COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children

Официальное название

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.

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое cognitive interview
  Participants will take part in a semi-structured qualitative interview (\~1 hour).

Первичные конечные точки

• Number of participants who understand features of the clinical outcome assessments [Срок оценки: Approximately 1 hour]
• Number of participants who find the indicators included in the clinical outcome assessments complete and relevant [Срок оценки: Approximately 1 hour]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Duke Clinical Research Institute — Durham

Идентификаторы

NCT: NCT06164028 · Pro00112874

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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