MDACC Study Summary 2008-0577

Study Summary
No. 2008-0577:.......Liver......Maria Suarez-Almazor......General Internal Medicine/Ambulatory Treatment & Emergency Care

Study Summary Title



Study Summary Number:	2008-0577

Study Title:	Understanding Patient's Knowledge and Use of Acetaminophen

Physician

New Patient Referral



Name:	Maria Suarez-Almazor	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	General Internal Medicine/Ambulatory Treatment & Emergency Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4516 Contact us about clinical trials

General Information



Disease Group:	Liver	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Not applicable

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Only outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	The goal of this health services research study is to learn more about the ways people take acetaminophen. Researchers also want to learn more about the knowledge, attitudes, and beliefs of people who take acetaminophen.

Study Objectives / Outcomes

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 submitted 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 study objectives are listed below:

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.

Project II-(Phase 1)- 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 Status Information



Study Activation / Registration Date:	12/19/2008

IRB Review and Approval Date:	12/19/2008

Study Type:	Observational

Recruitment Status:	Open

Projected Accrual:	124 total patients. Approximately 20 patients will be recruited per month.

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00823758
Study Information on Clinical Trials Registry (clinicaltrials.gov)