1. Reducing External Barriers to Acute Stroke Care The INSTINCT Trial NIH / NINDS R01 NS050372

2. Background Stroke patients, properly treated with tPA, have an 11% absolute greater chance of a normal outcome compared to untreated patients. Current Treatment Rates are 1-3% of all ischemic strokes Optimized systems demonstrate treatment rates of 8-15%

3. Objectives Review INSTINCT trial methods for identification of local barriers Understand taxonomy of barriers to increasing tPA use in stroke Enhance awareness of local external barriers to tPA use in stroke Develop methods to address selected barriers

4. The INSTINCT Trial To test whether hospitals receiving the educational intervention have a ≥ 4% increase in appropriate tPA use compared to matched controls To test whether the intervention enhances EP knowledge, beliefs and attitudes regarding tPA use in stroke

5. INSTINCT Hospitals

6. Trial Specifics Multi-center, randomized, controlled trial testing a multi-level, systems-based, educational intervention Intervention based on adult education and behavior change theory Tailored to local needs by identifying local barriers Based on clinical pilot data

7. ControlIntervention Baseline 3 months 6 months 9 months CROSSOVER

8. Outcome Measures ∆ % of tPA-treated stroke patients ∆ % of “appropriately” tPA-treated stroke patients ∆ % of tPA-treated stroke patients pre- and post-intervention Pre- and post-intervention change in physician knowledge, beliefs and attitudes General measures of effectiveness of tx

9. What Barriers Prevent Physicians from Following Guidelines? Screened 5,658 articles describing barriers to guideline adherence 76 selected based on focus on clinical guidelines and examination of at least 1 barrier –Contained 120 different surveys –Evaluating 293 potential barriers Interrater reliability for selection, k = 0.93 Cabana et al: Why Don’t Physicians Follow Clinical Practice Guidelines? JAMA. 1999;282:1458-1465

10. Cabana, M. D. et al. JAMA 1999;282:1458-1465. Barriers to Physician Adherence to Practice Guidelines in Relation to Behavior Change

11. External Barriers: Overview Guideline related –Difficult to use –Inconvenient –Confusing / contradictory Patient related –Time to arrival –Patient expectations vs. reality Environmental –Lack of time –Lack of resources –Organizational constraints –Lack of reimbursement –Medical-legal issues Cabana et al: Why Don’t Physicians Follow Clinical Practice Guidelines? JAMA. 1999;282:1458-1465

12. Stroke Treatment Stakeholders Patients and Community EMS Emergency department staff RadiologyNeurology Intensive care staff Primary care physicians Administrators

13. Overcoming Barriers Data Questions Effectiveness Delivery Systems Specialist Support

14. External Barriers: Local Insert customized data from INSTINCT Barrier Assessment process for each intervention site

15. Local External Barriers: Emergency Physician Survey Insert customized data from INSTINCT Barrier Assessment process for each intervention site

16. Local External Barriers: Qualitative Assessment Insert customized data from INSTINCT Barrier Assessment process for each intervention site

17. Group Discussion: Solutions Tailor remaining discussion and slides to specific external barriers identified Examples follow

18. Transforming Acute Care Recognize stakeholders in treatment and find agreement Improve “Detection-Door- Data-Decision-Drug” process –Outpatient / ED –Inpatient Napoleon greeting Baron Larrey, his Surgeon-in-Chief at Waterloo

19. EP ABILITY TO Dx STROKE Variable reports Kothari 1996 - 100% sensitivity, 98.6% specificity Alder 1999 - 6/70 patients misdiagnosed (UK) Libman 1996 - 19% stroke “mimics”

20. Impact of Stroke System Development Study Locatio n N % Treated Year Grond et al Cologne10022% 1996 - 1997 Lindsberg PJ et al Helsinki752.14%1998-2001 Rymer et al Kansas City 14218.2%2000-2003 Heuschma nn et al German stroke registry 3843%2000

21. NEUROLOGY <50% neurologists treating with t-PA Significant number are skeptical Lack of reimbursement Lack of neurologists

22. RADIOLOGY Who can interpret CT’s? Availability of radiology interps What about early hypodensity? ECASS data Schriger study

23. ICH Management Suspecting ICH Stat Head CT Labs –CBC, Plts, Coags, Fibrinogen, T&S Prepare –6-8 units cryoprecipitate –6-8 units platelets Consultation –Neurosurgery –Hematology 149149 137 5858 52 48 14 17 168 84 141 113 163* 161* 120*

24. Tools ProtocolNIHSS Triage tools EMS tools Informed consent Post-treatment care guidelines

25. Brain Injury Group Access Contact information

26. Telemedicine: Results 24 patients evaluated over 2 years 50% with Telestroke consultation 75% of eligible patients treated with tPA Mean consult-to-drug time = 36 min Avoided transfer in 46% of patients

27. Decision: tPA Excluded Benefit still occurs – for patients and system Start stroke management pathway in ED Orders to begin now: –Aspirin –Thermoregulation –Glucose regulation –NPO - until swallowing evaluated –DVT Prophylaxis –Rehab/SW consults initiated

28. Larger Systems of Stroke Care Market forces / local interest GIS analysis Optimum locations for stroke centers Maximum coverage with minimum costs Combines models

29. The Current National Stroke Reality

30. A Vision of the Future…

31. The Impact (T.E. Dec 2003, 37 yo female RN)

32. Summary Thrombolytic treatment rates remain below those reported in optimized systems Multiple barriers exist to changing system behavior toward stroke A multi-level educational intervention creates the optimal chance for system change If successful, INSTINCT may serve as a model to enhance delivery of other complex medical therapies

33. Changing Stroke Systems