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（目标收缩压<120 mm Hg）可减少轻度认知障碍的发生以及MCI和痴呆的合并结局。由于对潜在危害的担忧，专家和专业协会对BP目标的看法仍然存在分歧。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）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-Pieces (NCT02587936)，作为NIH卫生保健系统研究合作实验室示范项目的一部分，这是在慢性肾病、高血压和糖尿病共存的慢性疾病患者中最大的ePCT。我们现在建议通过降低血压目标试验（PCOT）来预防认知能力下降，以检查将血压降至130/80以下对认知能力下降的影响。我们的主要假设是，与接受常规医疗护理的患者相比，接受协作模式的患者将临床决策支持应用于家庭bp和初级保健实践中的团队护理相结合，可以更好地控制血压，降低轻度认知障碍和痴呆的发病率。