Understanding Patient's Knowledge and Use of Acetaminophen

Introduction to Study Objectives:

In a joint collaboration of the Centers for Education and Research on Therapeutics (CERTS) at The University of Pennsylvania and the M.D. Anderson Cancer Center, this study proposes to a) combine detailed but under-utilized existing large datasets and b) collect new primary data; together, resulting two data resources will advance our ability to describe, study, and understand the effectiveness and safety of pharmaceuticals received by pediatric patients in hospitals, and how to improve the safe use of over-the-counter (OTC) acetaminophen in home settings.

The CERTS study is organized into two projects: Project I and Project II.

For this protocol, the study focus will be Project II-Phase 1.

Project II will seek to qualitatively describe the patterns of use and misuse of over-the-counter OTC acetaminophen, through information gathered from consumers of various age groups, as well as professional key informants.

Project II-Phase 1

Objective 1:

-Qualitatively explore knowledge, attitudes, beliefs, and practices regarding adult and adolescent self-administration of OTC acetaminophen, and parental administration of OTC acetaminophen to children.

Objective 2:

-Qualitatively explore experiences and practices of key professional informants, including physician and pharmacists, with respect to communicating information on the administration and risks of OTC acetaminophen to consumers and patients.

Study Overview

• Status: Unknown
• Conditions: Liver Failure
• Intervention / Treatment: Behavioral: Focus Groups; Behavioral: Personal Interviews

Detailed Description

Individual Interviews:

If you agree to take part in this study, you will take part in individual interview session. The interviews will be conducted by phone and audiotaped (recorded) and transcribed (typed) by the research staff at M. D. Anderson.

You will be asked a series of questions about your knowledge of acetaminophen, views about the packaging, beliefs about the benefits and risks of taking acetaminophen, and when and how often you use acetaminophen. You will also be asked about what you have heard from other people about using acetaminophen and what types of experiences other people that you talked to about acetaminophen have had. The interview should last about 30 minutes.

To protect your confidentiality, only first names will be used during the interview sessions. Your name and any identifiable information will be removed when the audio recordings are typed. The audio recordings will be stored in a password protected file that only the study chair and research staff will have access to. The audio recordings will be destroyed by the researchers once study results have been published.

Length of Study:

Your participation in this study will be over after the interview is complete.

This is an investigational study.

Up to 124 people will be enrolled in this multicenter study. All will be enrolled by M. D. Anderson research staff. Participants will be recruited from outpatient pediatrics and primary care clinics at Kelsey-Seybold and Harris County Hospital District.

Focus Group Session:

The focus group session will be led by a trained interviewer. There will also be a research staff member present. During the focus group sessions, the interviewer will ask the group questions about acetaminophen, the directions on the packaging, beliefs about the benefits and risks of taking acetaminophen, and when and how often you use acetaminophen. Each focus group session should last about 90-120 minutes and will have 6-8 participants. The study chair will decide which focus group you will participate in.

You will take part in one of the following groups:

• Parents of children less than 8 years old will meet to talk about how acetaminophen is given to children.
• Adults will meet to talk about your beliefs about the benefits and risks of taking acetaminophen, how you take acetaminophen, and how often you take acetaminophen.

The focus group sessions will be audiotaped (recorded) and transcribed (typed) by the research staff at M. D. Anderson. To protect your confidentiality, only first names will be used during the focus group sessions and names will be coded when typed. The audio recordings will be destroyed by the researchers once study results have been published.

Length of Study:

Your participation on this study will be over when the focus group session is complete.

This is an investigational study. Up to 124 people will be enrolled in this multicenter study. All will be enrolled by M. D. Anderson research staff. Participants will be recruited from outpatient pediatrics and primary care clinics at Kelsey-Seybold and Harris County Hospital District.

• Study Type: Observational
• Enrollment (Anticipated): 124

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia, University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Harris County Hospital District Outpatient Clinics
    • Houston, Texas, United States, 77030
      • Kelsey Seybold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Parents of young children (8 years of age or younger) who administered acetaminophen to their children, Adults and Adolescents (aged 13-20 years of age) familiar with or used OTC acetaminophen in the last 2 years, and Primary care physicians and Pharmacists. All Houston, Texas residents.

Description

Inclusion Criteria:

1. English or Spanish language proficiency.
2. Residence in Metropolitan Houston, Texas.
3. Adequate cognition as determined by the research staff through the use of questions related to orientation about person, time and place.
4. Adolescents who are 13 to 20 years of age who have ever heard of over-the-counter medication (We will recruit 20 adolescents through their parents, who will be required to give consent before the study staff contacts the child);or parents of children (either a mother or a father, but only one parent per family) under 8 years of age who have ever given their children an over- the-counter medication; or adults (21 years of age or older) who have used over-the-counter medication in the past 2 years.
5. Primary care physicians will be Family Practitioners or General Internist, with an active Texas license, who devote at least 50% of their time to clinical practice.
6. Pharmacists will hold a PharmD degree and licensure in the state of Texas and work at least half-time in a community pharmacy setting.

Exclusion Criteria:

1. Participants who do not give informed consent.
2. A parent whose spouse/partner is/has already participated in the focus group.
3. Pharmacists actively enrolled in a training program.
4. Physicians who are participating in a fellowship or residency training program.
5. Children who may be depressed or at risk of suicide or managing that risk.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Parents of children under 8 years of age who have ever given their children an over- the-counter medication.	Behavioral: Focus Groups; 6 to 8 participants per group.
2; Adolescents who are 13 to 20 years of age who have ever heard of over-the-counter medication.	Behavioral: Personal Interviews; Conducted by phone and audiotaped.
3; Adults (21 years of age or older) who have used over-the-counter medication in the past 2 years.	Behavioral: Focus Groups; 6 to 8 participants per group.
4; Primary care physicians will be Family Practitioners or General Internist, with an active Texas license, who devote at least 50% of their time to clinical practice.	Behavioral: Focus Groups; 6 to 8 participants per group.
5; Pharmacists holding a PharmD degree and licensure in the state of Texas and work at least half-time in a community pharmacy setting.	Behavioral: Focus Groups; 6 to 8 participants per group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen	1 Year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Maria Suarez-Almazor, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2008
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: January 15, 2009
• First Posted (Estimate): January 16, 2009

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; Acetaminophen; Liver; Qualitative study; Primary care physicians; Pharmacists; OTC; Self-administration; Centers for Education and Research on Therapeutics; CERTS; Over-the-counter Acetaminophen; Parental administration; Houston; Texas; Liver toxicity; Family Practitioners; General Internist
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Liver Diseases; Liver Failure
• Other Study ID Numbers: 2008-0577; 1U18HS017991-01 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No