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

PRIMECare 试验：通过移动医疗、电子决策支持和社区卫生工作者预防缺血性心脏病。

• 批准号: 10627833
• 负责人: THOMAS A GAZIANO
• 金额: $ 62.37万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627833
• 关键词: Adherence; Adult; Appointments and Schedules; Area; Argentina; Argentine; Awareness; Blood Pressure; Calibration; Cardiovascular Diseases; Caring; Cessation of life; Cholesterol; Chronic; Chronic Disease; Clinic; Clinical effectiveness; Collaborations; Communities; Community Health Aides; Complex; Continuity of Patient Care; Country; Data Management Resources; Diagnostic; Disparity; Dyslipidemias; Effectiveness; Effectiveness of Interventions; Electronics; Elements; Eligibility Determination; Evaluation; Federal Government; Feedback; Funding; Goals; Government; Grant; Guidelines; Health; Health Policy; Health Services; Health system; Healthcare; Hypertension; Income; Intervention; Journals; Life Style; Link; Lipids; Medicine; Methods; Myocardial Ischemia; Paper; Patient Participation; Peer Review; Pharmaceutical Preparations; Phase; Policies; Population; Premature Mortality; Provider; Province; Public Health; Publications; Randomized, Controlled Trials; Reminder Systems; Research; Research Personnel; Risk Factors; Schedule; Screening procedure; Series; Smoking; Structure; System; Underserved Population; Uninsured; United States National Institutes of Health; Universities; Work; arm; blood pressure reduction; cardiovascular disorder risk; clinical decision support; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; digital; effectiveness evaluation; evidence base; experience; formative assessment; hypertension control; implementation evaluation; implementation framework; implementation intervention; implementation strategy; implementation/effectiveness; improved; innovation; low and middle-income countries; mHealth; medication compliance; meetings; mortality; multi-component intervention; point of care testing; predictive modeling; prevent; primary care clinic; primary health service; primary outcome; programs; randomized, clinical trials; screening; screening guidelines; tobacco control; tool; treatment arm; treatment guidelines; usual care arm

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.

心血管疾病（CVD）每年在阿根廷造成30％的死亡和高收入的证据 各国表明，通过有效的筛查，治疗和对危险因素的控制，这可以减少一半。 尽管政府提供了普遍的健康覆盖范围，免费卫生服务和基本药物，但 不到30％的符合条件的患者参加了免费的慢性疾病药物计划，少于10％ 启动后一年仍在参加。存在差距在证据证明有效性的证据 在参与的全面且具有成本效益的实施策略领域进行了验证的干预措施 多个利益相关者以及包括关键步骤之间的链接的干预措施， 和控制级联。在先前的工作中，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筛选工具和电子调度应用程序与Care的联系，但没有 导致提高处方或依从性药物。我们建议评估是否将所有步骤链接在 护理连续体将通过改善风险因素控制来降低绝对CVD风险。为了填补 基于证据的护理中的三个主要差距我们将通过以下来评估实施效率 具体目的：（1）使用系统级框架适应和评估我们的多层次干预 专注于系统结构，反馈循环和关键结构元素。我们将参与所有钥匙 参与国家，省，诊所提供初级保健服务的利益相关者， 和社区层面的形成性评估。实施的综合框架 研究将在群集随机对照试验中进行干预之前确定适应 （RCT）并促进特定于上下文的适应，一旦试验开始。 （2）评估 链接CVD护理关键方面的多组分策略的有效性和成本 Continuum，在三个省份的RCT中，有两个武器。主要结果是平均差异 绝对10年CVD风险。我们将将通常的基于纸张的指南与干预进行比较，这是 全球数据管理系统链接CHW的数字MHealth筛选工具，电子约会 调度，护理点测试（POCT）脂质，药物启动的临床决策支持和 SMS提醒系统遵守药物和生活方式的变化。 （3）评估水平 扩展MHealth工具，可持续性和干预措施。在RCT之后， 将使用Reaim评估干预措施的水平缩放和长期可持续性 框架。我们还将使用哈佛CVD评估干预的成本效益 预测校准为阿根廷的模型。与定性（形成性评估）和定量结合 （RCT），这些结果将对干预的实施提供全面的理解。全部 调查结果将通过与主要利益相关者的一系列会议进行传播，同行的出版物 审查期刊和关键科学会议。