Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)

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SPRINT,5 and its accompanying cognitive-focused substudy SPRINT-MIND recently showed that blood pressure control (goal SBP<120 mm Hg) reduced incident mild cognitive impairment as well as a combined outcome of MCI and dementia. Divergence in opinion among experts and professional societies about BP goals still remain due to the concerns of potential harms. There is a clear need to implement new practical approaches to control blood pressure in clinical practice and test their effectiveness. Pragmatic clinical trials embedded in health systems (ePCTs) offer a unique opportunity to study the effectiveness of implementation of evidence- based interventions in real-world clinical settings. Our team is currently conducting ICD-Pieces (NCT02587936), the largest ePCT in patients with the coexistent chronic conditions of chronic kidney disease, hypertension and diabetes as part of a demonstration project in the NIH Health Care Systems Research Collaboratory. We now propose the Preventing Cognitive Decline by Reducing BP Target Trial (PCOT), to examine the effects of lowering BP to less than 130/80 upon the incidence of cognitive decline and dementia. Our main hypothesis is that patients who receive care with a collaboratory model that combines clinical decision support and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care. In the Planning Phase (R61) of this proposal we will build on our existing research infrastructure for pragmatic clinical trials to establish a collaboratory with 5 large health systems to conduct an ePCT to improve blood pressure control among adults with hypertension. We will develop readiness to deliver patient-centered processes to improve blood pressure control and to test for cognitive decline and dementia. In the Implementation Phase (R33) we will conduct a randomized pragmatic clinical trial to determine the impact of clinical decision support and team-based BP management in primary care practices compared to usual care on cognitive impairment and dementia. We will assess the benefits and harms of BP lowering as well as its impact on quality of life and patient-centered outcomes. The existent research infrastructure and lessons learned from ongoing work of our team conducting pragmatic trials in diverse health systems serving ethnically and socioeconomic diverse patients provide a firm foundation for the current study. This trial is pragmatic with evidence-based interventions informed by patients and delivered in primary care settings by the clinical teams of the health systems using information technology tools. The outcomes are relevant to major stakeholders including patients, families, clinicians and health systems. Lessons learned from this trial should be generalizable to other health settings to improve BP control and test optimal strategies to reduce cognitive impairment and dementia. 1