Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)

Sprint，5和它附带的以认知为重点的子研究Sprint-Mind最近表明，血液 压力控制(目标SBP&lt；120毫米汞柱)减少了轻微认知损害事件以及 MCI的转归与痴呆。专家和专业团体对BP目标的看法分歧 由于对潜在危害的担忧，仍然存在。显然有必要实施新的实际办法。 目的：在临床实践中控制血压并检验其有效性。实用的临床试验嵌入在 卫生系统(EPCT)提供了一个独特的机会来研究证据实施的有效性-- 在真实世界的临床环境中进行干预。我们的团队目前正在进行ICD-Pieces (NCT02587936)，慢性肾脏疾病并存患者中最大的ePCT， 高血压和糖尿病是美国国立卫生研究院医疗保健系统研究示范项目的一部分 合作。我们现在建议通过减少BP目标试验(PCOT)来预防认知下降，以 检查血压降至130/80以下对认知功能下降和痴呆症发生率的影响。 我们的主要假设是，接受护理的患者采用结合临床的协作模式 在初级保健实践中提供的决策支持和基于团队的护理将有更好的血液 压力控制和轻度认知障碍和痴呆症的发生率低于患者 接受通常的医疗护理。 在本提案的规划阶段(R61)，我们将在现有研究基础设施的基础上进行构建 务实临床试验与5大卫生系统建立协作室进行ePCT改进 成人高血压患者的血压控制。我们将做好准备，以患者为中心 改善血压控制和测试认知衰退和痴呆症的过程。在 实施阶段(R33)我们将进行一项随机、务实的临床试验，以确定影响 与常规护理相比，初级保健实践中的临床决策支持和基于团队的BP管理 认知障碍和痴呆症。我们将评估BP降压的好处和危害以及它的 对生活质量和以患者为中心的结果的影响。 现有的研究基础设施和从我们的团队正在进行的工作中吸取的教训 在为不同种族和社会经济差异的患者服务的不同卫生系统中进行的务实试验提供了一个坚定的 为当前的研究奠定了基础。这项试验是务实的，由患者告知循证干预措施 并由卫生系统的临床团队使用信息技术在初级保健环境中提供 工具。结果与主要利益相关者有关，包括患者、家庭、临床医生和健康 系统。从这项试验中吸取的经验教训应该推广到其他卫生环境，以改善BP控制 并测试减少认知障碍和痴呆症的最佳策略。 1

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