Translating Evidence Based Developmental Screening Into Pediatric Primary Care (TEDS)
8 de noviembre de 2011 actualizado por: Children's Hospital of Philadelphia
Translating Evidence Based Developmental Screening Into Pediatric Primary Care ( Aims 2 and 3 )
The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the AAP's recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.
The study will also examine its acceptance by pediatric practices, its adoption and adaptation in urban pediatric practices, and the effectiveness of a developmental screening protocol that conforms to the AAP and Maternal and Child Health Bureau (MCHB) recommendations compared with that of developmental surveillance alone.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
2314
Fase
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- CHOP - Primary Care Market Street
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- CHOP Primary Care-University City
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Philadelphia, Pennsylvania, Estados Unidos, 19139
- CHOP Primary Care Center- Cobbs Creek
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Philadelphia, Pennsylvania, Estados Unidos, 19145
- CHOP Primary Care - South Philadelphia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 2 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age birth to 30 months of age by the start of the intervention phase.
- Child's Primary Care Physician has consented to participate in the study
- Parental/guardian permission (informed consent).
Exclusion Criteria:
- Premature Infants (less than 36 weeks of gestation)
- Children with prior identified developmental delay.
- Children with major congenital anomalies/genetic disorders
- Children placed in foster care
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
3
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: SRS
School Readiness Specialist (SRS) will administer the screening questionnaire to the subject during the intervention period, at the subject's 9, 18, 24 and 30 month visits.
They will then see their PCP for a well child visit in which the results of the test will be interpreted, developmental counseling and/or anticipatory guidance provided as per usual care.
EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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In the SRS intervention arm subjects will complete developmental screening tools with a school readiness specialist at their 9, 18, 24 and 30 month well child visits and then complete their well child visit with their primary care clinician to discuss the results.
Subjects who are randomized to PCP arm will be screened for developmental delays by their Primary Care Clinician at their 9, 18, 24 and 30 month well child visits.
The corresponding screening tools may be mailed to the study participants 2 weeks before the scheduled well child visits.
Those who do not complete the screening tools or those who did not receive them in the mail will then complete the questionnaire in the office prior to seeing their doctor or with their doctor.
The PCP will then score the screening tool and interpret the test results.
Developmental counseling and/or anticipatory guidance will be provided, as per usual care.
EI referral will be completed, at the discretion of the provider with the approval of the caregiver , if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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Experimental: Provider
Primary Care Physician (PCP) will do the developmental screening at the subject's 9, 18, 24 and 30 month well child visits.
Once the screening questionnaire is complete the PCP will then score the screening tool and interpret the test results.
Developmental counseling and/or anticipatory guidance will be provided, as per usual care.
EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
|
In the SRS intervention arm subjects will complete developmental screening tools with a school readiness specialist at their 9, 18, 24 and 30 month well child visits and then complete their well child visit with their primary care clinician to discuss the results.
Subjects who are randomized to PCP arm will be screened for developmental delays by their Primary Care Clinician at their 9, 18, 24 and 30 month well child visits.
The corresponding screening tools may be mailed to the study participants 2 weeks before the scheduled well child visits.
Those who do not complete the screening tools or those who did not receive them in the mail will then complete the questionnaire in the office prior to seeing their doctor or with their doctor.
The PCP will then score the screening tool and interpret the test results.
Developmental counseling and/or anticipatory guidance will be provided, as per usual care.
EI referral will be completed, at the discretion of the provider with the approval of the caregiver , if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
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Sin intervención: Routine
Subjects randomized to routine surveillance will receive routine preventive care as well as developmental surveillance at all well child visits, including the 9, 18, 24 and 30 month visits.
EI referral will be completed, at the discretion of the provider, if the PCP observes a developmental delay during surveillance or the caregivers raise a specific concern about the child's development.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The primary outcome measure for this study will be the percentage of children enrolled in the study who are identified as having a developmental delay.
Periodo de tiempo: We assessed this between June to October 2010
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We assessed this between June to October 2010
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Percentage of children in the study who are referred to Early Intervention Services
Periodo de tiempo: We assessed this in June 2010
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We assessed this in June 2010
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Percentage of children in the study who enroll in Early Intervention Services
Periodo de tiempo: We will assess this between June to October 2010
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We will assess this between June to October 2010
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Percent of parents enrolled in the study who report as satisfied with the intervention
Periodo de tiempo: We assessed this between March and September 2010
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We assessed this between March and September 2010
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Percent of providers enrolled in the study who report as satisfied with the intervention.
Periodo de tiempo: We will assess this between March and September 2010
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We will assess this between March and September 2010
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: James P Guevara, MD MPH, Children's Hospital of Philadelphia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
1 de noviembre de 2008
Finalización primaria (Actual)
Finalización primaria
1 de octubre de 2010
Finalización del estudio (Actual)
Finalización del estudio
1 de octubre de 2010
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
13 de febrero de 2009
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
13 de febrero de 2009
Publicado por primera vez (Estimar)
Publicado por primera vez
16 de febrero de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
10 de noviembre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
8 de noviembre de 2011
Última verificación
Última verificación
1 de noviembre de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2008-9-6124
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