Clinical trial NCT01731405: Consumer Understanding and Use of Medication Guides
Official title: Consumer Understanding and Use of Medication Guides
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Revised Medication Guide Formats
Keywords: Medication Guides
FDA
Prototype
Format
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2012-11-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: We are recruiting from 2 primary care clinics.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Understanding and Comprehension
timeFrame: 30 minute interview
Secondary outcomes:
measure: Health Literacy (REALM)
timeFrame: 30 minutes
measure: Participant Characteristics
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Primary Care Plus
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael S Wolf, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Safonova TIa, Shelkovskii VI. [Nicotinamide coenzyme level in erythrocytes in children with cerebral paralysis]. Pediatriia. 1977 May;(5):71-3. No abstract available. Russian.
citation: 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.
citation: 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.