Consumer Understanding and Use of Medication Guides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01731405
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : April 9, 2014
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University

Brief Summary:
The purpose of this study is to determine the potential efficacy of three revised Medication Guide layouts to increase consumers' comprehension

Condition or disease
Revised Medication Guide Formats

Detailed Description:

'Medication Guides' (Med Guides) are industry-developed documents that have been required by the Food and Drug Administration (FDA) to be issued to consumers for prescription medications that have been viewed to possess "serious and significant public health concerns" since 1998.1,2 These materials for consumers are intended to 1) provide specific dosing administration instructions that could prevent serious adverse effects associated with taking the medication, 2) warn individuals about significant health risks that could affect one's decision to take the medication, or 3) underscore the importance of taking the prescribed medication to the patient's health, and the need for proper adherence.

Despite their potential value in communicating safe and appropriate medication use, problems are clearly evident with the current template for Med Guides. Research conducted by this team in 2006 showed that the majority, if not all Med Guides dispensed with prescribed medicines are too complex and written at a reading grade level not suitable for the majority of patients to comprehend. As a result, these materials are usually ignored by consumers.3 Further research by this team investigating consumers' ability to process and correctly understand content contained in existing Med Guides found that, across all literacy levels, current Med Guides are poorly understood and ineffective in conveying safety information. Patients with low literacy comprehended significantly less, proving yet again that industry standards must be applied to improve these documents.

It is clear that the current guidance for Medication Guide development is insufficient, and the FDA is working to change that. Both the FDA and this research team have proposed multiple new Medication Guide formats, most of which are one-page cover sheets that highlight the most important information of the medication. To examine these new prototypes, this research team conducted six focus groups to obtain consumer-based feedback, and then evaluated three of the prototypes in an eye tracking study. Using the collective data from these two consumer-based studies, the investigators have further developed patient-centered and evidence-based Med Guide prototypes that will be more user-friendly, clear, usable, and low literacy appropriate.

In a cross-sectional, controlled trial, the investigators will investigate consumers' ability to process and correctly understand content contained in each of these top three new, redesigned prototypes.

The purpose of this research is to better understand how well people with varying levels of literacy understand information contained in three newly designed Med Guides. Through an in-person interview, the investigators aim to test consumers' ability to comprehend information contained in the guides by asking them retrieval and inference questions over the guides' content. This will allow us to compare the three formats against each other to see which prototype is most efficient in conveying the important information it is intended to convey. The investigators will recruit a total of 600 participants from general internal medicine clinics here in Chicago (Northwestern clinic = 300 participants and University of Illinois Chicago = 300 participants. A UIC RA will be responsible for this recruitment and will submit their own IRB for review).

This trial will field test our enhanced prototypes and allow us to compare them to each other, showing which format is best understood, especially in participants with low literacy.

Study Type : Observational
Actual Enrollment : 600 participants
Official Title: Consumer Understanding and Use of Medication Guides
Study Start Date : November 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : February 2014

Formats A,B,C; medicines Ritalin, Morphine Sulfate, Aranesp
All patients will see all 3 different formats of the Medication Guide prototypes. They will also see information for the same drugs, in the same order - Ritalin, Morphine Sulfate, and Aranesp. All participants see all the formats, the only thing that changes by participant is which format is in each medication. There will be 6 different randomized orders - A,B,C; A,C,B; B,C,A; B,A,C; C,A,B; C,B,A. So for example, A,B,C participants would see Ritalin in format A, Morphine Sulfate in format B, and Aranesp in format C.
There is not another group

Primary Outcome Measures :
  1. Functional Understanding and Comprehension [ Time Frame: 30 minute interview ]
    The primary outcome is to measure which of the three different formats of Medication Guides has the best participant comprehension, which we will assess based on total correct points out of total possible points.

Secondary Outcome Measures :
  1. Health Literacy (REALM) [ Time Frame: 30 minutes ]
    The REALM (Rapid Estimate of Adult Health Literacy in Medicine) is a word recognition test designed to provide a valid and quick assessment of participant health literacy.

  2. Participant Characteristics [ Time Frame: 30 minutes ]
    Basic demographic characteristics (age, sex, race/ethnicity), socioeconomic information (education, household income), health status information (self-reported overall health), and recent medication use will be collected by self report.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We are recruiting from 2 primary care clinics.

Inclusion Criteria:

  • 18 years or older
  • English speaking
  • Physically in the primary care clinic

Exclusion Criteria:

  • Under 18 years old
  • Non-English speaking
  • An uncorrectable hearing or a visual impairment which would hinder participants' ability to view the materials
  • Too ill to participate
  • Moderate to severe cognitive impairments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01731405

United States, Illinois
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Primary Care Plus
Chicago, Illinois, United States, 60636
Sponsors and Collaborators
Northwestern University
Principal Investigator: Michael S Wolf, PhD MPH Northwestern University

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael S. Wolf, Associate Professor, Northwestern University Identifier: NCT01731405     History of Changes
Other Study ID Numbers: ABT-5599
Abbott Laboratories ( Other Grant/Funding Number: Abbott Laboratories - 640-5310000-60025599-01 )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by Michael S. Wolf, Northwestern University:
Medication Guides

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents