Clinical trial NCT04380246: COA-APTIC Clinician Concept Elicitation 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Measurement
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2020-05-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age
timeFrame: 1 hour
measure: Clinician perspectives on how and when to treat acute pain in children 0 to <3 years of age
timeFrame: 1 hour
measure: Clinician perspectives on how to evaluate response to treatment for acute pain in children 0 to <3 years of age
timeFrame: 1 hour
measure: Clinician perspectives on important side effects of acute pain therapeutics in children 0 to <3 years of age
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Bryce Reeve, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Kanecia Zimmerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: