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: 10467065
• 负责人: Jiang He
• 金额: $ 129.57万
• 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 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10467065
• 关键词: Adopted; Adoption; Adult; Adverse effects; African American; Age-Years; Algorithms; Blood Pressure; Clinic; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Cluster randomized trial; Cognitive; Consent Forms; 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; Institutional Review Boards; Intensive Care; Intervention; Intervention Studies; Intervention Trial; Interview; Journals; Louisiana; Low Income Population; Low income; Memory; Meta-Analysis; Minority; Minority Groups; Mississippi; Outcome; Outcome Measure; Outcome Study; Participant; Patients; Penetrance; Phase; Primary Health Care; Protocols documentation; Public Health; Published Comment; Quality of life; Reach Effectiveness Adoption Implementation and Maintenance; Research Design; Resources; Review Committee; Risk; Rural Population; Sample Size; Sampling; Side; Surveys; Testing; Time; Ursidae Family; adjudicate; aged; base; blood pressure control; blood pressure intervention; blood pressure reduction; cognitive function; cognitive testing; collaborative care; control trial; cost; cost effectiveness; design; effectiveness implementation study; effectiveness outcome; effectiveness testing; executive function; follow-up; hypertension control; hypertensive; implementation evaluation; implementation outcomes; implementation strategy; implementation trial; improved; intervention delivery; mild cognitive impairment; multi-component intervention; patient oriented; prevent; primary care setting; primary outcome; public health relevance; racial minority; recruit; retention rate; scale up; secondary outcome; shared decision making; staff intervention; treatment as usual; treatment strategy

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.

非裔美国人和低收入人群承受着不成比例的痴呆症负担，在认知障碍试验中代表性不足。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（目标收缩压<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成功实施SPRINT强化血压干预，以防止认知能力下降。本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，测试一种多层面策略，用于实施一种强化的血压干预方案，该方案采用SPRINT，目标是收缩压<120 mmHg，以治疗少数种族和低收入高血压患者的认知能力下降。RE-AIM（达到有效性采用实施维护）框架已被用于指导多方面实施策略的制定和评估，包括采用SPRINT分步护理强化血压管理算法的基于协议的治疗、SPRINT结果的传播、共享决策、基于团队的协作护理、血压审计和反馈、家庭血压监测和患者健康指导。基于正在实施的以患者为中心的多层面强化血压控制治疗策略（impact - bp）试验，我们将在路易斯安那州和密西西比州的36家联邦合格医疗中心诊所进行成本有效的集群随机试验，这些诊所为低收入人群提供服务。该试验的主要结果是干预组和强化常规护理组之间平均42个月的总体认知复合z评分平均变化的净差异。次要结局包括执行功能和记忆复合z分数的平均变化、收缩压和舒张压、不良反应和生活质量的净差异。还将收集实施结果，包括可接受性、适应性、采用、可行性、保真度、外显性和成本效益，并用于改善试验期间的干预措施交付。拟议的试验样本量为36个诊所（35例患者/诊所），在假设随访损失20%和聚类内相关性0.05的双侧显著性水平下，有85%的统计能力检测到全球认知复合z得分0.30或更高的差异。在5项临床试验的荟萃分析中，全球认知复合z-score的合并效应值为0.35 （95% CI 0.32, 0.38）。这项研究将产生迫切需要的有效、可采用和公平的干预策略的数据，以减少低收入和少数民族人群与血压相关的认知能力下降。如果证明有效，可以在不同的初级保健机构中调整和扩大强化降压的实施战略，以预防认知能力下降和临床痴呆。