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

• 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
• 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

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 <120 mm Hg）降低了轻度认知障碍的发生率， MCI和痴呆的结果。专家和专业团体对BP目标的意见分歧 由于对潜在危害的担忧，仍然存在。显然需要采取新的切实可行的办法 在临床实践中控制血压，并测试其有效性。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，研究实施证据的有效性- 在现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-片 （NCT 02587936），是慢性肾脏疾病慢性疾病共存患者中最大的ePCT， 高血压和糖尿病作为NIH卫生保健系统研究示范项目的一部分 合作实验室我们现在提出通过降低BP目标试验（PCOT）来预防认知能力下降， 研究将血压降至130/80以下对认知能力下降和痴呆发生率的影响。 我们的主要假设是，接受合作实验室模式治疗的患者， 在初级保健实践中提供的决策支持和基于团队的护理将有更好的血液 压力控制和轻度认知功能障碍和痴呆的发生率低于患者 接受常规的医疗护理。 在本建议书的规划阶段（R61），我们会在现有的研究基础设施上， 与5个大型卫生系统建立合作实验室，进行ePCT，以改善 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能力下降和痴呆症的过程。在 实施阶段（R33），我们将进行一项随机实用临床试验，以确定 与常规护理相比，初级护理实践中的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的研究我们将评估降低血压的益处和危害，以及 对生活质量和以患者为中心的结局的影响。 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经验教训 在为种族和社会经济多元化患者提供服务的多元化卫生系统中进行的务实试验提供了一个坚实的基础 为当前的研究奠定了基础。这项试验是务实的，以患者为基础的干预措施 并由卫生系统的临床团队利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相关，包括患者，家属，临床医生和健康 系统.从这项试验中吸取的教训应该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的最佳策略。 1