Remote Monitoring and Virtual Collaborative Care for Hypertension Control to Prevent Cognitive Decline

积极管理高血压（HTN）可以减少认知障碍、痴呆、阿尔茨海默病和相关痴呆（ADRD）的发生率。尽管如此，四分之三患有HTN的老年人未能达到血压（BP）目标。多种障碍阻碍了患者及其临床医生优化老年患者血压的努力。我们相信，通过重组当前HTN管理模式，利用新技术、实施科学和基于团队的系统范围流程，这些障碍在很大程度上是可以克服的。鉴于HTN的高流行率，这些卫生系统范围内的努力可能对ADRD的流行率产生重大影响。作为预防ADRD的潜在公共卫生方法，我们提出了一项实用实施研究，测试在两个卫生系统中使用家庭血压监测和“虚拟”协作护理诊所（vCCC）的卫生系统范围战略。我们假设这种方法将安全有效地降低血压，减缓与年龄相关的认知能力下降，同时降低心血管风险、死亡率和医疗保健利用率。这项研究将分为两个阶段。第一阶段（R61）的主要目标是证明可行性，评估患者的可接受性和满意度，并改进流程和程序，以便在卫生系统层面大规模提供vCCC。我们将获得IRB的批准，让主要利益相关者（卫生系统、PCP和患者）参与进来，优化电子健康记录（EHR）流程（警报和转诊），改进护理算法和流程，并在3个初级保健诊所启动干预措施。我们将招募60名患者进行为期3个月的vCCC治疗，以评估重要的实施结果并告知进行/不进行的决定。在完成第一阶段的里程碑后，我们将扩大项目规模，以满足在两个不同的卫生系统（堪萨斯大学和犹他卫生系统）实施干预的第二阶段（R31）目标，随机分配n=1000名患者到vCCC和对照组（常规护理和教育），为期2年。我们将评估vCCC在实现血压目标（1º）和降低认知能力下降、主要不良心血管事件、动脉粥样硬化性心血管疾病风险、医疗资源利用和死亡率2º指标方面的有效性。我们还将评估与大规模采用相关的关键实施结果，包括可行性、可接受性、适当性和采用意图。我们的多学科合作团队和与卫生系统的合作历史为这项研究提供了良好的基础。我们在两家机构的ADRD预防、HTN管理和EHR重点实用试验的临床试验方面拥有必要的专业知识。随着我们的降压项目在两个卫生系统中的成功实施，我们将很好地将该模型扩展到多个卫生系统，以便在更大的队列中对降低ADRD发病率进行明确的测试。

Aggressive management of hypertension (HTN) may reduce the incidence of cognitive impairment, dementia, and Alzheimer’s disease and related dementias (ADRD). Despite this, 3 out of 4 older adults with HTN fail to reach blood pressure (BP) goals. Multiple barriers conspire against the efforts of patients and their clinicians to optimize BP in older patients. We believe these barriers are largely surmountable by reorganization of the current model of HTN management and leveraging new technology, implementation science, and team-based system-wide processes. Given the high prevalence of HTN, these health system-wide efforts may have a large impact on the prevalence of ADRD. As a potential public health approach to ADRD prevention, we propose a pragmatic-implementation study testing a health-system wide strategy leveraging home BP monitoring and a “virtual” Collaborative Care Clinic (vCCC) deployed in two health systems. We hypothesize this approach will safely and effectively lower BP and slow age-related decline in cognition while reducing cardiovascular risk, mortality, and health care utilization. The study will be structured in two phases. The primary objective of Phase I (R61) is to demonstrate feasibility, assess patient acceptability and satisfaction, and refine processes and procedures to enable high scale delivery of the vCCC at the health system level. We will obtain IRB approval, engage key stakeholders (health system, PCP’s and patients), optimize electronic health record (EHR) processes (alerts and referrals), refine care algorithms and processes, and launch the intervention in 3 primary care clinics. We will enroll n= 60 patients to vCCC for 3 months to assess important implementation outcomes and inform go / no-go decisions. Upon achieving the milestones of Phase I, we will scale the program to meet the Phase II (R31) objective of implementing the intervention across two different health systems (Universities of Kansas and Utah Health Systems) to randomize n=1000 patients to vCCC vs. controls (usual care with education) for 2 years. We will assess effectiveness of vCCC in achieving BP goals (1º) and reducing 2º measures of cognitive decline, major adverse cardiovascular events, atherosclerotic cardiovascular disease risk, health care resource utilization, and mortality. We will also assess critical implementation outcomes relevant to wide-scale adoption including feasibility, acceptability, appropriateness, and intention to adopt. Our multidisciplinary collaborative team and history of collaboration with our health system provides an excellent foundation for this study. We have the necessary expertise in clinical trials for ADRD prevention, HTN management, and EHR focused pragmatic trials at both institutions. With the successful implementation of our BP lowering program across the two health systems, we will be well-positioned to scale the model to multiple health systems for definitive testing on reducing the incidence of ADRD in a much larger cohort.