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.

阿根廷每年 30% 的死亡是由心血管疾病 (CVD) 造成的，来自高收入群体的证据 各国表明，通过有效筛查、治疗和控制危险因素，可以将这种情况减少一半。 尽管政府提供全民健康覆盖、免费医疗服务和基本药物， 低于 30% 的符合条件的患者参加免费慢性病药物计划，低于 10% 发起一年后仍在参与。有效性证据存在差距 在全面且具有成本效益的实施战略领域采取行之有效的干预措施， 多个利益相关者和干预措施，包括意识、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) 可以改善筛查 并使用经过验证的移动医疗筛查工具和电子调度应用程序与护理联系起来，但它没有 导致改善处方或服药依从性。我们建议评估是否将所有步骤链接起来 连续护理将通过改善风险因素控制来降低绝对 CVD 风险。为了填补 循证护理的三大差距 我们将通过以下方式评估实施效果 具体目标：（1）使用系统级框架来调整和评估我们的多级干预 重点关注系统结构、反馈循环和关键结构要素。我们将调动所有关键 参与在国家、省、诊所提供初级保健卫生服务的利益攸关方 和社区层面的形成性评估。综合实施框架 研究将在整群随机对照试验中确定干预实施之前的适应性 （RCT）并在试验开始后促进针对具体情况的适应。 (2) 评估 连接 CVD 护理关键方面的多成分策略的有效性和成本 连续体，在一项跨越三个省份的两个臂的随机对照试验中。主要结果是平均差 10 年 CVD 绝对风险。我们将比较通常的纸质指南与干预措施，这是一个 全球数据管理系统连接社区卫生工作者的数字移动健康筛查工具、电子预约 日程安排、血脂即时检测 (POCT)、药物启动的临床决策支持以及 短信提醒系统，用于遵守药物治疗和改变生活方式。 (3) 评估水平 移动医疗工具的扩展、干预措施的可持续性和覆盖范围。 RCT 后， 将使用 REAIM 评估干预措施的横向规模和长期可持续性 框架。我们还将使用哈佛 CVD 评估干预措施的成本效益 针对阿根廷校准的预测模型。定性（形成性评价）和定量相结合 （随机对照试验），这些结果将提供对干预措施实施情况的全面了解。全部 调查结果将通过与主要利益攸关方举行的一系列会议、同行出版物来传播 审阅期刊和重要科学会议。