Increasing Infant Preventive Health Service Delivery in an Inner City Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221507
Recruitment Status : Unknown
Verified January 2007 by University of Colorado, Denver.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : July 18, 2007
Robert Wood Johnson Foundation
Information provided by:
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Reminder-Recall-Outreach Behavioral: Case Management Behavioral: Patient Navigator Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Infant Preventive Health Service Delivery in an Inner City Population
Study Start Date : February 2004
Study Completion Date : June 2007

Primary Outcome Measures :
  1. Infant immunization status
  2. Infant well child care status

Secondary Outcome Measures :
  1. Health care utilization
  2. Enrollment in health insurance program
  3. Screening rates for anemia and lead toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221507

Contact: Stephanie Phibbs, MPH 303-724-1080

United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Stephanie Phibbs, MPH    303-724-1080   
Principal Investigator: Simon Hambidge         
Sponsors and Collaborators
University of Colorado, Denver
Robert Wood Johnson Foundation
Principal Investigator: Simon Hambidge, MD, PhD UCDHSC

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00221507     History of Changes
Other Study ID Numbers: RWJ 048472
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 18, 2007
Last Verified: January 2007

Keywords provided by University of Colorado, Denver:
Prevention & Control