Consumer Understanding and Use of Medication Guides
|ClinicalTrials.gov Identifier: NCT01731405|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : April 9, 2014
|Condition or disease|
|Revised Medication Guide Formats|
'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|
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731405
|United States, Illinois|
|Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611|
|Primary Care Plus|
|Chicago, Illinois, United States, 60636|
|Principal Investigator:||Michael S Wolf, PhD MPH||Northwestern University|