COA-APTIC Caregiver Concept Elicitation Study

Pain Measurement Clinical Trial

Official title:

COA-APTIC Caregiver Concept Elicitation Study: A Qualitative Concept Elicitation Study to Identify Important Aspects of Pain Assessment, Treatment, and Response to Treatment in Children Who Are 0 to <3 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392180
• Other study ID #: Pro00105117
• Status: Completed
• Start date: June 23, 2021
• Est. completion date: April 26, 2022

Study information

• Verified date: August 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a concept elicitation study to identify important aspects of pain assessment, treatment, and response to treatment in children under than 3 years of age from a caregiver's perspective.

Description:

The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials for acute pain therapeutics in infants and young children from a caregiver's perception. Study team members will conduct phone-based qualitative interviews, using a semi-structured interview guide, with 42 primary caregivers of pediatric patients under 3 years of age who are experiencing or have experienced acute pain. Once participants give verbal consent, they will fill out a demographics form. Interviews will last about one hour and will address the participant's experience recognizing and managing their child's acute pain. The investigators will use these concept elicitation interviews to identify important aspects of acute pain assessment, treatment, and response to treatment in children who are under 3 years old. Interviews will be audio recorded and transcribed with participant permission. Transcripts or interviewer notes will be reviewed by two analysts and will be double coded until inter-rater reliability is reached by agreement of at least 80%. The study team will conduct a thematic analysis of the coded transcripts. This is a minimal risk study. All information will be kept confidential and information will be stored on a secure network which is only accessible to the study team.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cares for a child who is both:

• Between 0 and <3 years of age
• Experiencing or has experienced acute pain in one of the following categories:
• Malignant or non-malignant visceral or hematologic disease
• Surgery (or other procedure)
• Trauma or injury
• Congenital conditions

2. Is over the age of 18 years old.

3. Can speak and understand English.

4. Is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record.

Exclusion Criteria:

1. Lack of access to a telephone or computer for interview

2. Has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.

Related Conditions & MeSH terms

• Pain Measurement

Intervention

Other:
• Qualitative Interview
There is no intervention as part of this study. Caregivers will participate in a qualitative interview over the phone or by video.

Locations

Country	Name	City	State
United States	Duke University	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	Caregiver perspective on how to identify or recognize pain in children 0 to <3 years old.	A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess how caregivers identify and recognize acute pain in infants and young children.	1 hour
Primary	Caregiver perspective on how and when to intervene for acute pain in children 0 to <3 years old.	A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess caregiver's perspective on how and when to treat acute pain in infants and young children.	1 hour
Primary	Caregiver perspective on how to evaluate response to treatment for acute pain in children 0 to <3 years old.	A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess how caregivers evaluate response to treatment for acute pain in infants and young children.	1 hour
Primary	Caregiver perspective on important side effects of acute pain therapeutics in children 0 to <3 years old.	A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess caregiver's perspective on important side effects of acute pain in infants and young children.	1 hour