Estudo de entrevista cognitiva COA-APTIC sobre avaliação de cuidadores e médicos sobre dor aguda em bebês e crianças pequenas (COA-APTIC)
Um estudo qualitativo de entrevista cognitiva para avaliar a compreensibilidade e a validade do conteúdo de uma avaliação relatada pelo observador do cuidador e uma avaliação da dor aguda relatada pelo médico em bebês e crianças pequenas de 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).
Visão geral do estudo
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27701
- Duke Clinical Research Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants who understand features of the clinical outcome assessments
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kanecia Zimmerman, MD, MPH, Duke University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00112874
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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