A Cardiometabolic Health Program LINKED with Clinical-Community Support and Mobile HEAlth TelemonitoRing in Underserved PopulaTionS (LINKED-HEARTS PROGRAM)

项目摘要/摘要 迫切需要在慢性病管理方面进行创新，以有效控制高血压和 糖尿病，影响数百万美国人的疾病。失控的HTN和糖尿病导致心血管疾病 疾病、中风、慢性肾脏疾病(CKD)和过早死亡。然而，这些条件都很差。 尽管有有效和负担得起的治疗方法，但仍受到控制。当务之急是缩小差距 在管理和控制慢性病和使初级保健更方便服务不足的人方面 人口。与白人成年人相比，黑人和西班牙裔成年人更容易受到HTN和糖尿病的影响。 他们还经历了更多不利的健康社会决定因素，包括无法获得可靠的 交通工具和零散的初级保健服务。包括社区卫生工作者在内的基于团队的护理 药剂师是改善HTN和糖尿病控制的“最佳实践”。远程医疗已经成为一种 最大限度地减少初级保健中断的努力的基石，并可以通过远程患者来增强 监控设备。新冠肺炎大流行促使人们做出努力，增加及时和适当获取 通过重新设计初级保健服务，使其以患者为中心并启用数字技术。斯菲格莫之家，一个 远程患者远程监护解决方案，与有效的血压(BP)和血糖监测相连接 设备是改善HTN和糖尿病患者自我管理的一种很有前途的解决方案。我们设计了 关联心脏计划，一种创新的、理论派生的、以患者为中心的多层次干预 解决影响慢性病管理的个人和社区层面的社会决定因素。这个 联心计划侧重于解决准入的结构性问题，并包括自我衡量的 BP(SMBP)和血糖远程监测平台；基于团队的护理，包括一名药剂师和社区 卫生工作者和提供者层面的干预措施。使用混合型I类效能实施设计，我们的 建议的具体目标是1)比较连接心脏计划与单独使用SMBP的效果 改善血压控制(收缩压140/90毫米汞柱)并改善6个月和12个月以患者为中心的结果， 在一项对患有未控制的HTN和糖尿病或CKD的成年人进行的整群随机对照试验中。2)使用 实用稳健的实施和可持续发展模型(PRISM)，以评估覆盖范围、采用、 在随机化后12个月和24个月维持连接心脏计划，并探索背景 与计划的采用和维护相关的因素。我们将招收600名成年人，分成16个小组 做法包括联邦合格的医疗保健中心。通过早期和持续的利益相关者参与 与卫生系统领导人、提供者、患者和我们的社区一起，我们寻求弥合广泛的“知识鸿沟” 并减少慢性疾病的差异。我们还提出了一项全面的传播战略，以达到 批评受众，并实现买入和政策变化。

Project Summary/Abstract Innovation in chronic disease management is urgently needed to effectively control hypertension (HTN) and diabetes, conditions which affect millions of Americans. Uncontrolled HTN and diabetes cause cardiovascular disease, stroke, chronic kidney disease (CKD), and premature death. However, these conditions are poorly controlled despite the availability of effective and affordable therapy. A pressing priority is reducing disparities in the management and control of chronic diseases and making primary care more convenient for underserved populations. Black and Hispanic adults are disproportionately affected by HTN and diabetes than White adults. They also experience more adverse social determinants of health, including a lack of access to reliable transportation and fragmented access to primary care. Team-based care including community health workers and pharmacists are “best practices” in improving HTN and diabetes control. Telehealth has become a cornerstone of efforts to minimize disruptions in primary care and can be enhanced with remote patient monitoring devices. The COVID-19 pandemic has spurred efforts to increase access to timely and appropriate care through re-engineering primary care to be patient-centered and digitally-enabled. Sphygmo Home, a remote patient telemonitoring solution that links with validated blood pressure (BP) and glucose monitoring devices is a promising solution to improve patient's self-management of HTN and diabetes. We have designed the LINKED-HEARTS Program, an innovative, theoretically derived, patient-centered, multi-level intervention to address individual and community-level social determinants that affect chronic disease management. The LINKED-HEARTS Program focuses on addressing structural issues of access and includes a self-measured BP(SMBP) and blood glucose telemonitoring platform; team-based care including a pharmacist and community health worker and provider-level interventions. Using a hybrid type I effectiveness-implementation design, our proposed specific aims are 1) To compare the effect of the LINKED-HEARTS Program versus SMBP alone in improving BP control (systolic BP<140/90 mm Hg) and improving patient-centered outcomes at 6 and 12 months, in a cluster-randomized controlled trial of adults with uncontrolled HTN and either diabetes or CKD. 2) To use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the reach, adoption, maintenance of the LINKED-HEARTS program at 12 and 24 months post-randomization and explore contextual factors that associated with adoption and maintenance of the program. We will enroll 600 adults, clustered in 16 practices including federally qualified healthcare centers. Through early and continued stakeholder engagement with health system leaders, providers, patients, and our community, we seek to close the wide “know-do-gap” and reduce chronic disease disparities. We also propose a comprehensive dissemination strategy to reach critical audiences and achieve buy-in and policy change.