Pain MeasurementNCT04380246
COA-APTIC Clinician Concept Elicitation Study
An observational study of Pain Measurement, run by Duke University at 1 site in United States.
Trial summary
This is a concept elicitation study to identify important aspects of acute pain assessment, treatment, and response to treatment in infants and young children, age 0 to 3 years old, from a clinician's perspective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Qualitative Interview
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 21 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be practicing clinicians who care for pediatric patients > 50% of their time, and who treat pediatric patients who are in acute pain and between 0 and 3 years of age
Who may be able to join
- Is a practicing clinician in a clinical care environment
- Cares for pediatric patients >50% of their time
- Treats or works with pediatric patients who are between 0 and <3 years of age AND being treated for acute pain
- Holds one of the following titles/positions
- Physician
- Clinical pharmacist (PharmD)
Show all 12Show fewer
- Nurse practitioner
- Physician assistant
- Nurse (with a BSN/RN or higher)
- Is over the age of 18 years
- Can speak and understand English
- Is capable of giving informed verbal consent
Who cannot join
- 1. Lack of access to a telephone for interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COA-APTIC CLINICIAN CONCEPT ELICITATION STUDY: A Qualitative Concept Elicitation Study to Identify Important Aspects of Pain Assessment, Treatment, and Response to Treatment in Children Who Are 0 to <3 Years of Age
This is a concept elicitation study to identify important aspects of acute pain assessment, treatment, and response to treatment in infants and young children, age 0 to 3 years old, from a clinician's perspective.
Read the detailed description
The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials of acute pain therapeutics in children who are 0 to <3 years of age from a clinician's perspective. To identify these endpoints and outcomes the investigators will conduct remote qualitative concept elicitation interviews with 27 clinicians who treat pediatric patients. These interviews will include verbal consent to participate, a demographics questionnaire, and a semi-structured interview which will last approximately one hour. Interview questions will address the participant's professional experience recognizing and managing pain in children between 0 and 3 years of age. Interviews will be audio recorded and transcribed with the participant's permission. Transcripts and notes will be coded and analyzed. This is a minimal risk study; the investigators are only using standard interview procedures and are not collecting any protected health information from participants. While the investigators do not believe that any information collected would jeopardize the personal or professional standing of participants, all information will be kept strictly confidential per Good Clinical Practice guidelines.
- Conditions
- Pain Measurement
- Being tested
- Qualitative Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewOther
There is no intervention as part of this study. Clinicians will participate in a qualitative interview.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians | Clinicians who care for pediatric patients >50% of their time, who treat pediatric patients who are in acute pain and between 0 and 3 years of age. May include physicians, clinical pharmacists, nurse practitioners, physician assistants, and/or nurses.
This cohort will complete a qualitative interview about pain and distress in infants and young children. Receives: Other: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians identify and recognize acute pain in infants and young children
Measured: 1 hour
Clinician perspectives on how and when to treat acute pain in children 0 to <3 years of age
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians treat acute pain in infants and young children
Measured: 1 hour
Clinician perspectives on how to evaluate response to treatment for acute pain in children 0 to <3 years of age
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians evaluate response to treatment for acute pain in infants and young children
Measured: 1 hour
Clinician perspectives on important side effects of acute pain therapeutics in children 0 to <3 years of age
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess important side effects of acute pain therapeutics in infants and young children
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start6 Aug 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Bryce Reeve, PhD, Principal investigator, Duke UniversityKanecia Zimmerman, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380246
- Sponsor's protocol ID
- Pro00105109
- Status last verified
- Apr 2020
- First submitted
- 5 May 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COA-APTIC CLINICIAN CONCEPT ELICITATION STUDY: A Qualitative Concept Elicitation Study to Identify Important Aspects of Pain Assessment, Treatment, and Response to Treatment in Children Who Are 0 to <3 Years of Age
- ClinicalTrials.gov ID
- NCT04380246
- Acronym / sponsor ID
- Pro00105109
- Conditions
- Pain Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 8 May 2020 (actual)
- 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.
This is a concept elicitation study to identify important aspects of acute pain assessment, treatment, and response to treatment in infants and young children, age 0 to 3 years old, from a clinician's perspective.
Detailed description
The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials of acute pain therapeutics in children who are 0 to <3 years of age from a clinician's perspective. To identify these endpoints and outcomes the investigators will conduct remote qualitative concept elicitation interviews with 27 clinicians who treat pediatric patients. These interviews will include verbal consent to participate, a demographics questionnaire, and a semi-structured interview which will last approximately one hour. Interview questions will address the participant's professional experience recognizing and managing pain in children between 0 and 3 years of age. Interviews will be audio recorded and transcribed with the participant's permission. Transcripts and notes will be coded and analyzed. This is a minimal risk study; the investigators are only using standard interview procedures and are not collecting any protected health information from participants. While the investigators do not believe that any information collected would jeopardize the personal or professional standing of participants, all information will be kept strictly confidential per Good Clinical Practice guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinicians | – | Other: Qualitative InterviewClinicians who care for pediatric patients >50% of their time, who treat pediatric patients who are in acute pain and between 0 and 3 years of age. May include physicians, clinical pharmacists, nurse practitioners, physician assistants, and/or nurses. This cohort will complete a qualitative interview about pain and distress in infants and young children. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be practicing clinicians who care for pediatric patients > 50% of their time, and who treat pediatric patients who are in acute pain and between 0 and 3 years of age
Key inclusion criteria (12 listed)
- Is a practicing clinician in a clinical care environment
- Cares for pediatric patients >50% of their time
- Treats or works with pediatric patients who are between 0 and <3 years of age AND being treated for acute pain
- Holds one of the following titles/positions
- Is over the age of 18 years
Key exclusion criteria (1 listed)
- 1. Lack of access to a telephone for interview
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 |
|---|---|---|
| Qualitative InterviewThere is no intervention as part of this study. Clinicians will participate in a qualitative interview. | Other | Clinicians |
Primary outcome
Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age
Time frame: 1 hour
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians identify and recognize acute pain in infants and young children
Clinician perspectives on how and when to treat acute pain in children 0 to <3 years of age
Time frame: 1 hour
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians treat acute pain in infants and young children
Clinician perspectives on how to evaluate response to treatment for acute pain in children 0 to <3 years of age
Time frame: 1 hour
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians evaluate response to treatment for acute pain in infants and young children
Clinician perspectives on important side effects of acute pain therapeutics in children 0 to <3 years of age
Time frame: 1 hour
A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess important side effects of acute pain therapeutics in infants and young children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the study team.
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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.
Bryce Reeve, PhD principal investigator
Duke University
Kanecia Zimmerman, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Measurement, run by Duke University at 1 site 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 12 inclusion and 1 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: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age (time frame: 1 hour). The study lists 4 primary outcomes in all. 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 9 Mar 2021.