Translating Evidence Based Developmental Screening Into Pediatric Primary Care (TEDS)
8. November 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
2314
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- CHOP - Primary Care Market Street
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- CHOP Primary Care-University City
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19139
- CHOP Primary Care Center- Cobbs Creek
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19145
- CHOP Primary Care - South Philadelphia
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
Nicht älter als 2 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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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.
Zeitfenster: We assessed this between June to October 2010
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We assessed this between June to October 2010
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Percentage of children in the study who are referred to Early Intervention Services
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: James P Guevara, MD MPH, Children's Hospital of Philadelphia
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2008
Primärer Abschluss (Tatsächlich)
1. Oktober 2010
Studienabschluss (Tatsächlich)
1. Oktober 2010
Studienanmeldedaten
Zuerst eingereicht
13. Februar 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Februar 2009
Zuerst gepostet (Schätzen)
16. Februar 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
10. November 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. November 2011
Zuletzt verifiziert
1. November 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2008-9-6124
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