NSAID Risk Communication: Findings from the Alabama NSAID Patient Safety Study

Slides

Slide 1

 

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

Slide 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/year^2-3
  • GI/CV risks well known
  • Renal risks less well known
  • Frequent unsafe prescribing

¹ The Harris Poll: National Consumer's League; 2003
² Tarone. American Journal of Therapeutics. 2004; 11(1):17-25.
³ Singh. Journal of Rheumatology. 1999;26(Supl 56):18-24.
⁴ Lanas. American Journal of Gastroenterology. 2005;100(8):1685-93.

Slide 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

Slide 4

Alabama NSAIDs Patient Safety Study: Intervention Components

• • Standard
    • CME modules
    • NSAID monographs from ASHP
  • Enhanced
    • Point-of-care, paper-based patient tool
    • Patient activation^1,2
    • Shared decision making³
    • Low literacy appropriate

¹ Roter. Patient Education & Counseling. 2001; 44(1):79-86.
² Cohen. Preventive Medicine. 1994; 23(3):284-91.
³ Weed. Your Heal Care and How to Manage It. Essex Publishing, Vermont. 1975.

Slide 5

Alabama NSAIDs Patient Safety Study: Intensive Intervention

Images: Two different posters warning patients of NSAIDS medication side effects.

Slide 6

Alabama NSAIDs Patient Safety Study: Implementation Diagram

Image of a timeline flowchart.

The top says "Primary Care Physicians".

June 2005-April 2006: Baseline Assessment

May 2006: CME or Combined Intervention

June 2006-2007: Follow-up Assessment for both CME and Combined Intervention

Slide 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

Slide 8

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

n = 786; response rate = 73%

Slide 9

Alabama NSAIDs Patient Safety Study: Physician Characteristics 

n = 43; retention rate = 84%

Slide 10

Alabama NSAID Patient Safety Study: Presentation Overview

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

Slide 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.

Slide 12

Alabama NSAIDs Patient Safety Study: NSAID Risk Awareness

Bar graph showing NSAID Risk Awareness Score, Potential NSAID Risks, HTN, kidney,GI, MI

0 = 23.0%
1 = 27.7%
2 = 22.5%
3 = 16.5%
4 = 10.4%

Follow up, n = 383

Slide 13

Alabama NSAIDs Patient Safety Study: Racial/ethnic Disparities

Bar chart showing awareness by race. Whites show a higher awareness of risks for all types.

Baseline, n = 404; p < 0.05 for all.
Fry et al. Arthritis Rheum. 2007 Dec 15;57(8):1539-45.

Slide 14

Alabama NSAIDs Patient Safety Study: Patient-Pharmacist Communication

Bar chart showing success rates by sex.  White males have a higher success rate than white females.

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

Slide 15

Image of the top of an article entitled: "Rheum and Race: Where Are We?"

Slide 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.

Slide 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.

Slide 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

Slide 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

Slide 20

Alabama NSAID Patient Safety Study: Presentation Overview

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

Slide 21

Alabama NSAIDs Patient Safety Study: Over-time Changes

Bar chart showing improvement in NSAID risk awareness from a baseline time to a follow-up study.

*p < 0.001
 

Slide 22

Alabama NSAID Patient Safety Study: Presentation Overview

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

Slide 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

Slide 24

Supplementary Slides

Slide 25

Alabama NSAIDs Patient Safety Study: Health Literacy and Health Status

Bar chart showing health status ratings for patients with low health literacy. 

Poor: 41% 

Fair: 13%

Good: 6%

Very good: 7%

Excellent: 6%

p < 0.001

Health status from, "How would you rate your overall health?"
Low health literacy defined as levels 1 or 2 from single Chew question.

Slide 26

Alabama NSAIDs Patient Safety Study: NSAID Risk Awareness by Health Literacy for Patients Age ≥ 65 Years

Bar chart showing risk awareness by literacy level from 1 (poor) to 5 (excellent). 

1: 50%

2: 73%

3: 82%

4: 85%

5: 88%

p < 0.001

Slide 27

Alabama NSAIDs Patient Safety Study: Estimated Health Literacy

Bar chart showing results of asking the question: "How confident are you in filling out medical forms by yourself?"

Results:

Not at all: 6.8%

A little: 5.3%

Somewhat: 13.3%

Quite a bit: 26.7%

Extremely: 57.2%

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

Slide 28

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

¹c-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

Slide 29

Path Model for Risk Awareness

Flow chart showing model for risk awareness showin statistical goodness of fit indices.