SMBP Study: Improving High Blood Pressure in Older Adults With Multiple Chronic Diseases

The purpose of the study is to compare the effects of self-measured blood pressure (SMBP) with conventional clinical support (SMBP-conventional) and SMBP with clinical pharmacist support (SMBP-pharmacist) on two outcomes among older adults living with multiple chronic diseases: systolic blood pressure (primary outcome), and self-reported treatment burden in selfcare (secondary outcome).

The primary outcome will be change in systolic BP after 12 months of follow-up. The primary hypothesis is that systolic BP will be significantly improved (i.e. lowered) in older adult patients living with multiple chronic diseases from primary care clinics randomized to the SMBP-pharmacist group compared to primary care clinics randomized to SMBP-conventional. The investigators further hypothesize this improvement will also occur within the two subgroups (i.e., rural, older patients and Black/African American, older patients).

STUDY DESIGN This is a multi-center, cluster-randomized, parallel-group, superiority, pragmatic trial testing two ways of addressing uncontrolled hypertension in older adults (SMBP-conventional vs SMBP-pharmacist). The investigators have designed the study to follow CONSORT 2010 guidelines for conducting randomized clinical trials. This is a pragmatic clinical trial with minimal exclusion criteria in order to facilitate the generalizability and practical application of findings. Further, the study's approach to data collection is also highly pragmatic in that primary, secondary, exploratory, and implementation outcomes as well as fidelity measures will be collected in part through clinic medical records and Medicare data. The unit of randomization is the primary care clinic with clinics stratified by healthcare system type (academic, independent, community health center). The study team chose the primary care clinic as the unit of randomization to avoid contamination within clinics that could occur with patient- or provider-level randomization.

CLINIC ELIGIBILITY AND RECRUITMENT To be eligible, clinics need to affiliate with one of the healthcare systems or practice-based research networks (PBRNs) participating in the study, provide primary care services to adults at least 65 years of age, staff providers who prescribe medications (including physicians [MDs and DOs] and advanced practice providers), and have access to patient-level electronic medical record data (for purposes of data collection and determining clinic and patient eligibility). Clinics eligible for the study will specialize in family medicine, internal medicine, or geriatrics. Clinics located in rural zip codes according to RUCA (rural-urban commuting area) categories 4-9 will be prioritized for recruitment into the study as well as clinics where at least 35% of the patients 65+ years of age are identified in healthcare system/PBRN records as Black/African American and/or identify as Black/African American in a mixed-race category.