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 非裔美国人和低收入人群承担着痴呆症的负担不成比例的负担 认知障碍试验中的代表性不足。收缩压干预试验（SPRINT） 表明强化血压（BP）干预（靶标收缩BP <120 mmHg）降低了 与标准BP干预（收缩BP靶标<140 mmHg）相比，认知障碍。下一个 重要的步骤是确定如何成功的冲刺强化血压干预如何 在现实世界中实施，以防止认知能力下降。提议的总体目标 研究是为了测试一种多面策略，用于实施由重密度BP干预协议改编而成的 Sprint靶向收缩BP <120 mmHg的少数族裔和低收入性高血压的认知能力下降 路易斯安那州和密西西比州资源受限的初级保健实践的患者。 re-aim（触及 有效性采用实施维护）框架已用于指导开发和 评估多方面实施策略，包括采用基于协议的治疗 Sprint步进护理密集的BP管理算法，Sprint发现的传播，共享 - 决策，基于团队的协作护理，BP审核和反馈，家庭BP监控以及患者 健康教练。建立持续实施以患者为中心的治疗 强化血压控制（影响）试验的策略，我们将成本开展群集 - 在路易斯安那州为低收入人群服务的36个联邦资格卫生中心诊所的随机试验 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 在干预和增强的常规护理之间从基线到42个月的认知复合Z得分 组。次要结果包括执行功能和内存的平均变化的净差异 复合Z得分，收缩期和舒张压，不利影响以及生活质量。实施结果， 包括可接受性，适应，采用，可行性，忠诚，外观，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。提议 试验，样本量为36个诊所（35例患者/诊所），具有85％的统计能力，可检测0.30或更高 假设损失20％ 随访和群内相关性为0.05。在5项临床试验的荟萃分析中，汇总效应大小 对于全球认知复合Z分数，为0.35（95％CI 0.32，0.38）。这项研究将紧急产生 有关有效，可采用和公平干预策略的必要数据，以减少血压相关 低收入和少数民族人口的认知能力下降。如果被证明有效，则实施策略 可以在各种初级保健环境中调整强化血压降压，以防止 认知能力下降和临床痴呆。