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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 及其伴随的以认知为中心的子研究 SPRINT-MIND 最近表明，血压控制（目标 SBP<120 mm Hg）可减少轻度认知障碍以及 MCI 和痴呆的综合结果。由于担心潜在危害，专家和专业协会对 BP 目标的意见分歧仍然存在。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)，这是对慢性肾病、高血压和糖尿病共存的慢性病患者进行的最大的 ePCT，作为 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血压目标试验（PCOT）来预防认知能力下降，以检查将血压降低至 130/80 以下对认知能力下降发生率的影响。我们的主要假设是，与接受常规医疗护理的患者相比，接受协作模型护理的患者将获得更好的血压控制，轻度认知障碍和痴呆症的发生率更低，该协作模型结合了应用于家庭血压的临床决策支持和初级护理实践中提供的基于团队的护理。在此 ePCT 中 (1) 将比较干预组和常规护理组之间的强化血压控制对认知下降率的影响，测量每年 TICS-m 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到常规护理或使用家庭血压、实践辅导员和药学博士进行护理与临床决策支持相结合，以将家庭血压降低至 < 130/80 mmHg。主要结局是发育认知能力下降，由 TICS-m 评分较基线下降确定； (2) 确定在常规护理下强化降压家庭血压低于 130/80 mmHg 对住院、急诊就诊、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的潜在危害； (3) 每年使用 PROMIS 量表 v1.2 - 全球健康工具获得的分数确定强化血压管理对生活质量的影响这项试验是务实的，具有广泛的纳入标准和基于证据的干预措施，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中的临床团队在初级保健机构中提供。该试验的经验教训应提供有价值的见解，以指导现实世界中血压控制和认知评估的临床实践以及未来实用试验的设计和实施。 1