Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT00823758
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Understanding Patient's Knowledge and Use of Acetaminophen
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Understanding Patient's Knowledge and Use of Acetaminophen
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U18HS017991-01 | AHRQ | None | https://reporter.nih.gov/quic… | View |