COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
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.
Duke University
60 participants
Aug 15, 2023
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria13
- 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 Criteria2
- 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.
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Interventions
Participants will take part in a semi-structured qualitative interview (\~1 hour).
Locations(1)
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NCT06164028