Cognitive Interview for Acute Pain

(COA-APTIC Trial)

Overseen By Sophie Wang, MBBS, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: No phone or computer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how caregivers and clinicians assess acute pain in infants and young children under two years old. The goal is to develop reliable tools for future pain treatment studies in this age group. Caregivers with children under two who recently experienced pain from surgery or injury may be suitable participants. Clinicians who frequently work with young children in pain in healthcare settings can also participate.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance pain management for young children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for assessing acute pain in young children?

A previous study found cognitive interviewing to be a helpful way to ensure survey questions are easy to understand. Researchers used this method to improve question phrasing by checking if participants understood them correctly. Cognitive interviewing does not involve taking new drugs or undergoing medical procedures; it is a safe and well-tolerated method. Previous research shows no known risks or side effects from participating in cognitive interviews. It mainly involves discussing questions to ensure clarity and coherence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how we assess pain in infants and young children, an area where current methods can be challenging. Unlike typical assessments that may rely on subjective reports or broad indicators, this study involves both caregivers and clinicians to gather detailed insights through structured interviews. By using age-specific video reviews and tailored questionnaires, the trial seeks to enhance the accuracy and content validity of pain evaluation tools, potentially leading to better pain management for young children.

What evidence suggests that this protocol is effective for assessing acute pain in young children?

Studies have shown that cognitive interviews can make questionnaires more suitable for different groups by capturing their experiences and understanding. This method ensures questions are clear and relevant, particularly when assessing pain in individuals with cognitive challenges. In this trial, participants will be divided into two groups: caregivers and clinicians. Research indicates that involving caregivers in pain assessment enhances reliability and accuracy, as they provide detailed observations of children's pain responses. Clinicians will offer professional assessments based on observable indicators. Both caregiver-reported and clinician-reported assessments in this study aim to create a trustworthy tool for understanding acute pain in infants and young children. This approach has proven effective in similar situations, improving communication and understanding between caregivers and healthcare providers. ^{6 7 8 9 10}

Who Is on the Research Team?

Kanecia Zimmerman, MD, MPH

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

You can communicate in English or Spanish.

You spend more than half of your time caring for children as a doctor or nurse.

You work as a doctor, pharmacist, nurse practitioner, physician's assistant, or nurse with a BSN/RN or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Interview

Caregivers and clinicians participate in semi-structured qualitative interviews to evaluate the comprehensibility and content validity of clinical outcome assessments.

1 hour per interview

1 visit (virtual)

Data Analysis

Qualitative data analysis of interviews to assess understandability and content validity of the outcome measures.

4-6 weeks

Follow-up

Participants are monitored for any feedback or additional insights post-interview.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Interview

How Is the Trial Designed?

Group I: Clinician Experimental Treatment 1 Intervention

Participants will take part in a semi-structured qualitative interview (\~1 hour). The first set of questions will provide an opportunity for the clinicians to describe observable indicators that a young child is in pain. 4 YouTube video links based on age groups (birth to 1 month,1 month to 6 months, 6 months to 12 months, and12 months to 24 months), will be reviewed by participants. Clinicians will be asked to rate the child's pain using the ClinRO measures while being probed for question content and understanding. Subsequently, the cognitive interview scripts will be structured to evaluate different components of the ClinRO measures, including the instructions, the question stems, the response options, and other key aspects of the COA. Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.

Group II: Caregiver Experimental Treatment 1 Intervention

Participants will take part in a semi-structured qualitative interview (\~1 hour). The first set of questions will provide an opportunity for the caregiver to describe the type of conditions or injuries their child has experienced and how their child reacted to the potentially painful experiences. Subsequently, the cognitive interview scripts will be structured to evaluate different components of the questionnaire (ObsRO measure), including the instructions, the question stems, the response options, and other key aspects of the COA.Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12274258/

The comprehensibility and feasibility of the modified brief ... Cognitive interviewing approaches were adapted to optimise participation and expression for diverse cognitive and communication abilities.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12181161/

Pain Assessment and Management in Dementia Care This study aims to explore the perspectives of people with dementia, family carers, and healthcare professionals regarding their experiences and needs for pain ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590109521000057

Caregiver-Reported Pain Management Practices for ... The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth, 16 ...

4. researchgate.net researchgate.net/publication/376483796_Establishing_the_Feasibility_and_Acceptability_of_a_Caregiver_Targeted_Intervention_to_Improve_Pain_Assessment_Among_Persons_With_Dementia

Establishing the Feasibility and Acceptability of a Caregiver ... Training family caregivers in observational pain assessment and subsequent communication of the assessment results to a healthcare provider ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06164028?keyword=%22Acute%20Pain%22

COA-APTIC Cognitive Interview Study of Caregiver and ... The study aims to assess understandability (clarity) and content validity of the newly designed clinician-reported outcome (ClinRO) and the existing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7325837/

Caregiver Needs Assessment in Primary Care - PubMed Central To understand current practices, challenges, and opportunities for a systematic assessment of family caregivers' needs and risks in primary care.

7. stacks.cdc.gov stacks.cdc.gov/view/cdc/159010/cdc_159010_DS1.pdf

Cognitive Interview Evaluation of Questions on Caregiving Analysis of cognitive interviewing data follows a systematic process of synthesis and reduction from interview to report (Miller et al., 2014).16 With consent, ...

8. digital.ahrq.gov digital.ahrq.gov/file/39526/download?token=BQ22KOnK

Improving Patient Safety and Clinician Cognitive Support ... Methods: Several different methods were utilized including qualitative analysis of patient safety event reports, interviews with clinicians, and usability ...

9. academic.oup.com academic.oup.com/intqhc/article/37/3/mzaf056/8172520

development and cognitive testing of a multisetting patient ... The inclusion of focus groups and cognitive interviews with a diverse sample further strengthened the tool's applicability across different healthcare settings.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2949678023000211

Cognitive interviewing as a method to inform questionnaire ... Cognitive interviewing is a valuable evaluation method to check comprehension of a measure and was applied to a new measure of user experience of immersive ...