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）每年导致阿根廷30%的死亡，高收入国家的证据表明， 许多国家的研究表明，通过有效的筛查、治疗和控制风险因素，这一比例可以降低一半。 尽管政府提供全民医疗保险、免费医疗服务和基本药物， 只有不到30%的符合条件的患者参加了免费慢性病药物治疗计划， 在开始一年后仍在参与。有效性的证据存在差距， 在全面和具有成本效益的执行战略领域采取行之有效的干预措施， 多个利益攸关方，以及包括认识，治疗， 和控制级联。在以前的工作中，我们发现社区卫生工作者（CHW）可以改善筛查 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护理联系起来，但它没有 从而改善处方或药物依从性。我们建议评估是否将 持续护理将通过改善危险因素控制来降低心血管疾病的绝对风险。为了填补 循证护理的三大差距我们将通过以下方面评估实施效果 具体目标：（1）使用系统级框架来调整和评估我们的多层次干预 重点研究系统结构、反馈回路和关键结构要素。我们会动用所有的 参与在国家、省、诊所提供初级保健服务的利益攸关方， 和社区层面的评估。全面实施框架 研究将在整群随机对照试验中确定干预实施前的适应措施 (RCT)并在审判开始后根据具体情况进行调整。(2)评估 将CVD护理的关键方面联系起来的多组分战略的有效性和成本 在一个RCT中，两个武器跨越三个省。主要结果是平均差异， 10年CVD风险我们将比较通常的，基于纸张的指导方针的干预，这是一个 全球数据管理系统，为社区卫生工作者连接数字移动健康筛查工具，电子预约 时间表，脂质的护理点测试（POCT），药物启动的临床决策支持，以及 短信提醒系统，用于坚持服药和改变生活方式。(3)评估水平 移动健康工具的规模、可持续性和干预措施的覆盖面。在RCT之后， 将使用REAIM评估干预措施的横向扩展和长期可持续性 框架.我们还将使用哈佛CVD评估干预的成本效益 预测模型校准到阿根廷。定性（形成性评价）与定量相结合 (RCT)，这些结果将提供对干预措施实施情况的全面了解。所有 将通过与主要利益攸关方举行一系列会议、在同行中出版物、 评论期刊和重要科学会议。