COA-APTIC Clinician Concept Elicitation Study

Duke University

Status: Completed

Conditions: Pain Measurement

Treatments: Other: Qualitative Interview

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04380246

Pro00105109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

27 participants in 1 patient group

Clinicians

Description:

Clinicians who care for pediatric patients \>50% of their time, who treat pediatric patients who are in acute pain and between 0 and 3 years of age. May include physicians, clinical pharmacists, nurse practitioners, physician assistants, and/or nurses. This cohort will complete a qualitative interview about pain and distress in infants and young children.

Treatment:

Other: Qualitative Interview