Secondary Event Prevention using Population Risk Management After PCI

 描述(由申请人提供)： 背景：缺血性心脏病(IHD)是退伍军人发病率和死亡率的主要来源。IHD的最佳治疗需要使用药物，包括他汀类药物、β-受体阻滞剂和血小板抑制剂，以预防严重的心血管事件(CVE)，如心肌梗死。不幸的是，不坚持这些药物是很常见的，并且是由一系列复杂的因素造成的。研究发现，对于患有IHD的退伍军人来说，遗漏服药的最常见原因是健忘和粗心大意，这种情况因医疗保健系统而加剧：1)只被动地监测服药情况；2)在服药后很久才处理不服药的情况；3)试图以非系统、低效的方式逐个患者管理服药障碍，而不是使用系统的方法进行人口健康管理。以前纠正这一问题的努力经常采用非针对性、非实时、非量身定制的干预措施，结果令人失望。建议：与我们退伍军人管理局运营合作伙伴的意见一致，该建议利用了国家退伍军人临床评估、报告和跟踪系统(CART)计划的基础设施。CART将识别和监测经皮冠状动脉介入治疗(PCI)后患有IHD的退伍军人-这是IHD患者常用的心脏手术。CART每年在全美60多个心脏插管实验室(CCL)收集13,000多个经皮冠状动脉介入治疗的大量数据，是唯一适合这项拟议工作的设备。我们的总体假设是，多方面的、有针对性的、以患者为中心的药物依从性干预将改善他汀类药物、β-受体阻滞剂和血小板抑制剂的依从率，从而改善患有IHD的退伍军人的心脏健康。方法：采用一种新的、改良的阶梯式楔形试验设计对干预措施进行测试。这种干预措施被称为VA SEPPRMACI(经皮冠状动脉介入治疗后使用人群风险管理的二级事件预防)，将包括：对患者进行前瞻性实时依从性监测，并仅在患者表现出不依从性行为时(即，如果患者在血小板抑制剂到期重新填充4天后以及他汀类或β-受体阻滞剂到期7天后仍未重新用药)。干预将采用量身定做的、强度不断增加的方法，首先结合个性化短消息服务(SMS)文本消息和/或交互式语音应答(IVR)电话技术(取决于患者的偏好)。由于没有补充药物而导致这些部分不合格的患者会升级为训练有素的研究干预者。干预者将与患者联系，并使用结构化、系统化的方法解决每个患者特有的复杂的依从性障碍。我们将在4个CCL进行干预测试，并让12个站点作为常规护理控制。这一新的方法通过从12个额外的CCL中用同时的日常护理观察期补充干预前/日常护理观察期，提供了更大的统计能力。我们的运营合作伙伴建立的终端包括中间临床结果和难临床结果。具体地说，我们将评估干预对措施遵守情况(覆盖天数比例，目标1，主要终点)和12个月跟踪期间(目标2，探索性/次要终点)CVE的影响。我们还将确定实施和维持干预措施的成本，高于通常护理的成本和干预措施的增量成本效益(目标3)。

 DESCRIPTION (provided by applicant): Background: Ischemic heart disease (IHD) disease represents a major source of morbidity and mortality among veterans. Optimal management of IHD requires the use of medications, including statins, beta- blockers, and platelet inhibitors, to prevent serious cardiovascular event (CVE), such as myocardial infarctions. Unfortunately, non-adherence to these medications is common and results from a complex series of factors. Studies have found that for veterans with IHD, the most frequent causes of missed doses are forgetfulness and carelessness, a situation exacerbated by a health care system that: 1) only passively monitors adherence; 2) addresses instances of non-adherence long after they have occurred; 3) attempts to manage adherence barriers in an non-systematic, inefficient patient-by-patient manner, rather than through population health management using a systematic approach. Prior attempts to correct this problem have frequently employed non-targeted, non-real-time, un-tailored interventions, with disappointing results. Proposal: In concert with input from our VA operational partners, this proposal capitalizes on the infrastructure of the national VA Clinical Assessment, Reporting, and Tracking System (CART) Program. CART will identify and monitor veterans with IHD following percutaneous coronary intervention (PCI)-a cardiac procedure commonly used among IHD patients. Collecting extensive data at over 60 Cardiac Catheterization Laboratories (CCLs) for over 13,000 PCI's annually across the U.S., CART is uniquely suited for the proposed work. Our overall hypothesis posits that a multi-faceted, targeted, patient-centered medication adherence intervention will improve adherence rates for statins, beta-blockers, and platelet inhibitors and thus, the cardiac health of veterans with IHD. Methods: The intervention will be tested using a novel, modified stepped-wedge study design. Known as VA SEPPRMACI (Secondary Event Prevention using Population Risk Management After PCI), this intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 days after a platelet inhibitor was due to be refilled and 7 days after a statin or beta-blocker was due). The intervention will employ a tailored, escalating-intensity approach which begins with a combination of a personalized short messaging service (SMS) text messages and/or interactive voice response (IVR) telephone technology (depending on patient preference). Patients failing these components by not refilling their medication escalate to a trained research interventionalist. The interventionalist will contact the patient and address the complex adherence barriers specific to each patient using a structured, systematic approach. We will test the intervention at 4 CCLs and have 12 sites serve as usual care controls. This novel approach provides greater statistical power by supplementing the pre-intervention/usual care observation periods with concurrent usual care observation periods from the 12 additional CCLs. Endpoints established by our operational partners consist of both intermediate and hard clinical outcomes. Specifically, we will assess the effect of the intervention on a measure adherence (proportion of days covered, Aim 1, primary end point) and on CVEs during 12 months of follow-up (Aim 2, exploratory/secondary end point). We will also establish the cost to implement and maintain the intervention, above the cost of usual care, and the incremental cost effectiveness of the intervention (Aim 3).