Clinical trial NCT06164028: COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Official title: A Qualitative Cognitive Interview Study to Evaluate Comprehensibility and Content Validity of a Caregiver Observer-reported Assessment and a Clinician-reported Assessment of Acute Pain in Infants and Young Children Who Are 0 to <2 Years of Age.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2023-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers who cares for a child who is between 0 and 2 years and experiencing or has experienced acute pain.

Clinicians who treats or works with pediatric patients who are between 0 and 2 years and being treated for acute pain.

Brief summary: Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).

Detailed description: The study aims to assess understandability (clarity) and content validity of the newly designed clinician-reported outcome (ClinRO) and the existing clinician-reported outcome (ClinRO) measures of acute pain in infants and young children who are 0 to \<2 years of age.

This qualitative research employs 60-minute cognitive interviews conducted through phone or zoom by a trained interviewer. The study involves caregivers with children aged 0 to \<2 years old who are experiencing or have experienced acute pain, and clinicians who dedicate at least half of their clinical time caring for pediatric patients within the same age range.

The data analysis will be of a qualitative nature and rely on in-depth interviews conducted with relatively limited sample sizes.

The study entails utilizing standard interview techniques and poses a negligible amount of risk. However, there is the potential risk of loss of confidentiality.

Eligibility criteria: Inclusion Criteria:

Caregivers

* Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions
* Is over the age of 18 years
* Can speak and understand English or Spanish
* Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record.

Clinicians

* Practicing clinician in a clinical care environment
* Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain.
* Cares for pediatric patients \>50% of their clinical time.
* Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher)
* Is over the age of 18 years
* Can speak and understand English
* Is capable of and willing to provide informed consent for interview participation.

Exclusion Criteria:

* Lack of access to a telephone or computer for interview
* For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.

Primary outcomes:
measure: Number of participants who understand features of the clinical outcome assessments
timeFrame: Approximately 1 hour
measure: Number of participants who find the indicators included in the clinical outcome assessments complete and relevant
timeFrame: Approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Kanecia Zimmerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: