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Increasing Infant Preventive Health Service Delivery in an Inner City Population

2019年4月15日 更新者:University of Colorado, Denver
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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

823

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Denver、Colorado、美国、80204
        • Denver Health Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Historical Cohort
This study will first examine risk factors in a defined population of inner city children, using a historical cohort.
有源比较器:Reminder Recall Outreach
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.
有源比较器:Case Management
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.
有源比较器:Patient Navigation
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.

研究衡量的是什么?

主要结果指标

结果测量
Change in Infant immunization status
Change in Infant well child care status

次要结果测量

结果测量
Change in Health care utilization
Change in Enrollment in health insurance programs
Change in Screening rates for anemia and lead toxicity

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Simon Hambidge, MD, PhD、UCDHSC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年2月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2010年4月1日

研究注册日期

首次提交

2005年9月16日

首先提交符合 QC 标准的

2005年9月16日

首次发布 (估计)

2005年9月22日

研究记录更新

最后更新发布 (实际的)

2019年4月17日

上次提交的符合 QC 标准的更新

2019年4月15日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 03-1082
  • RWJ 048472 (其他赠款/资助编号:Robert Wood Johnson Foundation)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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