Studio di intervista cognitiva COA-APTIC sulla valutazione del dolore acuto nei neonati e nei bambini piccoli da parte di operatori sanitari e medici (COA-APTIC)
Uno studio di intervista cognitiva qualitativa per valutare la comprensibilità e la validità del contenuto di una valutazione riferita dall'osservatore del caregiver e di una valutazione riferita dal medico del dolore acuto nei neonati e nei bambini piccoli da 0 a
Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to <2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - <2 years).
Panoramica dello studio
Descrizione dettagliata
The study aims to assess understandability (clarity) and content validity of the newly designed clinician-reported outcome (ClinRO) and the existing clinician-reported outcome (ClinRO) measures of acute pain in infants and young children who are 0 to <2 years of age.
This qualitative research employs 60-minute cognitive interviews conducted through phone or zoom by a trained interviewer. The study involves caregivers with children aged 0 to <2 years old who are experiencing or have experienced acute pain, and clinicians who dedicate at least half of their clinical time caring for pediatric patients within the same age range.
The data analysis will be of a qualitative nature and rely on in-depth interviews conducted with relatively limited sample sizes.
The study entails utilizing standard interview techniques and poses a negligible amount of risk. However, there is the potential risk of loss of confidentiality.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27701
- Duke Clinical Research Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Caregivers who cares for a child who is between 0 and 2 years and experiencing or has experienced acute pain.
Clinicians who treats or works with pediatric patients who are between 0 and 2 years and being treated for acute pain.
Descrizione
Inclusion Criteria:
Caregivers
- Cares for a child who is both: Between 0 and <2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions
- Is over the age of 18 years
- Can speak and understand English or Spanish
- Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record.
Clinicians
- Practicing clinician in a clinical care environment
- Treats or works with pediatric patients who are between 0 and <2 years of age AND being treated for acute pain.
- Cares for pediatric patients >50% of their clinical time.
- Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher)
- Is over the age of 18 years
- Can speak and understand English
- Is capable of and willing to provide informed consent for interview participation.
Exclusion Criteria:
- Lack of access to a telephone or computer for interview
- For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: OTHER
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Caregiver
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. |
Participants will take part in a semi-structured qualitative interview (~1 hour). |
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Clinician
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. |
Participants will take part in a semi-structured qualitative interview (~1 hour). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants who understand features of the clinical outcome assessments
Lasso di tempo: Approximately 1 hour
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Understanding (or clarity) of all features of the clinical outcome assessments (ObsRO measure or ClinRO measures) including, but not limited to, its instructions, questions, and response options. |
Approximately 1 hour
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Number of participants who find the indicators included in the clinical outcome assessments complete and relevant
Lasso di tempo: Approximately 1 hour
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Completeness and relevance of indicators included in the clinical outcome assessments (ObsRO measure or ClinRO measures) for capturing observable behaviors in young children when she/he is reacting to painful experiences. |
Approximately 1 hour
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kanecia Zimmerman, MD, MPH, Duke University
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00112874
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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