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.

项目概要/摘要 非裔美国人和低收入人群承受着不成比例的痴呆症负担，并且 在认知障碍试验中代表性不足。收缩压干预试验 (SPRINT) 研究表明，强化血压 (BP) 干预（目标收缩压 <120 mmHg）可降低以下风险： 与标准血压干预（收缩压目标<140 mmHg）相比的认知障碍。下一个 重要的一步是确定如何成功进行 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。拟议的总体目标 研究的目的是测试实施强化血压干预方案的多方面策略，该方案改编自 SPRINT 的目标是收缩压 <120 mmHg，以应对少数族裔和低收入高血压患者的认知能力下降 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。重新瞄准（达到 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估，包括采用以下方法的基于方案的治疗： SPRINT 分级护理强化血压管理算法、传播 SPRINT 研究结果、共享 决策、基于团队的协作护理、血压审核和反馈、家庭血压监测以及患者 健康辅导。以持续实施以患者为中心的多方面治疗为基础 强化血压控制策略（IMPACTS）试验，我们将经济高效地进行集群- 在路易斯安那州 36 个为低收入人群提供服务的联邦合格健康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 干预和强化常规护理之间从基线到 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力平均变化的净差异 综合 z 评分、收缩压和舒张压、不良反应和生活质量。实施成果， 包括可接受性、适应性、采用性、可行性、保真度、渗透率、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措施。拟议的 该试验的样本量为 36 个诊所（35 名患者/诊所），具有 85% 的统计功效来检测 0.30 或更高 假设损失 20%，双边显着性水平为 0.05 时全局认知综合 z 得分的差异 进行随访，簇内相关性为 0.05。在 5 项临床试验的荟萃分析中，汇总效应大小 整体认知综合 z 得分为 0.35（95% CI 0.32，0.38）。这项研究将紧急产生 需要有关有效、可采用和公平的干预策略的数据，以降低与血压相关的风险 低收入和少数民族人口的认知能力下降。如果证明有效，实施策略 强化降压可以在不同的初级保健机构中进行调整和扩大，以预防 认知能力下降和临床痴呆。