COA-APTIC Clinician Concept Elicitation Study

Completed

Brief 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.

Detailed 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 & Eligibility

Inclusion Criteria

Is a practicing clinician in a clinical care environment
Cares for pediatric patients >50% of their time
Treats or works with pediatric patients who are between 0 and <3 years of age AND being treated for acute pain
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)
Is over the age of 18 years
Can speak and understand English
Is capable of giving informed verbal consent

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Clinicians	Qualitative Interview	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.

Primary Outcome Measures

Name	Time	Method
Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age	1 hour	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
Clinician perspectives on important side effects of acute pain therapeutics in children 0 to <3 years of age	1 hour	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
Clinician perspectives on how and when to treat acute pain in children 0 to <3 years of age	1 hour	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
Clinician perspectives on how to evaluate response to treatment for acute pain in children 0 to <3 years of age	1 hour	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

Secondary Outcome Measures

Name	Time	Method

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial