Investigation of Efficacy of Improved Acetaminophen Labeling

NCT01592448 | Completed DMC

• 1 other identifier: McNeil-7247
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Acetaminophen Overdose; Pain

Keywords

Acetaminophen; Patient Safety; Health Literacy

Outcome Measures

Primary Outcomes (1)

• Functional Understanding and Use

  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.

  40 minutes

Secondary Outcomes (2)

• Health literacy (NVS)

  40 minutes

• Participant characteristics

  40 minutes

Study Arms (3)

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

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

Interventions

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.

Written + Verbal Orientation; Written Orientation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years old
• English speaking

You may not qualify if:

• Visual or hearing impairments
• Moderate to severe cognitive impairments

Sponsors & Collaborators

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

Study Sites (4)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Chicago LakeShore Medical Association

Chicago, Illinois, 60611, United States

Location

Mercy Hospital

Chicago, Illinois, 60616, United States

Location

Related Publications (4)

• Fosnocht D, Taylor JR, Caravati EM. Emergency department patient knowledge concerning acetaminophen (paracetamol) in over-the-counter and prescription analgesics. Emerg Med J. 2008 Apr;25(4):213-6. doi: 10.1136/emj.2007.053850.

  PMID: 18356351 BACKGROUND

• Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS, Reisch JS, Schiodt FV, Ostapowicz G, Shakil AO, Lee WM; Acute Liver Failure Study Group. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005 Dec;42(6):1364-72. doi: 10.1002/hep.20948.

  PMID: 16317692 BACKGROUND

• Bower WA, Johns M, Margolis HS, Williams IT, Bell BP. Population-based surveillance for acute liver failure. Am J Gastroenterol. 2007 Nov;102(11):2459-63. doi: 10.1111/j.1572-0241.2007.01388.x. Epub 2007 Jun 29.

  PMID: 17608778 BACKGROUND

• Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SH, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM; U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002 Dec 17;137(12):947-54. doi: 10.7326/0003-4819-137-12-200212170-00007.

  PMID: 12484709 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael S. Wolf, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Ruth M. Parker, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: May 7, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

US (4)