Understanding Patient's Knowledge and Use of Acetaminophen
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Failure |
Behavioral: Focus Groups Behavioral: Personal Interviews |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Understanding Patient's Knowledge and Use of Acetaminophen |
- Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- English or Spanish language proficiency.
- Residence in Metropolitan Houston, Texas.
- Adequate cognition as determined by the research staff through the use of questions related to orientation about person, time and place.
- 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.
- 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.
- 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:
- Participants who do not give informed consent.
- A parent whose spouse/partner is/has already participated in the focus group.
- Pharmacists actively enrolled in a training program.
- Physicians who are participating in a fellowship or residency training program.
- Children who may be depressed or at risk of suicide or managing that risk.
Contacts and Locations| Contact: Maria Suarez-Almazor, MD, PhD | 713-745-4516 |
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia, University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Harris County Hospital District Outpatient Clinics | Recruiting |
| Houston, Texas, United States, 77030 | |
| Kelsey Seybold | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Maria Suarez-Almazor, MD, PhD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00823758 History of Changes |
| Other Study ID Numbers: | 2008-0577 |
| Study First Received: | January 15, 2009 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Acetaminophen Antipyretics Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013