COA-APTIC Clinician Concept Elicitation Study

Pain Measurement Clinical Trial

Official title:

COA-APTIC CLINICIAN 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: NCT04380246
• Other study ID #: Pro00105109
• Status: Completed
• Start date: August 6, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: April 2020
• 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 acute pain assessment, treatment, and response to treatment in infants and young children, age 0 to 3 years old, from a clinician's perspective.

Description:

The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials of acute pain therapeutics in children who are 0 to <3 years of age from a clinician's perspective. To identify these endpoints and outcomes the investigators will conduct remote qualitative concept elicitation interviews with 27 clinicians who treat pediatric patients. These interviews will include verbal consent to participate, a demographics questionnaire, and a semi-structured interview which will last approximately one hour. Interview questions will address the participant's professional experience recognizing and managing pain in children between 0 and 3 years of age. Interviews will be audio recorded and transcribed with the participant's permission. Transcripts and notes will be coded and analyzed. This is a minimal risk study; the investigators are only using standard interview procedures and are not collecting any protected health information from participants. While the investigators do not believe that any information collected would jeopardize the personal or professional standing of participants, all information will be kept strictly confidential per Good Clinical Practice guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is a practicing clinician in a clinical care environment

2. Cares for pediatric patients >50% of their time

3. Treats or works with pediatric patients who are between 0 and <3 years of age AND being treated for acute pain

4. Holds one of the following titles/positions

1. Physician

2. Clinical pharmacist (PharmD)

3. Nurse practitioner

4. Physician assistant

5. Nurse (with a BSN/RN or higher)

5. Is over the age of 18 years

6. Can speak and understand English

7. Is capable of giving informed verbal consent

Exclusion Criteria:

1. Lack of access to a telephone for interview

Related Conditions & MeSH terms

• Pain Measurement

Intervention

Other:
• Qualitative Interview
There is no intervention as part of this study. Clinicians will participate in a qualitative interview.

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	Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age	A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians identify and recognize acute pain in infants and young children	1 hour
Primary	Clinician perspectives on how and when to treat acute pain in children 0 to <3 years of age	A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians treat acute pain in infants and young children	1 hour
Primary	Clinician perspectives on how to evaluate response to treatment for acute pain in children 0 to <3 years of age	A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess how clinicians evaluate response to treatment for acute pain in infants and young children	1 hour
Primary	Clinician perspectives on important side effects of acute pain therapeutics in children 0 to <3 years of age	A 1-hour qualitative interview will be conducted and transcript or interviewer notes coded to assess important side effects of acute pain therapeutics in infants and young children	1 hour