- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00221507
Increasing Infant Preventive Health Service Delivery in an Inner City Population
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The overall aim of the proposed project is to increase receipt of a broad array of childhood preventive health services in a population of disadvantaged inner city children. Specific hypotheses concerning risk factors for infant under-immunization and lack of receipt of well child care will be tested. This study will first examine these risk factors in a defined population of inner city children, using a historical cohort. Finally, through the use of a randomized controlled trial in a prospective birth cohort, it will test an intervention, based partly on the evidence gathered from the initial study phases, to increase immunization rates and well child care delivery in those children most at risk for "falling through the cracks." These studies will be conducted in the Denver Health community health network, the largest integrated community health care system in the United States.
Information gathered via rigorous exploration of risk factors for inadequate preventive service receipt in inner city children is especially important at present, because despite rising immunization rates around the country, it is clear that "pockets of need" remain in many urban locations. Children in these pockets of need, in addition to being under-immunized, also are at higher risk for lack of other preventive services, and suffer from higher rates of iron deficiency anemia and lead poisoning. The knowledge gained from both the descriptive and interventional parts of the study will provide crucial information for physicians who care for these children, health care systems that serve them, and policy makers responsible for promoting effective tools and funding their implementation. The information gained herein will also provide important methodological insight for generalists who wish to conduct interventional studies in large urban populations, by further refining existing methods used in design and implementation of large cohort studies in disadvantaged children.
Although this project will be conducted among a population of disadvantaged inner city children, many of the findings from these studies will likely be applicable in health care systems that serve other socioeconomic groups. All primary care physicians who care for children face the challenge of trying to boost childhood immunization rates over 90%, and to increase the delivery of a full spectrum of preventive health services to children. The investigators hope that the evidence from this project will inform and shape both the clinical practice of individual health care providers and health care systems charged with providing preventive health care to children in a wide variety of settings.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Colorado
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Denver, Colorado, Stati Uniti, 80204
- Denver Health Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Any child born at Denver Health Medical Center between 2/1/04 and 1/31/05 who receives primary care at one of 3 community health centers.
Exclusion Criteria:
- No medical care in the Denver Health community health system after 42 days of age.
- Birthweight less than 1500 grams.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Historical Cohort
This study will first examine risk factors in a defined population of inner city children, using a historical cohort.
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Comparatore attivo: Reminder Recall Outreach
To determine how well Reminder Recall Outreach will increase immunization rates and well child care delivery in those children most at risk for "falling through the cracks."
These studies will be conducted in the Denver Health community health network, the largest integrated community health care system in the United States.
|
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Comparatore attivo: Case Management
To determine how well Case Management will increase immunization rates and well child care delivery in those children most at risk for "falling through the cracks."
These studies will be conducted in the Denver Health community health network, the largest integrated community health care system in the United States.
|
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Comparatore attivo: Patient Navigation
To determine how well Patient Navigation will increase immunization rates and well child care delivery in those children most at risk for "falling through the cracks."
These studies will be conducted in the Denver Health community health network, the largest integrated community health care system in the United States.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Change in Infant immunization status
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Change in Infant well child care status
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Misure di risultato secondarie
Misura del risultato |
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Change in Health care utilization
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Change in Enrollment in health insurance programs
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Change in Screening rates for anemia and lead toxicity
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Simon Hambidge, MD, PhD, UCDHSC
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 03-1082
- RWJ 048472 (Altro numero di sovvenzione/finanziamento: Robert Wood Johnson Foundation)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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