Status:
RECRUITING
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Lead Sponsor:
Duke University
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Acute Pain
Eligibility:
All Genders
18+ years
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 o...
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 acu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06164028
Start Date
August 15 2023
End Date
August 31 2026
Last Update
September 9 2025
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701