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

Acute Pain Clinical Trial

— COA-APTIC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164028
• Other study ID #: Pro00112874
• Status: Recruiting
• Start date: August 15, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Sophie Wang, MBBS, MHS
• Phone: 919-668-5971
• Email: sophie.wang[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

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

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who understand features of the clinical outcome assessments	Understanding (or clarity) of all features of the clinical outcome assessments (ObsRO measure or ClinRO measures) including, but not limited to, its instructions, questions, and response options.	Approximately 1 hour
Primary	Number of participants who find the indicators included in the clinical outcome assessments complete and relevant	Completeness and relevance of indicators included in the clinical outcome assessments (ObsRO measure or ClinRO measures) for capturing observable behaviors in young children when she/he is reacting to painful experiences.	Approximately 1 hour