NSAID Risk Communication: Findings from the Alabama NSAID Patient Safety Study Jeroan Allison, Erik

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NSAID Risk CommunicationFindings 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
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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 Consumers 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.
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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

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Alabama NSAIDs Patient Safety StudyIntervention
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.
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Alabama NSAIDs Patient Safety StudyIntensive
Intervention
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Alabama NSAIDs Patient Safety StudyImplementatio
n Diagram
Primary Care Physicians
Baseline Assessment
June 2005 April 2006
R
May 2006
Combined Intervention
CME
Follow-up Assessment
June 2006 Feb 2007
Follow-up Assessment
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Alabama NSAIDs Patient Safety StudyImplementatio
n 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 StudyBaseline
Follow Up Patient Population
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Alabama NSAIDs Patient Safety StudyPhysician
Characteristics
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Alabama NSAID Patient Safety Study Presentation
Overview

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

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Alabama NSAIDs Patient Safety StudyRacial/ethni
c 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.
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Alabama NSAIDs Patient Safety StudyNSAID
Risk Awareness
Follow up, n 383
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Alabama NSAIDs Patient Safety StudyRacial/ethni
c Disparities
Baseline, n 404 p lt 0.05 for all.
Fry et al. Arthritis Rheum. 2007 Dec
1557(8)1539-45.
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Alabama NSAIDs Patient Safety StudyPatient-Phar
macist Communication
Baseline and follow up, n 687 p lt 0.001.
LaCavita et al. J AM Pharm Assoc. 2009 49
110-5.
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The Rheumatologist. 2(5) May 2008.
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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.
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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.
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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

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Alabama NSAIDs Patient Safety StudyHealth
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

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Alabama NSAID Patient Safety Study Presentation
Overview

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

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Alabama NSAIDs Patient Safety StudyOver-time
Changes
p lt 0.001
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Alabama NSAID Patient Safety Study Presentation
Overview

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

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Alabama NSAIDs Patient Safety StudyRisk
Awareness, Communication, Behavior

• Important gaps
• Patient dont understand risk
• Physicians/pharmacists dont 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

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Supplementary Slides
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Alabama NSAIDs Patient Safety StudyHealth
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.
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Alabama NSAIDs Patient Safety StudyNSAID Risk
Awareness by Health Literacy for Patients Age
65 Years
plt 0.001
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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.
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Alabama NSAIDs Patient Safety StudyIndependent
Associations with Low Health Literacy
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Path Model for Risk Awareness
-0.293
-0.340
0.345
0.034
0.021
0.263

• plt0.05
• Goodness of Fit Indices
• CFI 1.000
• TLI 1.000
• RMSEA 0.000

1.390
0.195