Home Blood Pressure Outcomes Evaluation Study (HOMESTEAD)

项目摘要 超过1亿美国成年人患有高血压，这是世界上头号慢性疾病风险因素。的 美国预防服务工作组和2017年美国心脏病学会/美国心脏 血压协会（BP）指南建议在诊所外测量BP以进行诊断 和高血压的管理。家庭血压监测（HBPM）涉及BP的自我测量 这是在美国评估门诊外血压的最常用方法。该指南 这些建议是基于高质量的观察性研究，其中门诊BP通常 在一个单一的点获得，观察到具有高门诊血压的个体具有更高的 心血管结局和全因死亡率增加，无论办公室血压水平如何。此外，本发明还 临床试验已经证明HBPM在短的6-12个月的时间内降低了临床血压， 与疾病管理计划相结合。没有研究评估 HBPM在全国不同人群中的常规临床实践。此外，缺乏 关于以下方面的数据：a）HBPM的使用是否降低了临床结局的风险; B）HBPM对短期和长期的影响。 以及常规临床实践中的长期临床BP、临床惰性和药物依从性;以及c）如何 临床医生和患者使用HBPM。在过去的10年里，大约有40万退伍军人测量了 家庭BP作为VA远程医疗计划的一部分。我们建议将18-90岁的退伍军人确定为 未受控制的诊所BP参加了HBPM计划，而退伍军人队列没有参加HBPM计划。 我们将把远程医疗数据与临床和结果数据联系起来。该提案将利用大量的 入组VA HBPM计划的患者以及实施HBPM计划的方式的变化 跨VA站点。在目标1中，我们将评估HBPM对主要不良心血管事件的影响， 癌症死亡率和不良事件。在目标2中，我们将评估HBPM对临床血压的影响， 药物强化和药物依从性。在目标3中，我们将确定设施、提供商和 在常规实践中与HBPM使用相关的患者水平因素。结果将确定a）长期 HBPM的益处，B）HBPM与临床事件之间的关联，以及c）重要的 分组。这些发现将为急需的随机化研究的患者选择和设计提供信息。 一项对照试验，评价HBPM与办公室高血压相比对临床结局的影响 管理此外，确定与BP更大幅度降低和更多的 传输的家庭BP值（例如病例管理程序）可以识别依从性的障碍， 得到解决并为实施策略和HBPM在临床实践中的使用提供信息。拟议 研究将回答在常规临床实践中实施HBPM的关键问题， 最终目标是降低与高血压相关的发病率和死亡率。

PROJECT ABSTRACT Over 100 million US adults have hypertension, the number one chronic disease risk factor in the world. The United States Preventive Services Task Force and the 2017 American College of Cardiology/American Heart Association blood pressure (BP) guidelines recommends measuring BP outside of the clinic for the diagnosis and management of hypertension. Home blood pressure monitoring (HBPM) involves self-measurement of BP by the patient and is the most common method for assessing out-of-office BP in the US. The guideline recommendations are based on high-quality observational studies in which out-of-office BP was typically obtained at a single point and individuals with high out-of-office BP were observed to have higher rates of cardiovascular outcomes and increased rates of all-cause mortality, regardless of office BP levels. Additionally, clinical trials have demonstrated that HBPM reduces clinic BP over short 6-12 month time frames, especially when combined with disease management programs. There are no studies evaluating the effectiveness of HBPM in routine clinical practice in a diverse population from across the country. Additionally, there are a lack of data on: a) whether use of HBPM reduces risk for clinical outcomes; b) the impact of HBPM on both short- and long-term clinic BP, clinical inertia, and medication adherence in routine clinical practice; and c) how clinicians and patients utilize HBPM. Over the last ~10 years, approximately 400,000 Veterans have measured home BPs as part of the VA’s telehealth program. We propose to identify Veterans age 18-90 years with uncontrolled clinic BP enrolled in HBPM programs and a cohort of Veterans not enrolled in HBPM programs. We will link telehealth data to clinical and outcome data. The proposal will make use of the large number of patients enrolled in the VA’s HBPM program and the variation in how the HBPM program is implemented across VA sites. In Aim 1, we will evaluate the effect of HBPM on major adverse cardiovascular events, non- cancer mortality, and adverse events. In Aim 2, we will assess the impact of HBPM on clinic BP, BP medication intensification, and medication adherence. In Aim 3, we will determine facility-, provider-, and patient-level factors associated with use of HBPM in routine practice. Results will establish a) the long-term benefits of HBPM, b) the association between HBPM and clinical events, and c) the effects in important subgroups. These findings will inform selection of patients for and the design of a much-needed randomized controlled trial evaluating the effect of HBPM on clinical outcomes compared to office-based hypertension management. Additionally, identifying factors associated with greater reductions in BP and greater number of home BP values transmitted, such as case management programs, may identify barriers to adherence that can be addressed and inform implementation strategies and the use of HBPM in clinical practice. The proposed study will answer questions critically important to implementation of HBPM in routine clinical practice with the ultimate goal of reducing the morbidity and mortality associated with hypertension.