PRIMECare Trial: Preventing Ischemic Heart Disease with mHealth, electronic decision support, and Community Health Workers.

在阿根廷，心血管疾病(CVD)每年导致30%的死亡，来自高收入人群的证据 各国的情况表明，通过对风险因素进行有效的筛查、治疗和控制，可以将这一比例减少一半。 尽管政府提供全民医疗保险、免费医疗服务和基本药物， 不到30%的符合条件的患者参加了免费的慢性病药物治疗计划，不到10%的患者参加了免费慢性病药物治疗计划 在入会一年后仍在参与。在证据上存在差距，以证明 在全面和成本效益高的执行战略领域采取行之有效的干预措施 多个利益相关者，以及干预措施，包括在意识、治疗、 和控制级联。在之前的工作中，我们表明社区卫生工作者(CHW)改善了筛查 并使用经过验证的mHealth筛查工具和电子日程安排应用程序与医疗保健相关联，但它没有 改善处方或坚持服药。我们建议评估是否将 护理连续体将通过改善危险因素控制来降低心血管疾病的绝对风险。为了填满 循证护理中的三个主要差距我们将通过以下方式评估实施效果 具体目标：(1)使用系统级框架来适应和评估我们的多层次干预 重点关注系统结构、反馈回路和关键结构要素。我们会让所有的关键人物 利益攸关方参与在国家、省、诊所提供初级保健保健服务 和社区水平的形成性评估。实施的全面框架 研究将在干预实施之前在一项整群随机对照试验中确定适应性 (RCT)，并在试验开始后促进针对具体情况的适应。(2)评估 将心血管疾病护理的关键方面联系起来的多组分战略的有效性和成本 连续体，在三个省有两个武器的区域工作队。主要结果是平均差值 绝对的10年心血管疾病风险。我们将比较通常的纸质指南与干预，这是一种 全球数据管理系统链接CHW的数字mHealth筛查工具，电子预约 计划、血脂的护理点测试(POCT)、药物启动的临床决策支持，以及 坚持服药和生活方式改变的短信提醒系统。(3)横向考核 移动健康工具的可伸缩性、干预的可持续性和覆盖范围。在RCT之后， 将使用REAIM评估干预的横向规模和长期可持续性 框架。我们还将使用哈佛心血管疾病评估系统评估干预措施的成本效益。 预测模型已校准到阿根廷。定性(形成性评价)与定量相结合 (RCT)，这些结果将提供对干预实施情况的全面了解。全 调查结果将通过与主要利益攸关方的一系列会议、同行出版物-- 审阅期刊和重要的科学会议。

Cardiovascular disease (CVD) causes 30% of deaths annually in Argentina and the evidence from high-income countries shows that this can reduced by half through effective screening, treatment, and control of risk factors. Despite the government providing universal health coverage, free health services, and essential medicines, less than 30% of eligible patients participate in the free chronic disease medication program and less than 10% are still participating one year after initiation. Gaps exist in the evidence for the effectiveness of proven interventions in the areas of comprehensive and cost-effective implementation strategies that engage multiple stakeholders, and interventions that include links between keys steps in the awareness, treatment, and control cascade. In prior work, we showed that community health workers (CHWs) improve screening and linkage to care using a validated mHealth screening tool and electronic scheduling apps but it did not lead to improved prescription or adherence to medications. We propose assessing if linking all steps in the care continuum will reduce absolute CVD risk through improvement of risk factor control. In order to fill three major gaps in evidence-based care we will assess implementation effectiveness through the following specific aims: (1) Use a Systems Level Framework to adapt and evaluate our multi-level intervention focusing on system structure, feedback loops, and key structural elements. We will engage all key stakeholders involved in the provision of primary care health services at the national, provincial, clinic, and community levels in a formative evaluation. The Comprehensive Framework for Implementation Research will identify adaptations prior to intervention implementation in a cluster randomized control trial (RCT) and to facilitate context-specific adaptations once the trial commences. (2) Assess the effectiveness and costs of a multicomponent strategy linking key aspects of the CVD care continuum, in a RCT with two arms across three provinces. The primary outcome is mean difference in absolute 10-year CVD risk. We will compare usual, paper based guidelines to the intervention, which is a global data management system linking digital mHealth screening tool for CHWs, electronic appointment scheduling, point of care testing (POCT) for lipids, clinical decision support for medication initiation, and a SMS reminder system for adherence to medications and life-style changes. (3) Assess the horizontal scaling of the mHealth tool, the sustainability, and reach of the intervention. After the RCT, the horizontal scaling and long-term sustainability of the intervention will be assessed using the REAIM framework. We will also evaluate the cost-effectiveness of the intervention using the Harvard CVD PREDICT Model calibrated to Argentina. Combined with the qualitative (formative evaluation) and quantitative (RCT), these results will provide a comprehensive understanding of the implementation of the intervention. All findings will be disseminated through a series of meetings with key stakeholders, publications in peer- reviewed journals, and key scientific meetings.