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，这是世界上排名第一的慢性病危险因素。的 美国预防服务工作组和 2017 年美国心脏病学会/American Heart 协会血压 (BP) 指南建议在诊所外测量血压以进行诊断 和高血压的管理。家庭血压监测（HBPM）涉及自我测量血压 由患者自行测量，是美国评估诊室外血压的最常用方法。指导方针 建议基于高质量的观察性研究，其中诊室外血压通常是 在单点获得的结果，观察到诊室外血压高的个体的发生率更高 心血管结局和全因死亡率增加，无论诊室血压水平如何。另外， 临床试验表明，HBPM 在短短 6-12 个月的时间内降低了诊所血压，尤其是 与疾病管理计划相结合。尚无研究评估其有效性 HBPM 在全国各地不同人群的常规临床实践中。此外，还缺乏 有关以下方面的数据：a) 使用 HBPM 是否会降低临床结果的风险； b) HBPM 对短期的影响 以及常规临床实践中的长期临床血压、临床惯性和用药依从性； c) 如何 临床医生和患者使用 HBPM。在过去约 10 年中，大约 400,000 名退伍军人测量了 作为 VA 远程医疗计划的一部分的家庭 BP。我们建议确定 18-90 岁的退伍军人 参加 HBPM 计划的不受控制的诊所 BP 和一群未参加 HBPM 计划的退伍军人。 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 参加 VA HBPM 计划的患者以及 HBPM 计划实施方式的变化 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（非 癌症死亡率和不良事件。在目标 2 中，我们将评估 HBPM 对诊所血压、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 与日常实践中使用 HBPM 相关的患者层面因素。结果将建立 a) 长期 HBPM 的益处，b) HBPM 与临床事件之间的关联，以及 c) 对重要疾病的影响 亚组。这些发现将为患者的选择和急需的随机试验的设计提供信息 对照试验评估 HBPM 与办公室高血压相比对临床结果的影响 管理。此外，确定与血压大幅降低和更多数量相关的因素 传输的家庭血压值（例如病例管理计划）可能会识别依从性的障碍 予以解决并为实施策略和 HBPM 在临床实践中的使用提供信息。拟议的 研究将回答对于在常规临床实践中实施 HBPM 至关重要的问题 最终目标是降低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.