Administrative Supplement: Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-income and Minority Hypertensive Patients

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Summary African American and low-income populations bear a disproportionate burden of dementia and have been underrepresented in trials of cognitive impairment. The Systolic Blood Pressure Intervention Trial (SPRINT) showed that an intensive blood pressure (BP) intervention (target systolic BP <120 mmHg) lowered the risk of cognitive impairment compared to a standard BP intervention (systolic BP target <140 mmHg). A next important step is to determine how the successful SPRINT intensive blood pressure intervention can be implemented in real-world clinic settings to prevent cognitive decline. The goal of the parent trial (IMPACTS- MIND: R33AG068481) is to test a multifaceted strategy for implementing an intensive BP intervention protocol adapted from SPRINT targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income hypertensive patients in resource-constrained primary care practices. We have partnered with 36 federally qualified health center clinics (FQHCs) in Louisiana and Mississippi to conduct a cluster-randomized trial to test a multifaceted implementation strategy for an intensive BP intervention on decline in cognitive function and implementation outcomes over an average of 42 months. To date and despite the pandemic and major hurricanes, we have recruited and cognitively assessed 399 of an expected 1,260 diverse participants, and data collection and intervention delivery are ongoing. The proposed administrative supplement will accomplish two major objectives in support of the parent trial objectives and specific aims: 1) add 12 additional primary care clinics (clusters) in order to speed up recruitment, enrich the study sample with older participants who are more likely to experience cognitive change, and increase statistical power; and 2) provide antihypertensive medications directly to intervention participants at no cost to improve the effectiveness of the intervention, increase the net difference in BP reduction between groups, and improve retention. Overall, this administrative supplement application is in line with and supports the original objective and aims of the parent study and will improve trial conduct by: increasing speed of recruitment, enriching the sample for participants more likely to have changes in the outcome of interest, increasing statistical power, increasing the effectiveness of the intervention, and improving retention. The IMPACTS-MIND Data and Safety Monitoring Board (DSMB) has recently made the following three recommendations for the trial (report attached): 1) adding additional sites, 2) recruiting older participants, and 3) increasing the systolic BP separation by treatment arm. All of these recommendations will be addressed by the proposed supplement objectives.