Understanding Patient's Knowledge and Use of Acetaminophen
2 other identifiers
observational
124
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2008
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2008
CompletedFirst Submitted
Initial submission to the registry
January 15, 2009
CompletedFirst Posted
Study publicly available on registry
January 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 27, 2020
January 1, 2020
12 years
January 15, 2009
January 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen
1 Year
Study Arms (5)
1
Parents of children under 8 years of age who have ever given their children an over- the-counter medication.
2
Adolescents who are 13 to 20 years of age who have ever heard of over-the-counter medication.
3
Adults (21 years of age or older) who have used over-the-counter medication in the past 2 years.
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.
5
Pharmacists holding a PharmD degree and licensure in the state of Texas and work at least half-time in a community pharmacy setting.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Children's Hospital of Philadelphia, University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Harris County Hospital District Outpatient Clinics
Houston, Texas, 77030, United States
Kelsey Seybold
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Suarez-Almazor, MD, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2009
First Posted
January 16, 2009
Study Start
December 19, 2008
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
January 27, 2020
Record last verified: 2020-01