Unintended Consequences: The Impact of VA Antipsychotic Reduction Efforts in Dementia

背景：鉴于对风险和收益的重大担忧，退伍军人管理局和医疗保险和医疗保险中心 医疗补助服务(CMS)各自都开始着手减少抗精神病药物的非标签使用 治疗几乎普遍且负担沉重的行为和心理症状的药物(AP) 痴呆(BPSD)。养老院(NH；在VA，社区生活)中使用AP的居民百分比 中心)被政策制定者用作BPSD的主要质量指标。除NH/CLCs外， 政策制定者还对社区环境中AP的高使用率感到担忧。使用1999年的退伍军人事务部数据- 2007年，我们之前发现，在2005年FDA黑匣子警告(关于 痴呆症中AP死亡率的增加)被其他类别的AP使用的增加所抵消 精神药物，精神药物的使用总体上没有减少。因此，政策完全集中在 减少AP的使用可能会导致“意想不到的后果”，比如提供者将患者转移到 具有更少益处和类似风险的替代精神药物类别，包括 苯二氮卓类、情绪稳定剂和抗抑郁药。而不是替代其他精神药物，多个 专家机构建议使用行为和环境干预措施作为首选替代办法 BPSD的APS。退伍军人管理局广泛实施了一项计划，以增加在《中图法》中对此类干预措施的接受 被称为STAR-VA的设置。然而，到目前为止，STAR-VA已经在少数CLC中实施，不是 靶向处方，其持续影响尚不清楚。 与退伍军人事务部精神卫生业务办公室合作，精神卫生服务， 精神药物安全倡议、STAR-VA、老年医学和长期护理以及药房福利 管理，这项研究将检查退伍军人管理局和非退伍军人管理局在系统和设施层面的后果 与痴呆症相关的举措旨在减少AP处方。 目标：目标1：确定系统级退伍军人管理局国家趋势(在《中图法》和社区环境中) 自第一次黑盒警告(2005年)至2014年，痴呆症患者的精神药物使用情况；目标2： 检查可能与痴呆患者开出AP处方有关的《中图法》水平变量(2014财年)；目标3： 验证退伍军人痴呆症患者在《中图法》和社区环境下的其他质量指标。 方法：在目标1中，采用中断时间序列分析方法，对VA全国卫生系统管理数据(FY 2005-2014)将用于审查减少痴呆症抗精神病药物使用的倡议的影响， 重点研究其他精神药物替代抗精神病药物的模式。我们还将评估在 退伍军人痴呆症患者AP和其他精神药物使用的警告后变化包括： 种族/民族；学术背景；地理位置。在目标2中，《中图法》设施按五分位数分类 将根据以下变量(源自2014财年数据)比较设施级别AP的平均处方(2013财年) 可能反映了对患有BPSD的居民的护理质量方面的意外和预期后果，包括：1) 其他精神药物使用、身体束缚使用和卫生保健利用；2)AP前的BPSD水平 处方；以及3)可能反映《中图法》护理质量和非药理学的有效措施 战略使用(文化变革的产物或ACCT)和实施STAR-VA(是/否)。通知人 目标1和目标2中关于与退伍军人护理质量相关的因素的研究结果 痴呆症，在目标3中，我们将使用一个由痴呆症专家和利益相关者组成的两轮改良德尔福专家小组 CARE和BPSD以验证额外的、与临床相关的质量指标。

Background: Given significant concerns about risks and benefits, the VA and the Centers for Medicare and Medicaid Services (CMS) have each embarked on initiatives to reduce off-label use of antipsychotic medications (APs) for the nearly universal and burdensome behavioral and psychological symptoms of dementia (BPSD). The percent of residents on APs in nursing homes (NH; in the VA, Community Living Centers or CLCs) is used by policymakers as the main quality indicator for BPSD. In addition to NH/CLCs, policymakers are also concerned with high rates of AP use in community settings. Using VA data from 1999- 2007, we previously found that AP use reductions following the 2005 FDA black box warning (regarding increased mortality for APs in dementia) were simply offset by increases in use of other classes of psychotropic medications, with no overall decrease in psychotropic use. Thus, policies focused entirely on reducing AP use may have caused “unintended consequences,” such as providers shifting patients to alternative psychotropic classes with even less evidence of benefit and similar risks, including benzodiazepines, mood stabilizers, and antidepressants. Rather than substituting other psychotropics, multiple expert bodies recommend the use of behavioral and environmental interventions as the preferred alternative to APs for BPSD. The VA has widely implemented a program to increase uptake of such interventions within CLC settings called STAR-VA. However, STAR-VA has to date been implemented in a minority of CLCs, does not target prescribing, and its sustained impact is unknown. In partnership with the VA Office of Mental Health Operations, Mental Health Services, the Psychotropic Drug Safety Initiative, STAR-VA, Geriatrics and Extended Care, and Pharmacy Benefits Management, this study will examine the system- and facility-level consequences of VA and non-VA initiatives related to dementia intended to reduce AP prescribing. Objectives: Aim 1: To determine system-level VA national trends (in both CLC and community settings) in psychotropic use among patients with dementia since the first black-box warning (2005) to 2014; Aim 2: To examine CLC-level variables that may be associated with AP prescribing in dementia (FY2014); and Aim 3: To validate additional quality indicators for VA patients with dementia for both CLC and community settings. Methods: In Aim 1, using interrupted time-series analyses, VA national health system administrative data (FY 2005-2014) will be used to examine the impact of initiatives to reduce antipsychotic use in dementia, with a focus on substitution patterns of other psychotropics for antipsychotics. We will also assess variation found in post-warning changes in AP and other psychotropic use in Veterans with dementia by variables including: race/ethnicity; academic affiliation; and geographic location. In Aim 2, CLC facilities classified into quintiles by mean facility-level AP prescribing (in FY 2013) will be compared on variables (derived from FY2014 data) that may reflect both unintended and desired consequences in quality of care for residents with BPSD, including: 1) other psychotropic use, physical restraint use, and health care utilization; 2) BPSD level prior to AP prescription; and 3) an available measure potentially reflecting quality of CLC care and non-pharmacologic strategy use (the Artifacts of Cultural Change or ACCT) and implementation of STAR-VA (yes/no). Informed by the findings from Aims 1 and 2 regarding factors that are associated with quality of care for veterans with dementia, in Aim 3, we will use a two-round modified Delphi panel of experts and stakeholders in dementia care and BPSD to validate additional, clinically-relevant quality indicators.