A Universal Medication Schedule to Promote Patient Understanding and U

Slide Presentation from the AHRQ 2009 Annual Conferenc

Slide presentation from the AHRQ 2009 conference.

Slide Presentation from the AHRQ 2009 Annual Conference

On September 15, 2009, Michael Wolf made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (1.8 MB) (Plugin Software Help).

Slide 1


 

A Universal Medication Schedule to promote patient understanding and use

Michael Wolf, PhD MPH
Northwestern University

Terry Davis, PhD
Louisiana State University Health Sciences Center-Shreveport

Ruth Parker, MD
Emory University

Will Shrank, MD
Harvard Medical School

Slide 2


 

Acknowledgements

  • Primary Support: R01 HS017687 (AHRQ; Enhanced drug label design to improve patient understanding and use; PI: Wolf)
  • Disclosure: Target Corporation Research Grant
  • Partners: Alastair Wood, MD; JoAnn Knox, MSW
  • Research Staff: Anjali Pandit, MPH; Ashley Bergeron, BA; Pear Moraras, BA

Slide 3


 

Overview

  • Health Literacy & Drug Labeling: a 60-second review.
  • An Evidence-based, Patient-Centered Label Design
  • Field Test Results
  • The 'UMS Trial'—Methods & Rationale
  • Next Steps

 

Slide 4


 

Health Literacy & Drug Labeling

 

Slide 5


 

An image of a person is shown.

 

Slide 6


 

Image: Two people are shown. The left image is labeled MD/RN.

 

Slide 7


 

An image of a person and a prescription are shown.

 

Slide 8


 

An image of a person and an image of pharmacy counter are shown.

 

Slide 9


 

An image of a person and an image of barcode label are shown.

 

Slide 10


 

An image of a person and an image of medication bottle are shown.

 

Slide 11


 

An image of a person and an image of labels on medication bottle are shown.

 

Slide 12


 

An image of a person and an image of Wellitol are shown.

 

Slide 13


 

An image of a person and an image of FDA Web site are shown.

 

Slide 14


 

An image of a person and an image of the physician's desk reference are shown.

 

Slide 15


 

An image of a person and an image of the AARP guide to pills are shown.

 

Slide 16


 

Images of a person and of people talking are shown.

 

Slide 17


 

Image: A person with preceding concepts encircling him/her is shown.

 

Slide 18


 

Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

  • Tangible
  • Brief
  • Repeatedly used
  • Only source for many

 

Slide 19


 

Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

  • Tangible
  • Brief
  • Repeatedly used
  • Only source for many

 

Slide 20


 

Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

  • Tangible
  • Brief
  • Repeatedly used
  • Only source for many

 

Slide 21


 

Value of Rx Labels

Image: A person with preceding concepts encircling him/her is shown.

  • Tangible
  • Brief
  • Repeatedly used
  • Only source for many

<10% read them

Source: Wolf, et al. Am J Health Sys Pharm, 2006

 

Slide 22


 

Evidence Available.

  • Group label content
  • Emphasize patient info (Rx name, patient name, directions, indication*)
  • Write instructions using explicit time intervals (UMS)
  • Use numeric vs. alpha characters for dose, frequency
  • Separate times with virtual 'carriage returns'
  • Provide a visual aid to reinforce the 'sig' instruction

Value in Standardization!

 

Slide 23


 

An Enhanced Label and 'UMS'

Image: Sample label for patient Michael Wolf, containing UMS dosage directions.

 

Slide 24


 

Efficacy Trial

  • Comprehension testing
  • 4 clinics in two sites (Chicago, Shreveport); 1 academic, 1 FQHC
  • Sample = 500 primary care patients >18 years of age
  • Sequential assignment to standard, UMS, UMS + graphic
  • Outcome: Functional understanding of 3 hypothetical regimens

 

Slide 25


 

Study Arms

StandardUMSUMS + Graphic Aid
Take one tablet by mouth daily.Take 1 tablet at bedtime.Image shows table with 4 sections, morning, noon, evening, and bedtime. Morning, noon, evening are blacked out; there is a "1" under bedtime.
Take one tablet by mouth three times daily.Take
1 tablet in the morning
1 tablet at noon
1 tablet in the evening
 		Image shows table with 4 sections, morning, noon, evening, and bedtime. There is a "1" under the morning, noon, evening sections; bedtime is blacked out.
Take two tablet by mouth twice daily.Take
2 tablets in the morning,
And 2 tablets at bedtime		Image shows table with 4 sections, morning, noon, evening, and bedtime. Noon and evening are blacked out; there is a "2" under the morning and bedtime sections.

 

Slide 26


 

Findings.

  • 91% of patients correctly interpreted UMS instructions
  • Benefit strongest with more complex regimens (%):
  • GEE Model: greater comprehension of UMS instructions vs. standard label instructions (ARR 1.33, 95% CI 1.25-1.41; p<0.001)
  • Addition of Graphic Aid of limited value for single drug review (ARR 0.93, 95% CI 0.89-0.97; p<0.001)
  • Improvement for 2 or 3x daily schedules (40% of US prescriptions)

 

Slide 27


 

Findings (cont.)

  • Impact of limited literacy mitigated (REALM—low (n=101): ARR 0.95, 95% CI 0.86—1.04; p=0.25)
  • Significant interactions found—Patients w/ low literacy had greatest benefit from the UMS (ARR 1.39, 95% CI 1.14-1.68, p<0.001)
  • Regimen complexity and UMS—greater complexity, greater benefit (ARR 2.00, 95% CI 1.44-2.42, p<0.001)

 

Slide 28

Present Study. Text Description is below the image.
 

Present Study—the 'UMS' trial

Objective: to test the effectiveness of the evidence-based, enhanced prescription drug container label design to improve patients' understanding of instructions for use.

Slide 29


 

Methods.

  • Actual Use Assessment
  • 11 Safety Net Clinics, 1 Central-Fill Pharmacy (Va.)
  • Sample = 960 Diabetic/Hypertensive Patients, > 30 years of age
  • Random Assignment to Enhanced vs. Standard Label (all meds)
  • Assessment: Baseline, 3 months, 1 Year
  • Outcomes:
    • Functional Understanding
    • Adherence (self-report, pill count, refill data)
    • HBA1C/Blood Pressure

 

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In Progress.

  • 5 clinics activated.
  • 335 patients identified, 131 recruited to study. Response rate 67%.
  • Lessons learned:
    • Patients navigating multiple pharmacies for meds
    • Current pharmacy software (PDX) has significant limitations
      • I) Hard coding of 'sig' font and size
      • Ii) Position of sig, indication, etc.
      • Iii) Emphasis options
      • Iv) Auxiliary warnings
  • Broader issues (evidence for warnings, other label elements, ethics)

Slide 31


 

PRN.

  • Current study emphasis 1) solid pill-form, 2) non-PRN
  • UMS graphic blocked out for PRN drugs.
  • Best practice?
Take 1-2 tablets by mouth every 4-6 hours as needed for pain.

Take: 1 or 2 pills for pain.

Wait at least 4 hours before you take it again.

Do NOT take more than 8 pills in a day.

 

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Next Steps

  • 3 month interviews (w/ adherence outcomes) have begun
  • Remaining clinics to be engaged in systematic manner
  • Orient, teach use of the UMS (and graphic aid) to patients?
  • Need repeatedly identified for language concordant services
    • Supplement in California Endowment grant
  • Work with others (i.e. USP) on...
    1. Auxiliary instructions
    2. Standard label content
    3. Required format (i.e. PDX issue)

Slide 33


 

Contact Information:

Michael S. Wolf, PhD MPH
Associate Professor, Medicine & Learning Sciences
Associate Division Chief—Research
Division of General Internal Medicine
Northwestern University
Feinberg School of Medicine
750 N. Lake Shore Drive, 10th Floor
Chicago, IL 60611
(312) 503—5592
mswolf@northwestern.edu

Current as of December 2009
Internet Citation: A Universal Medication Schedule to Promote Patient Understanding and U: Slide Presentation from the AHRQ 2009 Annual Conferenc. December 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/events/conference/2009/wolf/index.html