Secondary Event Prevention using Population Risk Management After PCI

PCI 后使用群体风险管理预防次要事件

基本信息

批准号：
9086073
负责人：
LIRON CAPLAN
金额：
--
依托单位：
VA EASTERN COLORADO HEALTH CARE SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-01 至 2020-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9086073
关键词：
Accounting Address Address Adherence Adherence Adrenergic Antagonists Adrenergic Antagonists Adrenergic beta-Antagonists Adrenergic beta-Antagonists Affect Affect Aspirin Aspirin Behavior Blood flow Blood flow Businesses Businesses Cardiac Cardiac Cardiac Catheterization Procedures Cardiac Catheterization Procedures Cardiac Death Cardiac Death Cardiac health Cardiac health Cardiology Cardiology Cardiovascular system Cardiovascular system Cause of Death Cause of Death Cessation of life Cessation of life Chronic Chronic Clinical Clinical Clinical assessments Clinical assessments Coenzyme A Coenzyme A Complex Complex Coronary Artery Bypass Coronary Artery Bypass Cost Effectiveness Analysis Cost Effectiveness Analysis Cost of Illness Cost of Illness Data Data Dimensions Dimensions Disease Disease Dose Dose Effectiveness Effectiveness Effectiveness of Interventions Effectiveness of Interventions Event Event Exhibits Exhibits Health Care Costs Health Care Costs Health Services Health Services Healthcare Systems Healthcare Systems Heart Heart Individual Individual Infrastructure Intelligence Intelligence Intervention Intervention Laboratories Laboratories Measures Measures Medical Medical Methods Methods Modality Modality Modification Modification Monitor Monitor Morbidity - disease rate Morbidity - disease rate Myocardial Infarction Myocardial Infarction Myocardial Ischemia Myocardial Ischemia Outcome Outcome Outcomes Research Outcomes Research Oxidoreductase Oxidoreductase Patient Monitoring Patient Monitoring Patient Preferences Patient Preferences Patients Patients Pharmaceutical Preparations Pharmaceutical Preparations Platelet Inhibitors Platelet Inhibitors Population Population Prevention Prevention Procedures Procedures Public Health Public Health Quality of Care Quality of Care Randomized Randomized Recurrence Recurrence Reporting Reporting Research Design Research Design Research Infrastructure Research Personnel Research Personnel Research Training Research Training Risk Risk Risk Management Risk Management Scientist Scientist Series Series Services Services Site Site Source Source Structure Structure System System Technology Technology Telephone Telephone Testing Testing Text Text Messaging Time Time United States United States Veterans Veterans Voice Voice Work Work World Health Organization World Health Organization adherence rate arm base base beta-adrenergic receptor beta-adrenergic receptor cardiovascular health cardiovascular health clopidogrel clopidogrel cost cost cost effectiveness design design disability disability economic implication economic implication follow-up follow-up health economics health management high risk high risk improved improved incremental cost-effectiveness inhibitor/antagonist inhibitor/antagonist innovation innovation intervention effect intervention effect medication compliance medication compliance medication nonadherence mortality mortality multi-component intervention multi-component intervention novel novel novel strategies novel strategies optimal treatments patient engagement patient oriented patient oriented percutaneous coronary intervention percutaneous coronary intervention pharmacy benefit pharmacy benefit population health population health prevent prevent primary endpoint primary outcome primary outcome programs programs response response secondary endpoint thienopyridine thienopyridine tool tool treatment arm treatment as usual treatment as usual usual care arm

项目摘要

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).

描述（由申请人提供）：背景：缺血性心脏病 (IHD) 是退伍军人发病和死亡的一个主要来源。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)、不幸的是，不坚持服药的情况很常见，这是由一系列复杂因素造成的。研究发现，对于患有 IHD 的退伍军人来说，错过服药的最常见原因是健忘和服药。粗心大意，医疗保健系统会加剧这种情况：1）仅被动地监测依从性；2）在发生不依从性情况后很长时间才解决；3）试图通过非系统性、低效的方式管理患者的依从性障碍。 - 患者的方式，而不是通过使用系统方法进行人口健康管理，以前经常采用非针对性、非实时、非定制的干预措施，但结果令人失望。我们的弗吉尼亚州该提案利用了国家 VA 临床评估、报告和跟踪系统 (CART) 计划的基础设施，CART 将识别和监测经皮冠状动脉介入治疗 (PCI)（一种 IHD 患者常用的心脏手术）后患有 IHD 的退伍军人。 CART 每年在美国 60 多个心导管实验室 (CCL) 收集超过 13,000 例 PCI 的大量数据，非常适合我们的拟议工作。总体假设认为，多方面、有针对性、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率，从而改善患有 IHD 的退伍军人的心脏健康。方法：将使用该干预措施进行测试。一种新颖的、改进的阶梯式楔形研究设计，称为 VA SEPPRMACI（PCI 后使用人群风险管理预防二次事件），该干预措施将包括：主动实时监测患者的依从性，并仅在患者有以下情况时才针对患者。表现出不依从行为（即，如果患者在应补充血小板抑制剂后超过 4 天以及应补充他汀类药物或 β 受体阻滞剂后 7 天仍未补充药物），则干预措施将采用量身定制的逐步升级的措施。 - 强度方法，首先结合个性化短信服务 (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），而未能满足这些要求的患者则未补充药物。升级为训练有素的研究干预医生。干预医生将联系患者，并使用结构化、系统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 上测试干预措施，并在 12 个地点作为常规护理控制。该方法通过补充干预前/常规护理观察期和由我们的运营合作伙伴建立的 12 个额外 CCL 终点（包括中期和硬临床结果）来提供更大的统计能力。具体来说，我们将评估效果。措施依从性（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）的干预措施的影响我们还将确定实施和实施的成本。维持干预措施高于常规护理的成本，以及干预措施的增量成本效益（目标 3）。