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.

项目总结/摘要 非裔美国人和低收入人群承担着不成比例的痴呆症负担， 在认知障碍的试验中代表性不足。收缩压干预试验（SPRINT） 显示，强化血压（BP）干预（目标收缩压<120 mmHg）降低了 与标准BP干预（收缩压目标<140 mmHg）相比，认知障碍。下一 重要的一步是确定如何成功的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 这项研究是为了测试一种多方面的策略，用于实施一种适应于 SPRINT靶向收缩压<120 mmHg对少数民族和低收入高血压患者认知功能下降的影响 路易斯安那州和密西西比州资源有限的初级保健实践中的患者。RE-AIM（Reach） 有效性、采用和实施（维持）框架已被用于指导 评价多方面的实施策略，包括采用 SPRINT阶梯式护理强化BP管理算法，SPRINT结果的传播，共享- 决策制定、基于团队的协作护理、BP审计和反馈、家庭BP监测和患者 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（IMPACT）试验，我们将以具有成本效益的方式开展一项集群- 在路易斯安那州为低收入人群提供服务的36家联邦合格健康中心诊所中进行的随机试验 和密西西比。拟议试验的主要结局是总体平均变化的净差异 从基线到干预和强化常规护理之间42个月的认知复合z评分 组次要结果包括执行功能和记忆平均变化的净差异 复合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、适应性、采用性、可行性、忠实性、可接受性、成本效益和 可持续性，也将收集和使用，以改善在试验期间的干预交付。拟议 一项样本量为36家诊所（35例患者/诊所）的试验具有85%的统计把握度，可检测出0.30或更高的 假设损失20%，双侧显著性水平为0.05时总体认知复合z评分的差异 组内相关系数为0.05。在5项临床试验的荟萃分析中， 总体认知综合z评分为0.35（95% CI 0.32，0.38）。这项研究将产生迫切 需要关于有效、可采用和公平的干预策略的数据，以减少与血压相关的 低收入和少数民族人群的认知能力下降。如果证明有效， 在不同的初级保健环境中，可以调整和扩大强化降压， 认知能力下降和临床痴呆。