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

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的代表性不足。收缩压干预试验（SPRINT）显示，与标准血压干预（收缩压目标<140 mmHg）相比，强化血压（BP）干预（收缩压目标<120 mmHg）降低了认知障碍的风险。下一个重要的步骤是确定如何在现实世界的临床环境中实施成功的SPRINT强化血压干预，以防止认知能力下降。拟议研究的总体目标是在路易斯安那州和密西西比州资源有限的初级保健实践中，测试实施强化BP干预方案的多方面策略，该方案改编自SPRINT，目标是收缩压<120 mmHg，用于治疗少数民族和低收入高血压患者的认知下降。RE-AIM（达到有效性采用实施维护）框架已用于指导多方面实施策略的开发和评价，包括采用SPRINT阶梯式护理强化BP管理算法的基于方案的治疗、SPRINT结果的传播、共享决策、基于团队的协作护理、BP审计和反馈、家庭BP监测和患者健康指导。在正在进行的实施多方面以患者为中心的治疗策略强化血压控制（IMPACTS-BP）试验的基础上，我们将在路易斯安那州和密西西比州为低收入人群服务的36家联邦合格健康中心诊所进行一项具有成本效益的群集随机试验。拟议试验的主要结局是干预组和加强常规护理组之间平均42个月的总体认知综合z评分平均变化的净差异。次要结果包括执行功能和记忆复合z评分、收缩压和舒张压、不良反应和生活质量的平均变化的净差异。还将收集实施结果，包括可接受性、适应性、采用性、可行性、保真度、可接受性和成本效益，并用于在试验期间改善干预措施的实施。拟定试验的样本量为36家诊所（35例患者/诊所），假设20%失访和群内相关性为0.05，在双侧显著性水平为0.05时，有85%的统计把握度检测到总体认知复合z评分的差异为0.30或更高。在5项临床试验的荟萃分析中，总体认知复合z评分的汇总效应量为0.35（95% CI 0.32，0.38）。这项研究将产生迫切需要的数据，说明有效、可采用和公平的干预策略，以减少低收入和少数族裔人群中与血压相关的认知能力下降。如果证明有效，强化降压的实施策略可以在不同的初级保健环境中进行调整和扩大，以预防认知能力下降和临床痴呆。

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-BP) 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 over an average of 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, and cost-effectiveness, 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.