Patient Navigators: Secondary Prevention in Underserved Coronary Disease Patients

描述（由申请人提供）：尽管他汀类药物、阿司匹林和受体阻滞剂联合治疗可显著减少冠心病（CAD）复发事件和心血管死亡，并且是国家推荐的冠心病二级预防的主要药物，但在服务不足的人群中，这些药物的使用率仍然严重不足。住院后冠心病病死率在服务不足背景的患者中明显更高，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，确保药物支付的复杂系统很难驾驭，特别是对于服务不足的人群。患者导航员（PN）已被证明可以改善服务不足人群获得护理的机会并改善癌症护理的结果。我们对46名服务不足的CAD患者进行的随机PN试点研究的初步数据显示，与增强的常规护理相比，随机分配到PN组的药物可及性和风险因素结果有所改善。因此，我们建议在360例（51%的美国黑人，26%的女性）低收入或低教育水平的冠心病患者中进行更大规模的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通过指导访谈定期与患者互动。具体目的是比较冠心病出院后6个月和12个月时PN与EUC对以下方面的影响：(1)寻求初级保健随访的患者百分比；(2)坚持β受体阻滞剂、阿司匹林和他汀类药物治疗；(3)降低危险因素（ldl -胆固醇、舒张压和收缩压、炎症细胞因子、血小板活化）；(4)通过肱动脉反应性血流介导扩张改善血管健康。分析将使用GLM和/或GEE技术进行。除干预偶然性外，所有多变量分析都将根据性别、CAD性质、年龄、社会支持变量、行为、教育和社会经济地位进行调整。这项研究为解决服务不足人群中持续存在的CAD结果差异的创新方法的设计提供了重大贡献。本申请提出了一项随机对照试验，在低收入或低教育水平的冠心病患者出院时没有任何药物保险覆盖，终点集中在(1)改善寻求早期初级保健随访的服务不足患者的百分比，(2)坚持-受体阻滞剂，阿司匹林和他汀类药物治疗，(3)降低危险因素；(4)改善肱动脉反应性，血流介导的扩张是改善血管健康的一个指标。

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.