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

On September 14, 2009, Jeroan Allison made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (2.6 MB) (Plugin Software Help).

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/year2-3
  • 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 activation1,2
    • 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.
     

     

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    Alabama NSAIDs Patient Safety Study:
    Intensive Intervention

     

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    Alabama NSAIDs Patient Safety Study:
    Implementation Diagram

     

    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

     

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

     

    Slide 9

    
     

    Alabama NSAIDs Patient Safety Study:
    Physician Characteristics

     

    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

    12008 National Healthcare Disparities Report, AHRQ.
     

    • Racial/ethnic disparities well-documented
      • Access, quality, outcomes
      • Important gaps remain, despite selective narrowing1
    • Little known about NSAID disparities
      • Risk awareness
      • Use
      • Outcomes

     

    Slide 12

    
     

    Alabama NSAIDs Patient Safety Study:
    NSAID Risk Awareness

    Follow up, n = 383
     

     

    Slide 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.
     

     

    Slide 14

    
     

    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.
     

     

    Slide 15

    
    The Rheumatologist. 2(5) May 2008.
     

     

    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

    1 US 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

    *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

    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
     

    p< 0.001
     

     

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    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
     

     

    Slide 28

    
     

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

     

    Slide 29

    
     

    Path Model for Risk Awareness