Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-income and Minority Hypertensive Patients

实施强化降压干预措施对低收入和少数民族高血压患者认知功能下降的有效性

• 批准号: 10045826
• 负责人: Jiang He
• 金额: $ 76.81万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045826
• 关键词: Adopted; Adoption; Adult; Adverse effects; African American; Age-Years; Algorithms; Authorization documentation; Blood Pressure; Clinic; Clinical; Clinical Trials; Cluster randomized trial; Cognitive; Data; Data Collection; Dementia; Development; Diastolic blood pressure; Effectiveness; Electronic Health Record; Enrollment; Ensure; Evaluation; Federally Qualified Health Center; Feedback; Global Change; Health; Home Blood Pressure Monitoring; Hypertension; Impaired cognition; Intensive Care; Intervention; Intervention Trial; Interview; Length; Louisiana; Low Income Population; Low income; Maintenance; Memory; Meta-Analysis; Minority; Mississippi; Outcome; Outcome Measure; Outcome Study; Participant; Patients; Penetrance; Phase; Population; Primary Health Care; Protocols documentation; Public Health; Published Comment; Quality of life; Research Design; Resources; Review Committee; Risk; Sales; Sample Size; Sampling; Side; Surveys; Testing; Time; Ursidae Family; adjudicate; base; blood pressure intervention; blood pressure reduction; blood pressure regulation; cognitive change; cognitive function; cognitive testing; collaborative care; cost; cost effectiveness; effectiveness implementation study; effectiveness testing; executive function; follow-up; health disparity; human old age (65+); hypertension control; implementation strategy; implementation trial; improved; mild cognitive impairment; multi-component intervention; patient oriented; prevent; primary care setting; primary outcome; racial minority; recruit; retention rate; scale up; secondary outcome; shared decision making; staff intervention; treatment as usual; treatment strategy

Project Summary/Abstract African American and low-income populations bear a disproportionate burden of dementia and have been underrepresented in trials of cognitive impairment. The Systolic Blood Pressure Intervention Trial (SPRINT) showed that an intensive blood pressure (BP) intervention (target systolic BP <120 mmHg) lowered the risk of cognitive impairment compared to a standard BP intervention (systolic BP target <140 mmHg). The next important step is to determine how the successful SPRINT intensive blood pressure intervention can be implemented in a real-world clinic setting to prevent cognitive decline. The overall objective of the proposed study is to test a multifaceted strategy for implementing an intensive BP intervention protocol adapted from SPRINT targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income hypertensive patients in resource-constrained primary care practices in Louisiana and Mississippi. The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework has been used to guide the development and evaluation of the multifaceted implementation strategy, including protocol-based treatment that employs the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT findings, shared- decision making, team-based collaborative care, BP audit and feedback, home BP monitoring, and patient health coaching. Building on the ongoing Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) trial, we will cost-effectively conduct a cluster- randomized trial in 36 Federally Qualified Health Center clinics that serve low-income populations in Louisiana and Mississippi. The primary outcome in the proposed trial is the net difference in mean change of global cognitive composite z-score from baseline to 42 months between the intervention and enhanced usual care groups. Secondary outcomes include net difference in mean change of executive function and memory composite z-scores, systolic and diastolic BP, adverse effects, and quality of life. Implementation outcomes, including acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness and sustainability, will also be collected and used to improve intervention delivery during the trial. The proposed trial, with a sample size of 36 clinics (35 patients/clinic), has 85% statistical power to detect a 0.30 or higher difference in the global cognitive composite z-score at a 2-sided significance level of 0.05 assuming 20% loss to follow-up and an intra-cluster correlation of 0.05. In a meta-analysis of 5 clinical trials, the pooled effect size was 0.35 (95% CI 0.32, 0.38) for the global cognitive composite z-score. This study will generate urgently needed data on effective, adoptable, and equitable intervention strategies to reduce blood pressure-related cognitive decline in low-income and minority populations. If proven effective, the implementation strategy for intensive blood pressure reduction could be adapted and scaled up in diverse primary care settings to prevent cognitive decline and clinical dementia.

项目摘要/摘要 非洲裔美国人和低收入人群背负着不成比例的痴呆症负担，一直以来 在认知障碍试验中的代表性不足。收缩压干预试验(Sprint) 结果显示，高强度的血压干预(目标收缩压120毫米汞柱)降低了患高血压的风险。 认知损害与标准血压干预(收缩压目标和140毫米汞柱)的比较。下一个 重要的一步是确定如何才能成功地进行Sprint强化血压干预 在现实世界的诊所环境中实施，以防止认知能力下降。建议的总体目标是 这项研究是为了测试实施强化BP干预方案的多方面策略，该方案改编自 Sprint靶向收缩压120毫米汞治疗少数民族和低收入高血压患者认知功能减退 路易斯安那州和密西西比州资源有限的初级保健机构的患者。RE-AIM(REACH 有效性采用实施维护)框架已用于指导开发和 对多方面实施战略的评价，包括采用基于方案的治疗 斯普林特分级护理重症BP管理算法，传播斯普林特研究结果，分享- 决策、基于团队的协作护理、BP审核和反馈、家庭BP监控和患者 健康教练。在持续实施以患者为中心的多方面治疗的基础上 强化血压控制策略(IMPACTS)试验，我们将以符合成本效益的方式进行一组- 在路易斯安那州为低收入人群提供服务的36家联邦合格卫生中心诊所进行的随机试验 和密西西比州。拟议试验的主要结果是全球平均变化的净差异 干预和加强日常护理之间从基线到42个月的认知综合z评分 组。次要结果包括执行功能和记忆的平均变化的净差异 综合Z评分、收缩压和舒张压、不良反应和生活质量。执行成果， 包括可接受性、适应、采用、可行性、保真度、外显性、成本效益和 可持续性，也将被收集并用于改善试验期间的干预交付。建议数 试验的样本大小为36家诊所(35名患者/诊所)，具有85%的统计能力来检测0.30或更高 假设损失20%，在双侧显着性水平0.05的情况下，全球认知综合z得分的差异 随访组内相关系数为0.05。在对5项临床试验进行的荟萃分析中，合并效应大小 全球认知综合z得分为0.35(95%可信区间0.32，0.38)。这项研究将迫切地产生 需要关于有效、可采用和公平的干预策略以降低血压相关的数据 低收入和少数群体中的认知衰退。如果被证明是有效的， 可以在不同的初级保健环境中调整和扩大强化降压措施，以防止 认知功能减退与临床痴呆。