Consumer Understanding and Use of Medication Guides

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation
    • Chicago, Illinois, United States, 60636
      • Primary Care Plus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We are recruiting from 2 primary care clinics.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Understanding and Comprehension	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.	30 minute interview

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Literacy (REALM)	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.	30 minutes
Participant Characteristics	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.	30 minutes

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Abbott
• Investigators: Principal Investigator: Michael S Wolf, PhD MPH, Northwestern University

Publications and helpful links

General Publications

• Tsfasman IM, Starovoitov II, Ziakun AM, Skriabin GK. [Study of the initial reaction of enzymatic oxidation of 1,8-dimethylnaphthalene]. Biokhimiia. 1976 May;41(5):864-8. Russian.
• Wolf MS, King J, Wilson EA, Curtis LM, Bailey SC, Duhig J, Russell A, Bergeron A, Daly A, Parker RM, Davis TC, Shrank WH, Lambert B. Usability of FDA-approved medication guides. J Gen Intern Med. 2012 Dec;27(12):1714-20. doi: 10.1007/s11606-012-2068-7. Epub 2012 May 8.
• Wallace LS, Roskos SE, Weiss BD. Readability characteristics of consumer medication information for asthma inhalation devices. J Asthma. 2006 Jun-Jul;43(5):375-8. doi: 10.1080/02770900600709856.
• Safonova TIa, Shelkovskii VI. [Nicotinamide coenzyme level in erythrocytes in children with cerebral paralysis]. Pediatriia. 1977 May;(5):71-3. No abstract available. Russian.
• Bull C, Goncher G, Deutschman CS, Hoffman BM. Source of residual Bohr effect in hemoglobin oxidation. J Biol Chem. 1977 May 25;252(10):3128-30.
• Wolf MS, Bailey SC, Serper M, Smith M, Davis TC, Russell AL, Manzoor BS, Belter L, Parker RM, Lambert B. Comparative effectiveness of patient-centered strategies to improve FDA medication guides. Med Care. 2014 Sep;52(9):781-9. doi: 10.1097/MLR.0000000000000182.

Helpful Links

• Federal Register (FDA-2010-N-0184). Experimental Study of Patient Information Prototypes.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: FDA; Medication Guides; Prototype; Format
• Other Study ID Numbers: ABT-5599; Abbott Laboratories (Other Grant/Funding Number: Abbott Laboratories - 640-5310000-60025599-01)