Pain Measurement
Conditions
Brief 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.
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.
Interventions
OTHERQualitative Interview
There is no intervention as part of this study. Clinicians will participate in a qualitative interview.
Sponsors
Food and Drug Administration (FDA)
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is a practicing clinician in a clinical care environment 2. Cares for pediatric patients \>50% of their time 3. Treats or works with pediatric patients who are between 0 and \<3 years of age AND being treated for acute pain 4. Holds one of the following titles/positions 1. Physician 2. Clinical pharmacist (PharmD) 3. Nurse practitioner 4. Physician assistant 5. Nurse (with a BSN/RN or higher) 5. Is over the age of 18 years 6. Can speak and understand English 7. Is capable of giving informed verbal consent
Exclusion criteria
1\. Lack of access to a telephone for interview
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age | 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 | 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 | 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 | 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 |
Countries
United States
Outcome results
None listed