42. VAGLAHS Study Results Reason for Discontinuation Dergalust et al 2003

43. VAGLAHS Study - Conclusions • Physician error involved scenarios such as insufficient follow-up, inattention to the need for refills or prescription renewal, poor communication between the specialist and primary care provider, and system error. • Our study showsthat inappropriate discontinuation of antithrombotic therapy is not uncommon in a stroke-prone population and the most common cause for it is non-compliance. Dergalust et al 2003

44. PROTECT Tools • Stroke center staff pocket card • Preprinted Order Sheets • Clinical Pathways/ Care Maps • Nursing staff interdisciplinary stroke patient education record • Patient information packet • Template letters to primary/ referring physicians • Lab requisition sheet • Patient self monitor post discharge log • Phone and clinic follow-up records • Data abstraction form • Stroke PROTECT website

45. PROTECT Website Contents • Program Overview – algorithms, outcome measures, analysis • Program Evidence • Program Results • Getting Started • Program Tools - downloadable • FAQ • Patient Prevention Information • Power Point slides - downloadable • References • Useful links

46. PROTECT Systematic Implementation of Secondary Stroke Prevention Algorithm

47. PROTECT Outpatient Algorithm

48. PROTECT - Outcome Measures • Compliance with program goals documented • at discharge, days 14, day 90 and at 1 year • Vascular event (including stroke, TIA, myocardial infarction, and peripheral arterial occlusion) • at day 90, and at 1 year • Medication treatment complications • at day 14, day 90 and at 1 year

49. Impact of PROTECT pilot phase on Treatment Rates at Discharge --Ovbiagele et al, Stroke 2003

50. Impact of PROTECT on Treatment Rates at Discharge