NSAIDs

1. NSAID Risk Communication:Findings from the Alabama NSAID Patient Safety StudyJeroan Allison, Erik Angner, Dan Cobaugh, Rachel Fry, Ellen Funkhouser ,Catarina Kiefe, Cynthia LaCivita, Michael Miller, Sharina Person, Maria Pisu, Midge Ray, Kenneth Saag, Michael Schmitt, Norman Weissman, PhDSept 14, 2009

2. NSAIDs • Provide important relief from chronic pain1 • 57% Americans currently using • 40% dual users • Important risk • Between ~3,000 and 16,000 attributable deaths/year2-3 • GI/CV risks well known • Renal risks less well known • Frequent unsafe prescribing 1The Harris Poll: National Consumer’s league; 2003 2Tarone. American Journal of Therapeutics . 2004; 11(1): 17-25. 3Singh. Journal of Rheumatology. 1999; 26(Supl 56): 18-24. 4Lanas. American Journal of Gastroenterology. 2005; 100(8): 1685-93. 2

3. Alabama NSAID Patient Safety Study:Goals • Examine patient risk awareness and patient-clinician communication overall and in the context of: • Race/ethnicity • Health literacy • Develop and test patient-physician intervention to promote: • Risk assessment, communication, & management • Safe prescribing

4. Alabama NSAIDs Patient Safety Study:Intervention Components • Standard • CME modules • NSAID monographs from ASHP • Enhanced • Point-of-care, paper-based patient tool • Patient activation1,2 • Shared decision making3 • Low literacy appropriate 1Roter. Patient Education & Counseling. 2001; 44(1):79-86. 2Cohen. Preventive Medicine. 1994; 23(3):284-91. 3Weed. Your Heal Care and How to Manage It. Essex Publishing, Vermont. 1975.

5. Alabama NSAIDs Patient Safety Study:Intensive Intervention 5

6. Alabama NSAIDs Patient Safety Study:Implementation Diagram Primary Care Physicians June 2005 – April 2006 Baseline Assessment R May 2006 Combined Intervention CME June 2006 – Feb 2007 Follow-up Assessment Follow-up Assessment

7. Alabama NSAIDs Patient Safety Study:Implementation Detail • Intense recruitment process • Alabama Practice-based CME Network • On-going relationship building • Patient eligibility • Age ≥ 50 years • Currently taking Rx NSAIDs ≥ 3 months • Eligibility screening in physicians’ office • Patient data collection • Computer assisted telephone interview after office visit • Unique pre-post intervention patients

8. Alabama NSAIDs Patient Safety Study:Baseline & Follow Up Patient Population

9. Alabama NSAIDs Patient Safety Study:Physician Characteristics

10. Alabama NSAID Patient Safety Study: Presentation Overview • Patient-clinician communication by race/ethnicity • Patient risk understanding and literacy • Randomized trial • Conclusions

11. Alabama NSAIDs Patient Safety Study:Racial/ethnic Disparities • Racial/ethnic disparities well-documented • Access, quality, outcomes • Important gaps remain, despite selective narrowing1 • Little known about NSAID disparities • Risk awareness • Use • Outcomes 12008 National Healthcare Disparities Report, AHRQ.

12. Alabama NSAIDs Patient Safety Study:NSAID Risk Awareness Follow up, n = 383

13. Alabama NSAIDs Patient Safety Study:Racial/ethnic Disparities Baseline, n = 404; p < 0.05 for all. Fry et al. Arthritis Rheum. 2007 Dec 15;57(8):1539-45.

14. Alabama NSAIDs Patient Safety Study:Patient-Pharmacist Communication Baseline and follow up, n = 687; *p < 0.001. LaCavita et al. J AM Pharm Assoc. 2009; 49: 110-5.

15. The Rheumatologist. 2(5) May 2008.

16. Alabama NSAID Patient Safety Study: Presentation Overview • Study Overview • Patient-clinician communication by race/ethnicity • Patient risk understanding and literacy • Randomized trial • Conclusions Miller et al. Journal of Health Communication. In press. Miller et al. Academy Health, 2009. Miller all. FDA Risk Communication Advisory Committee Meeting February, 2009.

17. Health Literacy • Capacity to • Obtain and understand health information • Make appropriate health decisions1 • Complex set of skills, not just ability to read • Difficult to measure 1US Dept of Health and Human Services. Healthy People 2010.

18. Health Literacy & Risk Management • Complexity in NSAID treatment decisions • Important pain relief & functional improvement • Serious risks • Risk profile varies with age, co-morbidity • Balancing complex treatment decisions requires patient engagement and health literacy

19. Alabama NSAIDs Patient Safety Study:Health Literacy Findings • Compromised literacy • 25% overall • African Americans and males at risk • Poor health literacy associated with: • Lower risk awareness • Worse health status • Written Medical Information at Pharmacies • Not read by patients with lower literacy levels • Not associated with NSAID risk awareness

20. Alabama NSAID Patient Safety Study: Presentation Overview • Study Overview • Patient-clinician communication by race/ethnicity • Patient risk understanding and literacy • Randomized trial • Conclusions

21. Alabama NSAIDs Patient Safety Study:Over-time Changes *p < 0.001

22. Alabama NSAID Patient Safety Study: Presentation Overview • Study Overview • Patient risk understanding by literacy • Patient-clinician communication by race/ethnicity • Randomized trial • Conclusions

23. Alabama NSAIDs Patient Safety Study:Risk Awareness, Communication, Behavior • Important gaps • Patient don’t understand risk • Physicians/pharmacists don’t communicate risk • Written information at pharmacies not effective • Those at greatest risk • African American • Low socioeconomic position • Low literacy • Intervention results • Over-time improvement in risk communication • No difference between standard and enhanced interventions

24. Supplementary Slides

25. Alabama NSAIDs Patient Safety Study:Health Literacy and Health Status Health status from, “How would you rate your overall health?” Low health literacy defined as levels 1 or 2 from single Chew question.

26. Alabama NSAIDs Patient Safety Study:NSAID Risk Awareness by Health Literacy for Patients Age ≥ 65 Years p< 0.001

27. Alabama NSAIDs Patient Safety Study: Estimated Health Literacy Follow up, n = 383 “How confident are you in filling out medical forms by yourself?” Chew et al. Fam Med. 2004; 36(8): 588-594. Wallace et al. J Gen Intern Med. 2006; 21: 874-877.

28. Alabama NSAIDs Patient Safety Study:Independent Associations with Low Health Literacy

29. Age ≥ 65 Years Female Sex Read Written Medicine Info NSAID Risk Awareness At least some College Education Est. Adequate Health Literacy Path Model for Risk Awareness -0.293* -0.340* 0.345* 0.034 0.021 0.263* • * p<0.05 • Goodness of Fit Indices: • CFI = 1.000 • TLI = 1.000 • RMSEA = 0.000 1.390* 0.195*