Home Blood Pressure Outcomes Evaluation Study (HOMESTEAD)

家庭血压结果评估研究 (HOMESTEAD)

• 批准号: 10619516
• 负责人: Paul Englund Drawz
• 金额: $ 47.19万
• 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/10619516
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adherence; Adult; Adverse event; 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; Provider; Race; Randomized, Controlled Trials; Recommendation; Reporting; Risk; Risk Factors; Risk Reduction; Site; Socioeconomic Status; Subgroup; Time; United States Preventative Services Task Force; Variant; Veterans; adverse event risk; adverse outcome; blood pressure medication; blood pressure reduction; clinical practice; clinical risk; cohort; college; comorbidity; design; effectiveness evaluation; health data; hypertension control; implementation strategy; improved; medication compliance; mortality; participant enrollment; programs; routine practice; sex; telehealth; transmission process

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，这是世界上头号慢性病风险因素。这个 美国预防服务工作组和2017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血压以诊断 和高血压的管理。家庭血压监测(HBPM)包括自我测量血压 这是美国评估外出BP最常用的方法。指导方针 建议是基于高质量的观察性研究，在这些研究中，不在办公室的BP通常 在单点获得，并观察到外出高血压的人有更高的发病率 心血管结果和全因死亡率的增加，与办公室血压水平无关。另外， 临床试验表明，HBPM在短短6-12个月的时间内降低临床血压，尤其是 当与疾病管理计划相结合时。目前还没有研究评估这种药物的有效性。 HBPM在全国各地不同人群的常规临床实践中。此外，还有一个缺乏 关于以下方面的数据：a)HBPM的使用是否降低了对临床结果的风险；b)HBPM对短期和长期的 和长期临床血压、临床惰性和常规临床实践中的用药依从性；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40万退伍军人测量到 家庭BPS是退伍军人管理局远程医疗计划的一部分。我们建议将18-90岁的退伍军人认定为 不受控制的诊所BP参加了HBPM计划，以及一群没有参加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。该提案将利用大量的 参加退伍军人管理局HBPM计划的患者以及HBPM计划实施方式的变化 在退伍军人事务部的各个地点。在目标1中，我们将评估HBPM对主要不良心血管事件的影响，非 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 用药强度和用药依从性。在目标3中，我们将确定设施、提供商和 与常规实践中使用HBPM相关的患者水平因素。结果将建立a)长期 HBPM的好处，b)HBPM与临床事件之间的联系，以及c)在 子组。这些发现将为患者的选择和急需的随机设计提供信息 评价HBPM与办公室高血压对临床结果影响的对照试验 管理层。此外，确定与BP更大幅度降低和更多数量的 传输的家庭BP值，例如病例管理程序，可以识别遵守的障碍，这可以 解决并告知实施战略以及HBPM在临床实践中的使用。建议数 研究将回答对在常规临床实践中实施HBPM至关重要的问题 最终目标是降低与高血压相关的发病率和死亡率。