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: 10450252
• 负责人: Jiang He
• 金额: $ 131.03万
• 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/10450252
• 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 intervention; blood pressure reduction; blood pressure regulation; 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; implementation outcomes; implementation strategy; implementation trial; improved; 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担着痴呆症的负担不成比例的负担，在认知障碍的试验中的代表性不足。收缩压干预试验（SPRINT）表明，与标准的BP干预相比，强化血压（BP）干预（目标收缩压<120 mmHg）降低了认知障碍的风险（收缩BP靶标<140 mmHg）。下一个重要的步骤是确定如何在现实世界中的诊所环境中实施成功的Sprint强化干预措施，以防止认知能力下降。拟议的研究的总体目的是测试一种多方面的策略，用于实施重密集的BP干预方案，该协议适用于针对收缩期BP <120 mmHg的冲刺量，用于在路易斯安那州和密西西比州的种族少数群体和低收入高血压高血压患者的认知下降中的认知能力下降。 Re-Aim（达到有效性采用实施维护）已用于指导多方面实施策略的开发和评估，包括基于协议的治疗方法，采用Sprint踏入Sprint阶梯式强化BP管理算法，传播SPRINT发现，共享 - 决策制定，基于团队决策的协作，BP审计，BP审计，BP审计和反馈和反馈，监控，并进行了患者的病人，并进行了病人的护理，并进行了病人的培训，并进行了健康培训。在正在进行的以患者为中心的以患者为中心的治疗策略（Infcepts-BP）试验的基础上，我们将在36个联邦合格的健康中心诊所中进行成本效益进行集群随机试验，这些试验服务于路易斯安那州和密西西比州的低收入人群。拟议试验的主要结果是在干预措施和增强的常规护理组之间平均42个月内，全球认知综合Z分数平均变化的净差异。次要结果包括执行功能的平均变化和记忆复合Z得分，收缩压和舒张压，不利影响以及生活质量的净差异。也将收集实施结果，包括可接受性，适应性，采用，可行性，忠诚度，外观和成本效益，并用于改善试验期间的干预措施。该试验的样本量为36个诊所（35例患者/诊所）具有85％的统计能力，可检测全球认知复合Z分数的0.30或更高的差异，其2侧显着性水平为0.05，假设随访损失为20％，并且群集内相关性为0.05。在对5项临床试验的荟萃分析中，全球认知复合Z分数的合并效应大小为0.35（95％CI 0.32，0.38）。这项研究将迫切需要有关有效，可采用和公平干预策略的数据，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。如果被证明有效，则可以在各种初级保健环境中进行调整和缩放强化血压降压的实施策略，以防止认知能力下降和临床痴呆。