COA-APTIC Clinician Concept Elicitation Study

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04380246
• Collaborator: Food and Drug Administration (FDA) (U.S. Fed)
• Enrollment: 27
• Location: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Measurement	Other: Qualitative Interview

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 27 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: Aug 6, 2020
• Actual Primary Completion Date: Dec 21, 2020
• Actual Study Completion Date: Dec 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; There is no intervention as part of this study. Clinicians will participate in a qualitative interview.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

5. Physician

6. Clinical pharmacist (PharmD)

7. Nurse practitioner

8. Physician assistant

9. Nurse (with a BSN/RN or higher)

10. Is over the age of 18 years

11. Can speak and understand English

12. Is capable of giving informed verbal consent

Exclusion Criteria:

1. Lack of access to a telephone for interview

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27701

Sponsors and Collaborators

• Duke University
• Food and Drug Administration (FDA)

Investigators

• Principal Investigator: Bryce Reeve, PhD, Duke University
• Principal Investigator: Kanecia Zimmerman, MD, MPH, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04380246
• Other Study ID Numbers: Pro00105109
• First Posted: May 8, 2020
• Last Update Posted: Mar 9, 2021
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 9, 2021