NSAID Risk Communication:Findings from the

Alabama NSAID Patient Safety Study

Jeroan 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, PhD

Sept 14, 2009

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; 20032Tarone. 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

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

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.

Alabama NSAIDs Patient Safety Study:Intensive Intervention

5

Alabama NSAIDs Patient Safety Study:Implementation Diagram

Primary Care Physicians

R

Baseline Assessment

CMECombined Intervention

Follow-up Assessment

Follow-up Assessment

June 2005–

April 2006

May 2006

June 2006 –

Feb 2007

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

Patient Characteristics %

Age > 65 years 68.2

Female 73.0

African American 35.2

Poor/fair health 42.0

College degree 16.7

Annual household income < $25k 68.9

n = 786; response rate = 73%

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

Physician Characteristics %

Age < 50 years 48.8

Female 27.0

Race/ethnicity

• African American 27.9

• White 53.5

Specialty

• Family Medicine 48.8

• Internal Medicine 48.8

International graduate 20.5

n = 43; retention rate = 84%

Alabama NSAIDs Patient Safety Study:Physician Characteristics

Alabama NSAID Patient Safety Study: Presentation Overview

• Patient-clinician communication by race/ethnicity• Patient risk understanding and literacy • Randomized trial• Conclusions

• 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.

Alabama NSAIDs Patient Safety Study:Racial/ethnic Disparities

Alabama NSAIDs Patient Safety Study:NSAID Risk Awareness

Follow up, n = 383

Baseline, n = 404; p < 0.05 for all.

Alabama NSAIDs Patient Safety Study:Racial/ethnic Disparities

Fry et al. Arthritis Rheum. 2007 Dec 15;57(8):1539-45.

Alabama NSAIDs Patient Safety Study:Patient-Pharmacist Communication

LaCavita et al. J AM Pharm Assoc. 2009; 49: 110-5.Baseline and follow up, n = 687; *p < 0.001.

The Rheumatologist. 2(5) May 2008.

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.

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.

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

• 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

Alabama NSAIDs Patient Safety Study:Health Literacy Findings

Alabama NSAID Patient Safety Study: Presentation Overview

• Study Overview• Patient-clinician communication by race/ethnicity• Patient risk understanding and literacy • Randomized trial• Conclusions

Alabama NSAIDs Patient Safety Study:Over-time Changes

*p < 0.001

Alabama NSAID Patient Safety Study: Presentation Overview

• Study Overview• Patient risk understanding by literacy • Patient-clinician communication by race/ethnicity• Randomized trial• Conclusions

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

Supplementary Slides

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.

Alabama NSAIDs Patient Safety Study:NSAID Risk Awareness by Health Literacy

for Patients Age ≥ 65 Years

p< 0.001

Alabama NSAIDs Patient Safety Study: Estimated Health Literacy

“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.

Follow up, n = 383

Model 1 Model 21

OR 95% CI OR 95% CI

African American2 2.54 1.32 – 4.87 1.68 0.78 – 3.64

Age (10-year) 1.62 1.19 – 2.19 1.57 0.11 – 2.23

Female 0.25 0.13 – 0.48 0.16 0.07 – 0.35

Any college 0.06 0.13 – 0.25

Adequate income 0.22 0.10 – 0.471c-statistic: 0.87 (0.82 – 0.92)2Effect explained: 0.58 (0.14 – 1.00)Low health literacy defined as levels 1 or 2 from Chew question

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

Path Model for Risk Awareness

NSAID Risk Awareness

Read Written Medicine Info

Est. Adequate Health Literacy

At least someCollege Education

Age ≥ 65 Years

Female Sex

-0.293*-0.293*

0.345*0.345*

0.0210.021

0.263*0.263*

1.390*1.390* 0.195*0.195*

-0.340*-0.340*

* p<0.05* p<0.05Goodness of Fit Indices:Goodness of Fit Indices:

• CFI = 1.000CFI = 1.000• TLI = 1.000TLI = 1.000• RMSEA = 0.000RMSEA = 0.000

0.0340.034