COA-APTIC Kognitiv intervjustudie av omsorgsperson og klinikervurdering av akutte smerter hos spedbarn og små barn (COA-APTIC)
En kvalitativ kognitiv intervjustudie for å evaluere forståelighet og innholdsvaliditet av en omsorgsgiver Observatørrapportert vurdering og en klinikerrapportert vurdering av akutte smerter hos spedbarn og små barn som er 0 til
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).
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27701
- Duke Clinical Research Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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). |
|
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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants who understand features of the clinical outcome assessments
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kanecia Zimmerman, MD, MPH, Duke University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00112874
Plan for individuelle deltakerdata (IPD)
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