Home Blood Pressure Outcomes Evaluation Study (HOMESTEAD)

家庭血压结果评估研究 (HOMESTEAD)

• 批准号: 10364199
• 负责人: Paul Englund Drawz
• 金额: $ 49.43万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10364199
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adherence; Adult; Adverse event; Advisory Committees; Age; American; American Heart Association; Antihypertensive Agents; Blood Pressure; Cardiology; Cardiovascular system; Caring; Case Management; Case Manager; Cessation of life; Characteristics; Chronic Disease; Clinic; Clinical; Clinical Trials; Country; Data; Diagnosis; Disease Management; Effectiveness; Electrolytes; Enrollment; Ethnic Origin; Evaluation Studies; Event; Goals; Guidelines; Home; Home Blood Pressure Monitoring; Hypertension; Individual; Knowledge; Link; Measurement; Measures; Methods; Morbidity - disease rate; Nephrology; Observational Study; Outcome; Patient Selection; Patients; Persons; Pharmaceutical Preparations; Population Heterogeneity; Preventive service; Provider; Race; Randomized Controlled Trials; Recommendation; Reporting; Risk; Risk Factors; Site; Socioeconomic Status; Subgroup; Time; United States; Variant; Veterans; adverse event risk; adverse outcome; base; blood pressure medication; blood pressure reduction; clinical practice; clinical risk; cohort; college; comorbidity; design; effectiveness evaluation; hypertension control; implementation strategy; improved; medication compliance; mortality; programs; routine practice; sex; telehealth

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.

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疾病危险因素。这 美国预防服务工作队和2017年美国心脏病学院/美国心脏 协会血压（BP）指南建议在诊所外测量BP进行诊断 和高血压管理。家庭血压监测（HBPM）涉及BP的自我测量 由患者进行，是评估美国外部BP的最常见方法。指南 建议基于高质量的观察性研究，其中通常是室外BP 在一个点获得，观察到较高的外部BP的个体具有更高的速率 无论办公室BP水平如何，心血管结局和全因死亡率的增加。此外， 临床试验表明，HBPM在短短的6-12个月时间内降低了诊所BP，尤其是 与疾病管理计划结合使用。没有研究评估 来自全国潜水员人群的常规临床实践的HBPM。此外，还有一个缺乏 数据：a）HBPM的使用是否会降低临床结果的风险； b）HBPM对这两个简短的影响 以及长期的诊所BP，临床惯性和常规临床实践中的药物依从性； c）如何 临床医生和患者使用HBPM。在过去的大约10年中，大约有40万退伍军人测量了 作为VA远程医疗计划的一部分，主BPS。我们建议确定18-90岁的退伍军人 不受控制的诊所BP参加了HBPM计划，而一群未参加HBPM计划的退伍军人队伍。 我们将将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的HBPM计划的患者以及HBPM计划的实施方式的变化 跨VA站点。在AIM 1中，我们将评估HBPM对主要不良心血管事件的影响，非 - 癌症死亡率和不良事件。在AIM 2中，我们将评估HBPM对BP诊所BP的影响 用药加强和药物依从性。在AIM 3中，我们将确定设施，提供商和 与使用HBPM在常规实践中使用HBPM相关的患者级因素。结果将建立a）长期 HBPM的好处，b）HBPM与临床事件之间的关联，c）重要的影响 亚组。这些发现将为患者的选择提供信息，并设计了急需的随机性 与基于办公室的高血压相比，评估HBPM对临床结果的影响的对照试验 管理。另外，识别与BP减少和更多数量相关的因素 传输的家庭BP值，例如案例管理程序，可能会确定遵守的障碍 解决并为实施策略提供信息，并在临床实践中使用HBPM。提议 研究将回答有关在常规临床实践中实施HBPM至关重要的问题 降低与高血压相关的发病率和死亡率的最终目标。