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Completed

NCT Number: NCT01592448

Investigation of Efficacy of Improved Acetaminophen Labeling

The purpose of this study is to evaluate, through brief, one-on-one cognitive interviews, the efficacy of 'enhanced' acetaminophen messages and icons in improving consumer understanding and use of prescription (Rx) and non-prescription (over-the-counter, OTC) acetaminophen containing products compared to the current standard.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Grady Memorial Hospital, Atlanta, Georgia, United States

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About this study

Acetaminophen is a pain reliever and fever reducer found in many over-the-counter (OTC) analgesics as well as prescription (Rx) products commonly prescribed at discharge from the emergency department. 1 An estimated 36% of Americans ingest acetaminophen at least once a month.1, 2 While acetaminophen is generally safe and effective when used at recommended doses, acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure (ALF) in the United States.2-4 Moreover, one half to two-thirds of overdoses leading to acute liver failure are unintentional, suggesting the root cause may be poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage.2-4 On-going studies by this research group have shown patient misunderstanding of dosing instructions and warnings associated with OTC medicines to be prevalent.

It has also been suggested that patients receiving prescription medications containing acetaminophen may not be informed or aware of the potential risk of acetaminophen overuse when taking prescription products in combination with over-the-counter pain relievers.1 This is supported by the finding that a third of narcotic users were simultaneously using an OTC acetaminophen containing product in a multicenter study of ALF cases.2 To address the growing concern of acetaminophen misuse, in June 2009 the US Food and Drug Administration (FDA) convened a panel to discuss the maximum dose recommendations of acetaminophen found in OTC medications. The panel concluded that there was a notable lack of available evidence on consumer understanding and use of over-the-counter acetaminophen products. Studies are needed to explore patients' 1) knowledge of potential acetaminophen overdose when using prescription analgesics simultaneously with non-prescription acetaminophen and 2) avenues available to increase awareness of potential acetaminophen overdose from misuse of both OTC and Rx acetaminophen containing medicines.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years old
  • English speaking

Exclusion criteria

  • Visual or hearing impairments
  • Moderate to severe cognitive impairments

Treatment and study plan

Active Ingredient Icon

Behavioral

Enhanced bottles will have a symbol, or icon, designed to draw attention to active ingredient information. The icon is a black hexagon containing two letters denoting the active ingredient of the medication (i.e. "Ac" for acetaminophen). Over-the-counter bottles will have the icon placed on the front of the bottle next to active ingredient information and on the back of the bottle in the drug facts to the left of the active ingredient information. Prescription bottles will have the icon placed below the directions for how to take the medication and will be accompanied by a brief statement indicating the medicine contains acetaminophen.

Primary outcomes

  1. Functional Understanding and Use

    Time frame: 40 minutes

    Functional understanding (via teachback and demonstration) of acetaminophen label information (OTC & Rx), including 1) active ingredient, 2) maximum daily dose, and 3) risks associated with misuse.

Secondary outcomes

  1. Health literacy (NVS)

    Time frame: 40 minutes

    The NVS (Newest Vitals Sign) is designed to provide a valid and quick assessment of participant health literacy. The assessment is based on a nutrition label from an ice cream container. Patients are given the label and then asked 6 questions about it.

  2. Participant characteristics

    Time frame: 40 minutes

    Basic demographic characteristics (age, sex, race/ ethnicity), socioeconomic information (education, household income), health status information (self-reported overall health), recent medication use and beliefs about over-the-counter medicines will be collected.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Emory University
  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Registry information

Official study title

Consumer Understanding and Use of Non-Prescription Analgesics, Investigation of Efficacy of Improved Acetaminophen Labeling

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 7, 2012
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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