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HealthyNCT00221507

Increasing Infant Preventive Health Service Delivery in an Inner City Population

A study testing Reminder-Recall-Outreach, Case Management and Patient Navigator in people with Healthy, run by University of Colorado, Denver at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Reminder-Recall-Outreach, Case Management and Patient Navigator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
823 participants
Where
1 siteUnited States
Study dates
Feb 2004to Apr 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Denver Health Medical Center

    Denver, Colorado, 80204

Other trials in United States

About this study

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.

Read the 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.

Conditions
Healthy
Being tested
Reminder-Recall-Outreach, Case Management, Patient Navigator
Keywords
Vaccination, Prevention & Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reminder-Recall-OutreachBehavioural

  • Case ManagementBehavioural

  • Patient NavigatorBehavioural

Study groups in NCT00221507
Study groupRoleWhat they receive
Historical CohortNo interventionThis study will first examine risk factors in a defined population of inner city children, using a historical cohort.
Reminder Recall OutreachActive comparatorTo 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.
Receives: Behavioral: Reminder-Recall-Outreach
Case ManagementActive comparatorTo 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.
Receives: Behavioral: Case Management
Patient NavigationActive comparatorTo 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.
Receives: Behavioral: Patient Navigator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Infant immunization status

  2. Change in Infant well child care status

Secondary outcomes (3)
  1. Change in Health care utilization

  2. Change in Enrollment in health insurance programs

  3. Change in Screening rates for anemia and lead toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2004
  3. Primary completionApr 2010
  4. Study completionApr 2010

Why it stopped: Expiration of IRB Approval

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221507
Sponsor's protocol ID
03-1082
Other IDs
RWJ 048472
Status last verified
Apr 2019
First submitted
16 Sep 2005
Last updated
17 Apr 2019
Results posted
No

Publications

  • 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.

    PubMed 19651574

Questions about this trial

What is this clinical trial studying?

A study testing Reminder-Recall-Outreach, Case Management and Patient Navigator in people with Healthy, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Expiration of IRB Approval). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Infant immunization status. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00221507, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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