Implementing a Multicomponent Intervention to Improve Hypertension Control in Central America

项目摘要 尽管高血压的防治研究取得了进展，但其患病率仍很高，而且还在上升， 虽然高血压患者意识到、接受治疗和控制的比例很低，特别是在低收入人群中。 和中等收入国家(LMIC)。我们建议：评估以下方面的需求、障碍和知识差距 中美洲4个地区国家卫生保健系统中的高血压控制方案 4：危地马拉、洪都拉斯、萨尔瓦多和尼加拉瓜)；进行整群随机试验，以测试 危地马拉多层次、多成分血压控制干预方案研究 以及评估实施 方案在CA-4地区的初级卫生保健系统。我们将进行形成性研究，以评估 全系统干预计划的需要，BP控制战略的障碍和促进者，以及 在CA-4卫生保健系统中改善高血压控制的实施方面的知识差距。 拟议的试验将从32个初级保健地区招募1,770名研究参与者(55名患者年龄22岁≥ 高血压未得到控制的年份/地区)在由 危地马拉卫生部。16个卫生区将被分配到一个为期18个月的多组成部分 干预，包括基于方案的治疗，使用：标准血压(BP)管理 算法、基于团队的协作护理、BP审核和反馈、家庭BP监控和健康指导 坚持服用降压药和改变生活方式，16人接受常规护理。这项研究将使用 用于检验多成分干预有效性的有效性-实施混合类型2设计 程序。BP和其他指标将在基线、6个月、12个月和18个月测量。 临床结果是血压受控患者的比例(&lt；140/90 mm Hg)与 18个月时干预组和对照组。次要结果是收缩压和舒张压的净变化。 BP从基线降至18个月。执行结果(可接受性、采纳性、适当性、可行性、 保真度、覆盖范围和可持续性)将每6个月进行一次评估。RE-AIM框架将指导 制定、实施和评估干预措施，这将转化和调整 阿根廷的高血压控制计划已被证明是有效和可行的。我们已经集合好了 一个多学科调查小组，将与危地马拉的公共初级保健网络合作 进行这一实施研究项目。干预和研究结果是以患者为中心的， 患者、卫生保健提供者团队和其他利益相关者将参与计划的每一步 学习。我们会公布研究结果，并推广已证实有效的干预措施。 计划，这将产生关于有效、可采用和可持续干预的迫切需要的数据 旨在减少CA-4和其他低收入环境中与BP相关的疾病负担的战略。

Project Summary Despite advances in hypertension prevention and treatment research, its prevalence is high and increasing, while the proportions of hypertensive patients who are aware, treated, and controlled are low, especially in low- and middle-income countries (LMIC). We propose to: assess the needs, barriers, and knowledge gaps of hypertension control programs in the national health care systems of the Central America 4 region LMIC (CA- 4: Guatemala, Honduras, El Salvador, and Nicaragua); conduct a cluster randomized trial to test the effect of a multilevel and multicomponent intervention program on blood pressure (BP) control among Guatemalan hypertensive patients; and evaluate the adaptability, feasibility, fidelity, and sustainability of implementing the program in the primary health care systems of the CA-4 region. We will conduct formative research to assess the needs of system-wide intervention programs, barriers and facilitators of BP control strategies, and knowledge gaps about implementation for improving hypertension control in the CA-4 health care systems. The proposed trial will recruit 1,770 study participants from 32 primary care districts (55 patients aged ≥22 years with uncontrolled hypertension/district) within a subnational primary care network managed by the Guatemalan Ministry of Health. Sixteen health districts will be assigned to an 18-month multicomponent intervention, which includes protocol-based treatment using: a standard blood pressure (BP) management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification, and 16 to usual care. The study will use an effectiveness-implementation hybrid type 2 design to test effectiveness of the multicomponent intervention program. BP and other indicators will be measured at baseline and at months 6, 12, and 18. The primary clinical outcome is the difference in the proportion of patients with controlled BP (<140/90 mmHg) between the intervention and control groups at 18 months. The secondary outcome is net change in systolic and diastolic BP from baseline to 18 months. Implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, reach, and sustainability) will be measured every 6 months. The RE-AIM framework will guide the development, implementation, and assessment of the intervention, which will translate and adapt the Hypertension Control Program in Argentina that has been proven effective and feasible. We have assembled a multidisciplinary investigative team, which will collaborate with the public primary care network in Guatemala to conduct this implementation research project. The intervention and study outcomes are patient-centered, and patients, MOH provider-teams, and other stakeholders will be engaged at every step of the proposed study. We will disseminate the study findings and promote scale-up of the proven effective intervention program, which will generate urgently needed data on effective, adoptable, and sustainable intervention strategies aimed at reducing BP-related disease burden in CA-4 and other low-income settings.