Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations

项目总结 最近，收缩压干预试验(Sprint)报告称，更密集的血压 (BP)治疗(目标收缩压120毫米汞柱)将主要心血管疾病(CVD)减少约25% 与标准血压治疗(目标收缩压140毫米汞柱)相比，全因死亡率降低约27%。 在≥年龄50岁且有心血管疾病高危的高血压患者中。斯普林特清楚地回答了这个问题 -将血压降低到比目前推荐的目标更低的水平是否会进一步降低心血管疾病和死亡率的风险？ 下一个重要的问题是如何在现实世界的临床中实施更密集的BP治疗计划 这种做法，特别是在健康差距较大的人群中。传统上，服务不足的人群受益 更少的来自临床研究，这导致了美国的健康差距。我们建议进行一项 有效性-实施同时测试多组分有效性的混合试验 对更密集的BP治疗进行干预，以及实施 路易斯安那州对服务不足的高血压和心血管疾病高危患者的干预。合并后的 已经使用执行研究框架来指导多组成部分的开发 干预，包括使用Sprint分级护理强化BP管理的基于方案的治疗 算法，在患者、提供商团队和管理员、团队中传播Sprint研究结果- 基于协作护理、BP审核和反馈、家庭BP监测以及BP药物健康指导 坚持和改变生活方式。我们将与30家获得联邦资格的医疗中心诊所合作 为路易斯安那州东南部的低收入人口提供服务，以进行拟议的试验。初级临床 结果是两种干预措施中收缩压为120毫米汞柱的患者所占比例的差异 对照组为18个月龄。次要结果是收缩压平均变化的差异 和舒张压从基线到18个月的不良反应，以及生活质量。干预的忠诚度， 通过提供者团队的强化治疗(滴定或添加新药)和 在患者中坚持用药，将是主要实施成果。拟议的审判，有一个 30家诊所(38名患者/诊所)的样本大小，具有90%的统计能力来检测15%的增长 在双侧显著水平的患者中，收缩压为120毫米汞柱(主要临床结果)的患者所占比例 0.05。0.049的组内相关性与强化血压控制(收缩压)患者的比例 控制组为25%(&lt；120 mm Hg)的假设是基于以前的经验。我们将招募1350人 患者(45名患者/诊所)，以弥补由于潜在的退出而失去的统计能力。这项研究非常有意义。 及时，并具有重要的公共卫生和临床影响。它将在以下方面生成急需的数据 有效、可采用和可持续的干预战略，旨在消除健康差距和 减少美国少数民族和低收入人群中与BP相关的疾病负担。

PROJECT SUMMARY Recently, the Systolic Blood Pressure Intervention Trial (SPRINT) reported that more intensive blood pressure (BP) treatment (target systolic BP<120 mmHg) reduced major cardiovascular disease (CVD) by about 25% and all-cause mortality by about 27% compared to standard BP treatment (target systolic BP<140 mmHg) among hypertensive patients aged ≥50 years and at high risk for CVD. SPRINT clearly answered the question – Will lowering BP more than the currently recommended goal further reduce the risk of CVD and mortality? The next important question is how to implement a more intensive BP treatment program in real-world clinical practice, especially in populations with health disparities. Traditionally, underserved populations have benefited less from clinical research, which contributes to health disparities in the US. We propose to conduct an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multicomponent intervention for more intensive BP treatment and the feasibility, fidelity, and sustainability of implementing the intervention in underserved patients with hypertension and at high risk for CVD in Louisiana. The Consolidated Framework for Implementation Research has been used to guide the development of the multicomponent intervention, including protocol-based treatment using the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT study findings among patients, provider-teams, and administrators, team- based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on BP medication adherence and lifestyle modification. We will collaborate with 30 Federally Qualified Health Center clinics that serve low-income populations in southeast Louisiana to conduct the proposed trial. The primary clinical outcome is the difference in the proportion of patients with systolic BP <120 mmHg between the intervention and control groups at 18 months. The secondary outcomes are the differences in mean changes of systolic and diastolic BP from baseline to 18 months, adverse effects, and quality of life. The fidelity of the intervention, measured by intensification of treatment (titration or addition of new medication) by provider-teams and adherence to medications in patients, will be the primary implementation outcome. The proposed trial, with a sample size of 30 clinics (38 patients/clinic), has 90% statistical power to detect a 15% increase in the proportion of patients with systolic BP<120 mmHg (primary clinical outcome) at a 2-sided significance level of 0.05. An intra-cluster correlation of 0.049 and a proportion of patients with intensive BP control (systolic BP <120 mmHg) of 25% in the control group are assumed based on previous experience. We will recruit 1,350 patients (45 patients/clinic) to make up for lost statistical power due to potential withdrawal. This study is very timely and has important public health and clinical implications. It will generate urgently needed data on effective, adoptable, and sustainable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in ethnic minority and low-income populations in the US.