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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：
10696234
负责人：
MIGUEL A VAZQUEZ
金额：
$ 123.81万
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 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10696234
关键词：
Acute Renal Failure with Renal Papillary Necrosis Age Years Cardiovascular system Caring Cessation of life Chronic Chronic Kidney Failure Clinical Cognitive Communities Dementia Development Diabetes Mellitus Drug Combinations Effectiveness Elderly Electrolytes Emergency department visit Enrollment Ethnic Origin Event Evidence based intervention Fracture Goals Guidelines Health system Healthcare Systems Home Home Blood Pressure Monitoring Hospitalization Hypertension Hypotension Impaired cognition Incidence Intervention Intervention Studies Intervention Trial Life Measures Medical Meta-Analysis Modeling Monitor Outcome Participant Patients Pharmaceutical Preparations Pharmacists Population Heterogeneity Pragmatic clinical trial Primary Care Professional Organizations Quality of life Randomized Research Sample Size Syncope Testing Titrations United States National Institutes of Health adjudication blood pressure control blood pressure reduction clinical decision support clinical practice cognitive testing collaboratory design effectiveness/implementation study evidence base falls future implementation global health hazard inclusion criteria insight instrument middle age mild cognitive impairment patient subsets pragmatic trial prevent primary care practice primary care setting primary outcome recruit research clinical testing secondary outcome socioeconomics systems research team-based care treatment as usual usual care arm

项目摘要

SPRINT, 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. Our main hypothesis is that patients who receive care with a collaboratory model that combines clinical decision support applied to home BPs 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 this ePCT (1) Will compare the effects of intensive BP control between the intervention and usual care arm on the rate of cognitive decline measuring the change in TICS-m per year. We will recruit 4,000 patients over 70 years of age with BP >130/80 mmHg from 2 diverse health systems and randomize patients within each health system to usual care or to a combination of care with clinical decision support using home BPs and practice facilitators and Pharm Ds to lower home BP to < 130/80 mmHg. The primary outcome will be development cognitive decline as determined by a decrease in TICS-m scores from baseline; (2) Determine the potential harms of intensive lowering BP home BP below 130/80 mmHg with usual care on hospitalizations, emergency department visits, cardiovascular events, deaths, syncope, falls, fractures, hypotension, electrolyte abnormalities and acute kidney injury and; (3) Determine the impact of intensive BP management on QOL with scores obtained using the PROMIS Scale v1.2 - Global Health instrument annually This trial is pragmatic, with broad inclusion criteria and evidence-based interventions informed by patients and delivered in primary care settings by the clinical teams in health systems serving ethnically and socioeconomically diverse population. Lessons from this trial should provide valuable insights to guide clinical practices in BP control and cognitive assessments in real-world settings as well as design and implementation of future pragmatic trials. 1

Sprint及其附带的以认知为重点的子研究Sprint-Mind最近表明，血压控制(Target SBP&lt；120 mm Hg)可以减少轻度认知障碍以及MCI和痴呆症的综合结果。由于对潜在危害的担忧，专家和专业团体对BP目标的看法仍存在分歧。显然有必要在临床实践中实施新的实用方法来控制血压，并测试其有效性。嵌入在卫生系统中的实用临床试验(EPCT)提供了一个独特的机会来研究在现实世界的临床环境中实施循证干预措施的有效性。我们的团队目前正在进行ICD-PICES(NCT02587936)，这是美国国立卫生研究院医疗保健系统研究合作实验室示范项目的一部分，是针对慢性肾脏疾病、高血压和糖尿病并存的慢性疾病患者的最大ePCT。我们现在提出通过降低血压目标试验(PCOT)来预防认知下降，以检查将血压降至130/80以下对认知下降发生率的影响。我们的主要假设是，与接受常规医疗护理的患者相比，接受合作模式的患者将获得更好的血压控制，并降低轻度认知障碍和痴呆症的发生率。合作模式结合了应用于家庭BPS的临床决策支持和在初级保健实践中提供的基于团队的护理。在这项研究中，ePCT(1)将比较干预组和常规护理组强化血压控制对认知功能减退率的影响，测量每年抽动障碍的变化。我们将从两个不同的医疗系统招募4,000名70岁以上的BP&GT；130/80毫米汞柱患者，并将每个医疗系统中的患者随机分配到常规护理或使用家庭BP和实践促进器和制药D将家庭BP降至&lt；130/80毫米汞柱的护理与临床决策支持的组合。主要结果将是发育认知能力下降，根据TICS-m评分从基线下降来确定；(2)通过住院、急诊科就诊、心血管事件、死亡、晕厥、跌倒、骨折、低血压、电解质异常和急性肾损伤等常规护理，确定强化血压管理对生活质量的潜在危害；(3)使用PROMIS量表V1.2-全球健康工具每年获得的评分来确定强化BP管理对生活质量的影响这项试验是务实的，采用广泛的纳入标准和循证干预措施，由患者知情，并由卫生系统中的临床团队在初级保健环境中提供，服务于种族和社会经济多样化的人口。这项试验的经验教训应该为指导临床实践中的BP控制和真实世界环境中的认知评估以及未来实用试验的设计和实施提供有价值的见解。 1