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: 10452795
• 负责人: MIGUEL A VAZQUEZ
• 金额: $ 124.19万
• 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 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10452795
• 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; Event; Evidence based intervention; Fracture; Future; Goals; Guidelines; Health system; Healthcare Systems; Home; Home Blood Pressure Monitoring; Hospitalization; Hypertension; Hypotension; Impaired cognition; Incidence; Intervention; Intervention Trial; Measures; Medical; Meta-Analysis; Modeling; Monitor; Outcome; Participant; Patients; Pharmaceutical Preparations; Pharmacists; Population Heterogeneity; Pragmatic clinical trial; Primary Health Care; Professional Organizations; Quality of life; Randomized; Sample Size; Syncope; Testing; Titrations; United States National Institutes of Health; adjudication; base; blood pressure reduction; blood pressure regulation; clinical decision support; clinical practice; cognitive development; cognitive testing; collaboratory; design; effectiveness implementation study; evidence base; falls; global health; hazard; inclusion criteria; insight; instrument; mild cognitive impairment; patient subsets; pragmatic trial; prevent; primary care setting; primary outcome; recruit; research clinical testing; secondary outcome; socioeconomics; systems research; treatment as usual; usual care arm

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及其伴随的以认知为重点的子研究SPRINT-MIND最近表明，血压控制（目标SBP<120 mm Hg）减少了轻度认知障碍事件以及MCI和痴呆的综合结局。由于担心潜在的危害，专家和专业团体对BP目标的意见仍然存在分歧。显然需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。嵌入卫生系统的实用临床试验（ePCT）为研究在现实世界临床环境中实施循证干预措施的有效性提供了独特的机会。我们的团队目前正在进行ICD-碎片（NCT 02587936），这是慢性肾病、高血压和糖尿病并存慢性疾病患者中最大的ePCT，是NIH医疗保健系统研究合作实验室示范项目的一部分。我们现在提出通过降低BP目标试验（PCOT）预防认知下降，以检查将BP降低到低于130/80对认知下降发生率的影响。我们的主要假设是，接受护理的患者与合作实验室模式相结合，临床决策支持应用于家庭BP和团队为基础的护理提供初级保健的做法将有更好的血压控制和轻度认知障碍和痴呆症的发病率较低的患者接受常规的医疗护理。 在本ePCT（1）中，将比较干预组和常规护理组之间强化BP控制对认知下降率的影响，测量TICS-m每年的变化。我们将从2个不同的卫生系统招募4，000名70岁以上血压>130/80 mmHg的患者，并将每个卫生系统内的患者随机分配至常规护理或护理与临床决策支持的组合，使用家庭BP和实践促进者和Pharm Ds将家庭BP降低至< 130/80 mmHg。（2）确定在住院、急诊科就诊、心血管事件、死亡、晕厥、福尔斯、骨折、低血压、电解质异常和急性肾损伤时，通过常规护理将家庭BP强化降低至130/80 mmHg以下的潜在危害;（3）每年使用PROMIS量表v1.2 -全球健康工具获得评分，确定强化BP管理对QOL的影响 这项试验是务实的，具有广泛的入选标准和循证干预措施，由患者告知，并由服务于种族和社会经济多样化人群的卫生系统的临床团队在初级保健环境中提供。这项试验的经验教训应该提供有价值的见解，指导临床实践中的BP控制和认知评估在现实世界中的设置，以及设计和实施未来的务实试验。 1