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

远程监控和虚拟协作护理控制高血压以防止认知能力下降

基本信息

批准号：
10451202
负责人：
JEFFREY Murray BURNS
金额：
$ 261.89万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10451202
关键词：
Adherence Administrator Adopted Adoption Adverse effects Agreement Algorithms Alzheimer&apos s disease related dementia American American Heart Association Antihypertensive Agents Atherosclerosis Blood Pressure Blood Pressure Monitors Cardiology Cardiovascular system Caring Clinic Clinic Visits Clinical Pharmacists Clinical Trials Cognition Collaborations Dementia Dose Education Elderly Electronic Health Record Enrollment Ensure Event Foundations Frequencies Future Goals Guidelines Health system Healthcare High Prevalence Home Home Blood Pressure Monitoring Hypertension Impaired cognition Incentives Incidence Institution Institutional Review Boards Intention Intervention Kansas Knowledge Logistics Manuals Measures Modeling Outcome Patients Pharmacists Pharmacy facility Phase Positioning Attribute Prevalence Prevention Primary Health Care Procedures Process Public Health Randomized Reading Recording of previous events Resources Risk Safety Sample Size Secure Site Structure System Testing Time Transportation Universities Utah age related base blood pressure reduction blood pressure regulation cardiovascular disorder risk cardiovascular risk factor clinical care cohort collaborative care college cost dashboard dementia risk design effectiveness evaluation effectiveness implementation study effectiveness study effectiveness trial health care service utilization human old age (65+)hypertension control implementation outcomes implementation science implementation study improved mild cognitive impairment mobile application mortality multidisciplinary new technology older patient operation participant enrollment phase 2 testing pragmatic trial prevent primary outcome programs public health relevance recruit remote monitoring satisfaction secondary outcome shared decision making treatment as usual virtual

Adherence Administrator Adopted Adoption Adverse effects Agreement Algorithms Alzheimer&apos s disease related dementia American American Heart Association Antihypertensive Agents Atherosclerosis Blood Pressure Blood Pressure Monitors Cardiology Cardiovascular system Caring Clinic Clinic Visits Clinical Pharmacists Clinical Trials Cognition Collaborations Dementia Dose Education Elderly Electronic Health Record Enrollment Ensure Event Foundations Frequencies Future Goals Guidelines Health system Healthcare High Prevalence Home Home Blood Pressure Monitoring Hypertension Impaired cognition Incentives Incidence Institution Institutional Review Boards Intention Intervention Kansas Knowledge Logistics Manuals Measures Modeling Outcome Patients Pharmacists Pharmacy facility Phase Positioning Attribute Prevalence Prevention Primary Health Care Procedures Process Public Health Randomized Reading Recording of previous events Resources Risk Safety Sample Size Secure Site Structure System Testing Time Transportation Universities Utah age related base blood pressure reduction blood pressure regulation cardiovascular disorder risk cardiovascular risk factor clinical care cohort collaborative care college cost dashboard dementia risk design effectiveness evaluation effectiveness implementation study effectiveness study effectiveness trial health care service utilization human old age (65+)hypertension control implementation outcomes implementation science implementation study improved mild cognitive impairment mobile application mortality multidisciplinary new technology older patient operation participant enrollment phase 2 testing pragmatic trial prevent primary outcome programs public health relevance recruit remote monitoring satisfaction secondary outcome shared decision making treatment as usual virtual

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项目摘要

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.

高血压（HTN）的积极管理可能会降低认知障碍，痴呆症和阿尔茨海默氏病和相关痴呆症（ADRD）的发生率。尽管如此，HTN的4名老年人中有3个未能达到血压（BP）目标。多个障碍违背了患者及其临床医生在老年患者中优化BP的努力。我们认为，通过重组HTN管理模型并利用新技术，实施科学和基于团队的全系统范围的流程，可以在很大程度上可以克服这些障碍。鉴于HTN的高流行率，这些卫生系统范围内的努力可能会对ADRD的患病率产生很大的影响。作为预防ADRD的潜在公共卫生方法，我们提出了一项务实的实施研究，测试了一种利用家庭BP监测的健康系统广泛的战略，以及部署在两个卫生系统中的“虚拟”协作护理诊所（VCCC）。我们假设这种方法将安全有效地降低BP，并降低与年龄相关的认知下降，同时降低心血管风险，死亡率和医疗保健利用率。该研究将分为两个阶段。第一阶段（R61）的主要目的是证明可行性，评估患者的可接受性和满意度，以及完善过程和程序，以使VCCC在卫生系统级别上进行高度交付。我们将获得IRB批准，聘请关键利益相关者（卫生系统，PCP和患者），优化电子健康记录（EHR）流程（警报和推荐），改进护理算法和流程，并在3家初级保健诊所中启动干预。我们将注册n = 60名患者参加VCCC 3个月，以评估重要的实施成果并告知GO/NO-GO决定。在达到第一阶段的里程碑后，我们将扩展该计划，以满足II阶段（R31）的目标，即在两个不同的卫生系统（堪萨斯州和犹他州卫生系统的大学）实施干预措施，以将n = 1000名患者随机化为VCCC与对照（与教育的常规护理）2年。我们将评估VCCC在实现BP目标（1º）中的有效性，并降低2º认知能力下降，主要不良心血管事件，动脉粥样硬化心血管疾病风险，医疗保健资源利用和死亡率。我们还将评估与广泛采用有关的关键实施结果，包括可行性，可接受性，适当性和收养意图。我们的多学科合作团队和与您的卫生系统的合作历史为这项研究提供了绝佳的基础。我们在两个机构的ADRD预防，HTN管理和EHR务实试验方面具有必要的专业知识。随着在两个卫生系统中成功实施我们的BP降低计划，我们将有充分的位置将模型扩展到多个卫生系统，以确定对减少更大的队列中ADRD事件的确定性测试。