- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592448
Investigation of Efficacy of Improved Acetaminophen Labeling
Consumer Understanding and Use of Non-Prescription Analgesics, Investigation of Efficacy of Improved Acetaminophen Labeling
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, United States, 30322
- The Emory Clinic
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Illinois
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Chicago, Illinois, United States, 60616
- Mercy Hospital
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Chicago, Illinois, United States, 60611
- Chicago LakeShore Medical Association
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-80 years old
- English speaking
Exclusion Criteria:
- Visual or hearing impairments
- Moderate to severe cognitive impairments
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.)
|
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.)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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40 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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40 minutes
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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.
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40 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael S. Wolf, PhD, MPH, Northwestern University
- Principal Investigator: Ruth M. Parker, MD, Emory University
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Am J Gastroenterol. 2008 Jan;103(1):255.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- McNeil-7247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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