NCT00221507

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
823

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

6.2 years

First QC Date

September 16, 2005

Last Update Submit

April 15, 2019

Conditions

Healthy

Keywords

VaccinationPrevention & Control

Outcome Measures

Primary Outcomes (2)

  • Change in Infant immunization status

  • Change in Infant well child care status

Secondary Outcomes (3)

  • Change in Health care utilization

  • Change in Enrollment in health insurance programs

  • Change in Screening rates for anemia and lead toxicity

Study Arms (4)

Historical Cohort

NO INTERVENTION

This study will first examine risk factors in a defined population of inner city children, using a historical cohort.

Reminder Recall Outreach

ACTIVE COMPARATOR

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.

Behavioral: Reminder-Recall-Outreach

Case Management

ACTIVE COMPARATOR

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.

Behavioral: Case Management

Patient Navigation

ACTIVE COMPARATOR

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.

Behavioral: Patient Navigator

Interventions

Reminder-Recall-OutreachBEHAVIORAL
Reminder Recall Outreach
Case ManagementBEHAVIORAL
Case Management
Patient NavigatorBEHAVIORAL
Patient Navigation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No medical care in the Denver Health community health system after 42 days of age.
  • Birthweight less than 1500 grams.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

  • Hambidge SJ, Phibbs SL, Chandramouli V, Fairclough D, Steiner JF. A stepped intervention increases well-child care and immunization rates in a disadvantaged population. Pediatrics. 2009 Aug;124(2):455-64. doi: 10.1542/peds.2008-0446. Epub 2009 Jul 27.

    PMID: 19651574DERIVED

MeSH Terms

Interventions

Case ManagementPatient Navigation

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services AdministrationPatient-Centered CarePrimary Health Care

Study Officials

  • Simon Hambidge, MD, PhD

    UCDHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

February 1, 2004

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

US(1)