Patient Navigators: Secondary Prevention in Underserved Coronary Disease Patients

描述(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显著减少了复发的冠状动脉疾病(CAD)事件和心血管死亡，并且是国家推荐的CAD二级预防的主要手段，但这些药物在服务不足的人群中仍然严重未得到充分利用。住院后冠心病病死率在医疗服务不足的患者中显著较高，部分归因于未能负担得起、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)已被证明在服务不足的人群中改善了获得护理的机会并改善了癌症护理的结果。我们对46名服务不足的CAD患者进行的PN随机试点研究的初步数据显示，与加强的常规护理相比，随机接受PN的患者的用药机会和风险因素结果都有所改善。因此，我们建议在360名(51%美国黑人，26%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和EUC的随机对照试验，这些患者没有任何药物保险。在EUC“控制”组中，提供者被给予关于如何获得资源的信息，而在PN组中，PN通过引导性访谈定期与患者互动。具体目的是比较在CAD出院后6个月和12个月接受PN和EUC治疗的患者在以下方面的影响：(1)寻求初级保健随访的患者百分比，(2)坚持接受β-受体阻滞剂、阿司匹林和他汀类药物治疗的患者，(3)降低风险因素(低密度脂蛋白-胆固醇、舒张压和收缩压、炎性细胞因子、血小板激活)和(4)证实使用反应性血流调节扩张技术改善血管健康的情况。将使用GLM和/或GEE技术进行分析。所有多变量分析将根据性别、冠心病的性质、年龄、社会支持变量、行为、教育和社会经济地位进行调整，以及干预偶发事件。这项研究为设计创新的方法来解决在服务不足的人群中持续存在的CAD结果的差异做出了重大贡献。这项申请建议对没有任何药物保险的出院低收入或低教育水平的冠心病患者进行随机对照试验，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的改善，(2)坚持使用β-受体阻滞剂、阿司匹林和他汀类药物，(3)减少风险因素，以及(4)改善臂动脉反应性血流介导的扩张，以此作为改善血管健康的指标。

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.