COA-APTIC Clinician Concept Elicitation Study

NCT04380246 | Completed

• 1 other identifier: Pro00105109
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Measurement

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Clinicians

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.

Other: Qualitative Interview

Interventions

Qualitative Interview OTHER

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

Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be practicing clinicians who care for pediatric patients \> 50% of their time, and who treat pediatric patients who are in acute pain and between 0 and 3 years of age

You may qualify if:

• 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

You may not qualify if:

• \. Lack of access to a telephone for interview

Sponsors & Collaborators

• Duke University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27701, United States

Location

Study Officials

• Bryce Reeve, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Kanecia Zimmerman, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: August 6, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: March 9, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)