Understanding Patient's Knowledge and Use of Acetaminophen
13 Years
N/A
Both
Liver Failure
Trial Information
Understanding Patient's Knowledge and Use of Acetaminophen
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen
Outcome Time Frame:
1 Year
Safety Issue:
No
Principal Investigator
Maria Suarez-Almazor, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2008-0577
NCT ID:
NCT00823758
Start Date:
December 2008
Completion Date:
Related Keywords:
- Liver Failure
- Acetaminophen
- Liver
- Centers for Education and Research on Therapeutics
- CERTS
- Over-the-counter Acetaminophen
- OTC
- Self-administration
- Parental administration
- Houston
- Texas
- Liver toxicity
- Qualitative study
- Pharmacists
- Adolescents
- Primary care physicians
- Family Practitioners
- General Internist
- Liver Failure
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| The Children's Hospital of Philadelphia, University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Harris County Hospital District Outpatient Clinics | Houston, Texas 77030 |
| Kelsey Seybold | Houston, Texas 77030 |
