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Completed

NCT Number: NCT04380246

COA-APTIC Clinician Concept Elicitation Study

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.

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Key information

Conditions

Pain Measurement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Physician
  • Clinical pharmacist (PharmD)
  • Nurse practitioner
  • Physician assistant
  • 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

  • Lack of access to a telephone for interview

Treatment and study plan

Qualitative interview

Other

There is no intervention as part of this study. Clinicians will participate in a qualitative interview.

Primary outcomes

  1. Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age

    Time frame: 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

  2. Clinician perspectives on how and when to treat acute pain in children 0 to <3 years of age

    Time frame: 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

  3. Clinician perspectives on how to evaluate response to treatment for acute pain in children 0 to <3 years of age

    Time frame: 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

  4. Clinician perspectives on important side effects of acute pain therapeutics in children 0 to <3 years of age

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 8, 2020
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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