Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)

通过降低血压目标试验 (PCOT) 预防认知能力下降

基本信息

批准号：
10045903
负责人：
MIGUEL A VAZQUEZ
金额：
$ 79.66万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10045903
关键词：
Acute Renal Failure with Renal Papillary Necrosis Adherence Adult Blood Tests Cardiovascular system Caring Cessation of life Chronic Chronic Kidney Failure Clinical Code Cognitive Communities Connecticut Dementia Development Diabetes Mellitus Diagnostic Drug Combinations Effectiveness Elderly Electrolytes Electronic Health Record Emergency department visit Enrollment Event Evidence based intervention Family Foundations Fracture Goals Guidelines Health Health Resources Health system Healthcare Systems Hospitalization Hospitals Hypertension Hypotension Impaired cognition Incidence Information Technology Intervention Intervention Studies Intervention Trial Life Measures Medical Medical center Meta-Analysis Minnesota Modeling Outcome Participant Patient-Focused Outcomes Patients Phase Physicians Population Population Heterogeneity Pragmatic clinical trial Primary Health Care Process Professional Organizations Quality of life Questionnaires Randomized Readiness Research Research Infrastructure Sample Size Syncope System Testing Texas United States National Institutes of Health Work adjudication base blood pressure reduction blood pressure regulation clinical decision support clinical practice cognitive function cognitive testing collaboratory effectiveness implementation study electronic data evidence base falls improved inclusion criteria instrument middle age mild cognitive impairment patient oriented pragmatic trial prevent primary care setting primary outcome recruit research clinical testing socioeconomics support tools systems research tool treatment as usual

项目摘要

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

Sprint，5及其伴随着认知的属性Sprint Mind最近表明血液压力控制（目标SBP <120 mm Hg）减少了入射的轻度认知障碍以及合并 MCI和痴呆症的结果。关于BP目标的专家和专业社会之间的意见分歧由于对潜在危害的关注，仍然存在。显然需要实施新的实用方法在临床实践中控制血压并测试其有效性。嵌入中的务实临床试验卫生系统（EPCTS）提供了一个独特的机会来研究实施证据的有效性 - 基于现实世界中的临床环境的干预措施。我们的团队目前正在进行ICD件（NCT02587936），是患有慢性肾脏疾病慢性疾病的患者中最大的EPCT，高血压和糖尿病作为NIH卫生保健系统研究中的演示项目的一部分协作。现在，我们提出通过将BP目标试验（PCOT）降低到的预防认知能力下降，检查将BP降低至130/80的影响对认知下降和痴呆的发生率。我们的主要假设是，与临床结合的协作模型接受护理的患者在初级保健实践中提供的决策支持和基于团队的护理将获得更好的血液与患者相比，压力控制和轻度认知障碍和痴呆症的发生率较低接受通常的医疗服务。在该提案的计划阶段（R61）中，我们将以我们现有的研究基础设施为基础务实的临床试验与5个大型卫生系统建立合作，以进行EPCT以改进高血压成年人的血压控制。我们将准备以患者为中心的准备就绪改善血压控制并测试认知能力下降和痴呆的过程。在实施阶段（R33）我们将进行一项随机务实的临床试验，以确定影响与通常的护理相比，基于临床决策支持和基于团队的BP管理关于认知障碍和痴呆症。我们将评估降低BP的好处和危害对生活质量和以患者为中心的结果的影响。从我们团队进行的持续工作中学到的现有研究基础设施和经验教训各种卫生系统的务实试验，为种族和社会经济多样的患者提供服务当前研究的基础。该试验是务实的，患者告知了基于证据的干预措施并在卫生系统的临床团队中使用信息技术交付工具。结果与包括患者，家庭，临床医生和健康在内的主要利益相关者有关系统。从该试验中学到的经验教训应推广到其他健康环境，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