Investigation of Efficacy of Improved Acetaminophen Labeling

This study has been completed.
Sponsor:
Collaborators:
Emory University
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University
ClinicalTrials.gov Identifier:
NCT01592448
First received: November 28, 2011
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Acetaminophen Overdose
Pain
Behavioral: Active Ingredient Icon

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Consumer Understanding and Use of Non-Prescription Analgesics, Investigation of Efficacy of Improved Acetaminophen Labeling

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Functional Understanding and Use [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Health literacy (NVS) [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    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.

  • Participant characteristics [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 662
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Usual Care
Participants will be shown "standard" (defined as currently commercially available) over-the-counter and prescription medicine bottles and asked questions regarding safety and use. Participants will also be shown additional "standard" over-the-counter bottles and asked whether these comparison bottles could safely be taken in addition to the primary products shown.
Written Orientation
Participants will be exposed to over-the-counter and prescription bottles "enhanced" with an icon pertaining to active ingredient and asked questions regarding safety and use. Participants will be exposed to a flier describing the safe use of acetaminophen and orienting the participant towards the icon that is used to indicate the presence of acetaminophen in a product. This flier will be passively hanging within sight of the participant in the room, but no verbal explanation of the flier will be given to the participant. (This is designed to represent a passive education campaign such as posters in drug stores that may be used should these icons be adopted by manufacturers.)
Behavioral: Active Ingredient Icon
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.
Written + Verbal Orientation
Participants will be exposed to over-the-counter and prescription bottles "enhanced" with an icon pertaining to active ingredient and asked questions regarding safety and use. Participants will be exposed to a flier describing the safe use of acetaminophen and orienting the participant towards the icon that is used to indicate the presence of acetaminophen in a product. Research personnel will also verbally go through the flier with the participant and answer any questions in a standardized fashion. (This is designed to represent an active education campaign such as pharmacist counseling that may be used should these icons be adopted by manufacturers.)
Behavioral: Active Ingredient Icon
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Two types of practices - an academic general medicine clinic and the other a community health center - will serve as performance sites.

Criteria

Inclusion Criteria:

  • 18-80 years old
  • English speaking

Exclusion Criteria:

  • Visual or hearing impairments
  • Moderate to severe cognitive impairments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592448

Locations
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Illinois
Chicago LakeShore Medical Association
Chicago, Illinois, United States, 60611
Mercy Hospital
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Northwestern University
Emory University
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Principal Investigator: Michael S. Wolf, PhD, MPH Northwestern University
Principal Investigator: Ruth M. Parker, MD Emory University
  More Information

Publications:
Responsible Party: Michael S. Wolf, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01592448     History of Changes
Other Study ID Numbers: McNeil-7247
Study First Received: November 28, 2011
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Acetaminophen
Patient Safety
Health Literacy

Additional relevant MeSH terms:
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 14, 2014