Implementing a Multicomponent Intervention to Improve Hypertension Control in Central America

项目摘要 尽管高血压预防和治疗研究取得了进展，但其患病率仍很高且不断增加， 而高血压患者知晓、治疗和控制的比例较低，尤其是低血压患者， 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LMIC（CA- 4：危地马拉、洪都拉斯、萨尔瓦多和尼加拉瓜）;进行一项群集随机试验， 一个多层次和多成分的干预计划，对血压（BP）控制危地马拉 高血压患者;并评估实施的适应性，可行性，保真度和可持续性， 在CA-4地区的初级卫生保健系统的计划。我们将进行形成性研究， 全系统干预计划的需求，BP控制策略的障碍和促进因素，以及 在CA-4卫生保健系统中改善高血压控制的实施方面存在知识差距。 拟定的试验将从32个初级保健区招募1，770名研究参与者（55名年龄≥22岁的患者 高血压控制不佳的年数/地区）， 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审计和反馈，家庭BP监测和健康指导 抗高血压药物治疗依从性和生活方式改变，16例为常规护理。本研究将使用 有效性-实施混合2型设计，用于测试多组分干预的有效性 程序.将在基线和第6、12和18个月测量血压和其他指标。主 临床结局是两组患者血压控制（<140/90 mmHg）的比例差异， 18个月时的干预组和对照组。次要结果是收缩压和舒张压的净变化 从基线至18个月的BP。实施结果（可接受性、采用性、适当性、可行性、 忠诚度、覆盖范围和可持续性）将每6个月进行一次衡量。RE-AIM框架将指导 干预措施的制定、实施和评估，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。我们已经组建 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 来进行这个实施研究项目。干预和研究结果以患者为中心， 患者，卫生部提供者团队和其他利益相关者将参与建议的每一步 study.我们会宣传研究结果，并推广已证实有效的干预措施 该计划将产生有效，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BP相关疾病负担的战略。

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.