Clinical trial NCT01592448: Investigation of Efficacy of Improved Acetaminophen Labeling
Official title: Consumer Understanding and Use of Non-Prescription Analgesics, Investigation of Efficacy of Improved Acetaminophen Labeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetaminophen Overdose
Pain
Keywords: Acetaminophen
Patient Safety
Health Literacy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Emory University
name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2012-05-07
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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 criteria: Inclusion Criteria:

* 18-80 years old
* English speaking

Exclusion Criteria:

* Visual or hearing impairments
* Moderate to severe cognitive impairments

Primary outcomes:
measure: Functional Understanding and Use
timeFrame: 40 minutes
Secondary outcomes:
measure: Health literacy (NVS)
timeFrame: 40 minutes
measure: Participant characteristics
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: Chicago LakeShore Medical Association
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael S. Wolf, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Ruth M. Parker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.