NSAID Risk Communication:
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Nsaids

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


Nsaids

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


Alabama nsaid patient safety study goals

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

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

Alabama NSAIDs Patient Safety Study:Intensive Intervention

5


Alabama nsaids patient safety study implementation diagram

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


Alabama nsaids patient safety study implementation detail

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


Alabama nsaids patient safety study baseline follow up patient population

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


Alabama nsaids patient safety study physician characteristics

Alabama NSAIDs Patient Safety Study:Physician Characteristics


Alabama nsaid patient safety study presentation overview

Alabama NSAID Patient Safety Study: Presentation Overview

  • Patient-clinician communication by race/ethnicity

  • Patient risk understanding and literacy

  • Randomized trial

  • Conclusions


Alabama nsaids patient safety study racial ethnic disparities

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.


Alabama nsaids patient safety study nsaid risk awareness

Alabama NSAIDs Patient Safety Study:NSAID Risk Awareness

Follow up, n = 383


Alabama nsaids patient safety study racial ethnic disparities1

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.


Alabama nsaids patient safety study patient pharmacist communication

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.


Nsaids

The Rheumatologist. 2(5) May 2008.


Alabama nsaid patient safety study presentation overview1

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

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

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


Alabama nsaids patient safety study health literacy findings

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


Alabama nsaid patient safety study presentation overview2

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

Alabama NSAIDs Patient Safety Study:Over-time Changes

*p < 0.001


Alabama nsaid patient safety study presentation overview3

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

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

Supplementary Slides


Alabama nsaids patient safety study health literacy and health status

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.


Nsaids

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

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.


Alabama nsaids patient safety study independent associations with low health literacy

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


Path model for risk awareness

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*


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