COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Trial Parameters
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).
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 unde