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 (1) and reducing 2 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.

Public Health Relevance

Improving blood pressure (BP) control may represent an important public health strategy for lowering the risk of dementia. We hypothesize that a health-system wide approach with home BP monitoring and a ?virtual? collaborative care clinic will safely and effectively lower BP and slow age-related decline in cognition while reducing cardiovascular events and risk, mortality, and health care utilization. If this approach effectively overcomes the numerous barriers to effective BP control, it would have significant public health implications.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Project #
1R61AG068483-01
Application #
10045856
Study Section
Special Emphasis Panel (ZAG1)
Program Officer
Salive, Marcel
Project Start
2020-08-01
Project End
2021-07-31
Budget Start
2020-08-01
Budget End
2021-07-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Kansas
Department
Neurology
Type
Schools of Medicine
DUNS #
016060860
City
Kansas City
State
KS
Country
United States
Zip Code
66160