Increasing Infant Preventive Health Service Delivery in an Inner City Population

Healthy Clinical Trial

Official title:

Increasing Infant Preventive Health Service Delivery in an Inner City Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00221507
• Other study ID #: 03-1082
• Secondary ID: RWJ 048472
• Status: Terminated
• Phase: N/A
• Start date: February 2004
• Est. completion date: April 2010

Study information

• Verified date: April 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that case management using patient navigators ("promatoras" in the Latino community) will increase infant immunization rates and use of well child care in an inner city population of low socioeconomic status.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 823
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Reminder-Recall-Outreach

• Case Management

• Patient Navigator

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Infant immunization status
Primary	Change in Infant well child care status
Secondary	Change in Health care utilization
Secondary	Change in Enrollment in health insurance programs
Secondary	Change in Screening rates for anemia and lead toxicity