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的最佳管理需要使用药物，包括他汀类药物、β受体阻滞剂和血小板抑制剂，以预防严重心血管事件（CVE），如心肌梗死。不幸的是，不遵守这些药物是常见的，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，错过剂量的最常见原因是健忘和粗心，这种情况因医疗保健系统而加剧：1）仅被动监测依从性; 2）在发生后很久才解决不依从性的情况; 3）试图以非系统的、低效的逐个患者的方式管理依从性障碍，而不是通过使用系统方法的人口健康管理。以前纠正这一问题的尝试经常采用非针对性、非实时、非定制的干预措施，结果令人失望。建议：与我们的VA运营合作伙伴的投入相一致，该提案利用了国家VA临床评估，报告和跟踪系统（CART）计划的基础设施。CART将在经皮冠状动脉介入治疗（PCI）后识别和监测患有IHD的退伍军人-这是IHD患者中常用的心脏手术。每年在美国60多个心导管实验室（CCL）收集13，000多例PCI的广泛数据，CART是唯一适合拟议的工作。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提高他汀类药物，β受体阻滞剂和血小板抑制剂的依从性，从而改善IHD退伍军人的心脏健康。方法：将使用一种新的、改良的阶梯楔形研究设计对干预进行测试。被称为VA SEPPRMACI（PCI后使用人群风险管理的二次事件预防），该干预将包括：对患者进行主动实时依从性监测，并仅在个人表现出不依从行为时才将其作为目标（即，如果患者在血小板抑制剂应补充后4天以上和他汀类药物或β受体阻滞剂应补充后7天以上未补充药物）。干预将采用量身定制的、强度递增的方法，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（取决于患者偏好）。由于未重新填充药物而导致这些组件失败的患者可升级至经过培训的研究介入医生。介入医生将联系患者，并使用结构化、系统化的方法解决每位患者特有的复杂依从性障碍。我们将在4个CCL测试干预措施，并将12个研究中心作为常规护理对照。这种新方法通过补充干预前/常规护理观察期与来自12个额外CCL的并行常规护理观察期，提供了更大的统计功效。 我们的运营合作伙伴建立的终点包括中间和硬临床结果。具体而言，我们将评估干预措施对测量依从性（覆盖天数比例，目标1，主要终点）和12个月随访期间的CVE（目标2，探索性/次要终点）的影响。我们还将确定实施和维持干预的成本，高于常规护理的成本，以及干预的增量成本效益（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).