Liver FailureNCT00823758
Understanding Patient's Knowledge and Use of Acetaminophen
An observational study of Liver Failure, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Failure
- What is being tested?
- Focus Groups and Personal Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Dec 2008to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baylor College of Medicine
Houston, Texas, 77030
Harris County Hospital District Outpatient Clinics
Houston, Texas, 77030
Kelsey Seybold
Houston, Texas, 77030
The Children's Hospital of Philadelphia, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Liver Failure
- Being tested
- Focus Groups, Personal Interviews
- Keywords
- 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
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupsBehavioural
6 to 8 participants per group.
Personal InterviewsBehavioural
Conducted by phone and audiotaped.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Parents of children under 8 years of age who have ever given their children an over- the-counter medication. Receives: Behavioral: Focus Groups | |
| 2 | Adolescents who are 13 to 20 years of age who have ever heard of over-the-counter medication. Receives: Behavioral: Personal Interviews | |
| 3 | Adults (21 years of age or older) who have used over-the-counter medication in the past 2 years. Receives: Behavioral: Focus Groups | |
| 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. Receives: Behavioral: Focus Groups | |
| 5 | Pharmacists holding a PharmD degree and licensure in the state of Texas and work at least half-time in a community pharmacy setting. Receives: Behavioral: Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study start19 Dec 2008
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Suarez-Almazor, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823758
- Sponsor's protocol ID
- 2008-0577
- Other IDs
- 1U18HS017991-01
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2009
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient's Knowledge and Use of Acetaminophen
- ClinicalTrials.gov ID
- NCT00823758
- Acronym / sponsor ID
- 2008-0577
- Conditions
- Liver Failure
- Keywords
- Acetaminophen, Liver, Centers for Education and Research on Therapeutics, CERTS, Over-the-counter Acetaminophen, OTC, Self-administration, Parental administration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Dec 2008 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Focus GroupsParents of children under 8 years of age who have ever given their children an over- the-counter medication. |
| 2 | – | Behavioral: Personal InterviewsAdolescents who are 13 to 20 years of age who have ever heard of over-the-counter medication. |
| 3 | – | Behavioral: Focus GroupsAdults (21 years of age or older) who have used over-the-counter medication in the past 2 years. |
| 4 | – | Behavioral: Focus GroupsPrimary 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 | – | Behavioral: Focus GroupsPharmacists holding a PharmD degree and licensure in the state of Texas and work at least half-time in a community pharmacy setting. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Groups6 to 8 participants per group. | Behavioural | 1, 3, 4, 5 |
| Personal InterviewsConducted by phone and audiotaped. | Behavioural | 2 |
Primary outcome
Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Suarez-Almazor, MD, PhD principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitatively Described Patterns of Use + Misuse of Over-the-counter (OTC) Acetaminophen (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.