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临床试验/NCT00613275
NCT00613275已完成4 期

Patient Navigation in the Safety Net:CONNECTeDD

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 4,038 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
4,038
试验地点
2
主要终点
Develop,implement and evaluate a primary care-based,patient navigation program using patient navigators in the Community Health Centers. We will investigate the effect of this intervention on timing and quality of cancer-related care

研究概览

简要总结

The Boston University Medical Center, funded by the National Cancer Institutes will train health workers at six of its affiliated Community Health Centers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial.

This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and Cervical cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, satisfaction with patient's care and quality of life.

详细描述

Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer. Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care. This combination of patient empowerment and engagement is referred to as "activation." The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. We will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained patient Navigators who work within one of the six affiliated Community Health Centers. We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation, and total costs. Project findings will inform national policy regarding patient navigation for cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Receive care at one of the 6 participating community Health centers
  • Have received a positive breast or colorectal cancer screening test requiring follow-up on a different day
  • Have been newly diagnosed with breast or colorectal cancer
  • Have received notification by the provider of an abnormal breast or colorectal screening result

排除标准

  • Cognitively impaired
  • Institutionalized (nursing home, incarcerated)
  • Children <18
  • Actively involved in cancer treatment at time of presentation
  • Currently or previously navigated with (a) navigation documented in the medical record or (b) patient can articulate that they are in a navigation program or case management program for cancer

结局指标

主要结局

Develop,implement and evaluate a primary care-based,patient navigation program using patient navigators in the Community Health Centers. We will investigate the effect of this intervention on timing and quality of cancer-related care

时间窗: 4 years

次要结局

  • Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs(4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Battaglia, Tracy

Assistant Professor

Boston Medical Center

研究点 (2)

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