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临床试验/NCT04380246
NCT04380246已完成不适用

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

Duke University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Clinician perspectives on how to identify or recognize pain in children 0 to <3 years of age

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • Lack of access to a telephone for interview

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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COA-APTIC Clinician Concept Elicitation Study | 临床试验