Increasing Infant Preventive Health Service Delivery in an Inner City Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00221507
First received: September 16, 2005
Last updated: July 17, 2007
Last verified: January 2007
  Purpose

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 Intervention
Healthy
Behavioral: Reminder-Recall-Outreach
Behavioral: Case Management
Behavioral: Patient Navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Increasing Infant Preventive Health Service Delivery in an Inner City Population

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Infant immunization status
  • Infant well child care status

Secondary Outcome Measures:
  • Health care utilization
  • Enrollment in health insurance program
  • Screening rates for anemia and lead toxicity

Estimated Enrollment: 800
Study Start Date: February 2004
Estimated Study Completion Date: June 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221507

Contacts
Contact: Stephanie Phibbs, MPH 303-724-1080 stephanie.phibbs@uchsc.edu

Locations
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Stephanie Phibbs, MPH    303-724-1080    stephanie.phhibbs@uchsc.edu   
Principal Investigator: Simon Hambidge         
Sponsors and Collaborators
University of Colorado, Denver
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Simon Hambidge, MD, PhD UCDHSC
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00221507     History of Changes
Other Study ID Numbers: RWJ 048472
Study First Received: September 16, 2005
Last Updated: July 17, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014