Translating Evidence Based Developmental Screening Into Pediatric Primary Care (TEDS)
8 november 2011 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
2314
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- CHOP - Primary Care Market Street
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- CHOP Primary Care-University City
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Philadelphia, Pennsylvania, Verenigde Staten, 19139
- CHOP Primary Care Center- Cobbs Creek
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Philadelphia, Pennsylvania, Verenigde Staten, 19145
- CHOP Primary Care - South Philadelphia
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 2 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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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.
Tijdsspanne: We assessed this between June to October 2010
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We assessed this between June to October 2010
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Percentage of children in the study who are referred to Early Intervention Services
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: James P Guevara, MD MPH, Children's Hospital of Philadelphia
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2008
Primaire voltooiing (Werkelijk)
1 oktober 2010
Studie voltooiing (Werkelijk)
1 oktober 2010
Studieregistratiedata
Eerst ingediend
13 februari 2009
Eerst ingediend dat voldeed aan de QC-criteria
13 februari 2009
Eerst geplaatst (Schatting)
16 februari 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
10 november 2011
Laatste update ingediend die voldeed aan QC-criteria
8 november 2011
Laatst geverifieerd
1 november 2011
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2008-9-6124
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