Patient Navigators: Secondary Prevention in Underserved Coronary Disease Patients

描述（由申请人提供）：尽管他汀类药物、阿司匹林和β受体阻滞剂联合治疗可显著降低复发性冠状动脉疾病（CAD）事件和心血管死亡，并且是国家推荐的CAD二级预防的支柱，但这些药物在服务不足的人群中仍严重使用不足。来自服务不足背景的患者的住院后CAD病死率显著较高，部分原因是无法负担、获得和坚持预防性药物治疗。众所周知，确保支付药物费用的复杂系统很难操作，特别是对于服务不足的人群。患者导航器（PN）已被证明可以改善护理的可及性，并改善服务不足人群的癌症护理结果。我们在46例服务不足的CAD患者中进行的PN随机化初步研究的初步数据显示，与加强常规护理相比，随机分配至PN组的药物可及性和风险因素结局得到改善。因此，我们建议在360例（51%为美国黑人，26%为女性）低收入或低教育水平的CAD患者中进行一项更大规模的PN与EUC的随机对照试验，这些患者出院时没有任何药物保险。在EUC "对照"组中，提供者获得有关如何访问资源的信息，而在PN组中，PN定期使用引导式访谈与患者互动。具体目的是比较CAD出院后6个月和12个月时PN与EUC对（1）寻求初级护理随访的患者百分比，（2）坚持β受体阻滞剂、阿司匹林和他汀类药物治疗，（3）减少风险因素的影响（LDL-胆固醇，舒张压和收缩压，炎性细胞因子，血小板活化）和（4）使用肱动脉反应性流动介导的扩张证明改善的血管健康。将使用GLM和/或GEE技术进行分析。所有多变量分析将进行调整性别，CAD的性质，年龄，社会支持变量，行为，教育和社会经济地位，除了干预应急。这项研究为设计创新方法以解决服务不足人群中CAD结局持续存在的差异做出了重大贡献。本申请提出了一项随机对照试验，在没有任何药物保险的低收入或低教育水平冠心病患者出院时进行，终点集中在（1）寻求早期初级保健随访的服务不足患者的百分比改善，（2）坚持β受体阻滞剂、阿司匹林和他汀类药物治疗，（3）减少危险因素和（4）改善肱动脉反应性血流介导的扩张作为改善血管健康的代表。

DESCRIPTION (provided by applicant): Although statins, aspirin, and beta blocker therapy together markedly reduce recurrent coronary artery disease (CAD) events and cardiovascular death and are the mainstay of nationally recommended CAD secondary prevention, these agents remain seriously underutilized in underserved populations. Post-hospitalization CAD case fatality rates are significantly higher in patients from underserved backgrounds, attributed in part to failure to be able to afford, access, and adhere to preventive pharmacotherapy. Complex systems that assure payment for medications are known to be difficult to navigate, particularly for underserved populations. Patient navigators (PN) have been shown to improve access to care and improve outcomes in cancer care in underserved populations. Preliminary data from our randomized Pilot Study of PN in 46 underserved CAD patients show improved medication access and risk factor outcomes in the group randomized to the PN compared with enhanced usual care. We thus propose a larger randomized controlled trial of PN versus EUC in 360 (51% Black American, 26% female) low income or low educational level CAD patients discharged from the hospital without any medication insurance coverage. In the EUC "control" group, providers are given information about how to access resources whereas in the PN group, the PN interacts with patients regularly using guided interviews. The specific aims are to compare the impact of the PN vs EUC at 6 and 12 months post CAD discharge on (1) the percent of patients who seek primary care follow-up, (2) adhere to beta-blocker, aspirin, and statin therapy, (3) reduce risk factors (LDL-cholesterol, diastolic and systolic blood pressure, inflammatory cytokines, platelet activation) and (4) demonstrate improved vascular health using brachial artery reactivity flow-mediated dilatation. The analyses will be carried out using GLM and/or GEE techniques. All multivariable analyses will be conducted adjusting for sex, nature of the CAD, age, social support variables, behaviors, education and socioeconomic status, in addition to the intervention contingency. This study offers a significant contribution toward the design of innovative ways to address disparities that persist in CAD outcomes in underserved populations. This application proposes a randomized controlled trial in low income or low educational level coronary disease patients discharged from the hospital without any medication insurance coverage with endpoints focused on (1) improvement in the percent of underserved patients who seek early primary care follow-up, (2) adherence to beta- blocker, aspirin, and statin therapy, (3) reduction in risk factors and (4) improvement in brachial artery reactivity flow-mediated dilatation as a proxy for improved vascular health.