RCT of Primary Care-based Patient Navigation-Activation

描述(由申请人提供)： 癌症治疗和结果的差异已被广泛记录在患者的种族、民族和社会经济地位(SES)上。患者导航是解决这些差异的一种潜在的强有力的干预措施，但尚未得到严格评估。该项目的主要目的是使用随机对照研究设计评估以初级保健为基础的患者导航激活计划对癌症相关护理质量的影响。一个关键目标是评估服务不足人群的成员是否比面临较少访问障碍的患者从导航中获得更大好处。第六，将招募主要服务于少数族裔和低收入人群的大型市中心诊所。在实施干预措施之前，将评估实践的需求，评估患者障碍，并制定导航员课程和培训手册。这些诊所的患者将使用在每个诊所建立的乳腺癌和结直肠癌筛查患者登记来招募。同意接受乳房或结直肠筛查结果异常的患者将被随机分配到常规护理或患者导航。训练有素的社区卫生工作者将评估患者障碍，帮助患者克服这些障碍，并指导患者与医生沟通。患者的主要结果将是进行明确诊断测试的时间和完成癌症治疗的时间、遵守建议、接受与指南一致的护理、满意度和生活质量。次要结果包括种族/民族、收入或健康素养的不同影响，患者激活的中介影响，以及导航和护理成本。该项目的发现对设计和实施癌症患者导航程序以及旨在消除癌症治疗差异的干预措施的国家政策具有影响。

DESCRIPTION (provided by applicant): Disparities in cancer treatment and outcomes have been extensively documented by the race, ethnicity, and socioeconomic status (SES) of the patient. Patient navigation represents a potentially powerful intervention for addressing these disparities, but has not been rigorously evaluated. The primary aim of this project is to assess the impact of a primary care-based, patient navigation-activation program on cancer-related quality of care using a randomized controlled study design. A key aim assesses whether members of underserved populations derive greater benefit from navigation than do patients who face fewer access barriers. Six, large inner-city practices serving predominately minority and low-income populations will be recruited. Implementation of the intervention will be preceded by evaluation of the practices' needs, assessment of patient barriers, and development of a navigator curriculum and training manuals. Patients from these practices will be recruited using patient registries established in each practice for breast and colorectal cancer screening. Consenting patients with abnormal breast or colorectal screening results will be randomized to usual care or patient navigation. Well-trained community health workers, will assess patient barriers, assist patients in overcoming these barriers, and coach patients in communicating with their physicians. The primary patient outcomes will be time to a definitive diagnostic test and time to completion of cancer treatment, adherence to recommendations, receipt of guideline concordant care, satisfaction, and quality of life. Secondary outcomes include differential effects by race/ethnicity, income, or health literacy, mediating effects of patient activation, and costs of navigation and care. Findings from this project have implications for national policy related to the design and implementation of patient navigation programs for cancer and interventions designed to eliminate disparities in cancer treatment