Understanding Patient's Knowledge and Use of Acetaminophen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00823758
First received: January 15, 2009
Last updated: July 9, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2015 (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
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823758

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Harris County Hospital District Outpatient Clinics
Houston, Texas, United States, 77030
Kelsey Seybold
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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, 1U18HS017991-01
Study First Received: January 15, 2009
Last Updated: July 9, 2014
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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 16, 2014