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

背景：考虑到对风险和收益的重大担忧，VA和医疗保险中心以及 医疗补助服务（CMS）已经开始采取措施，以减少抗精神病药物的标签外使用 药物（AP）几乎普遍和繁重的行为和心理症状， 痴呆（BPSD）。养老院（NH;在VA，社区生活）中AP居民的百分比 决策者将其作为《可持续发展战略》的主要质量指标。除了NH/CLC， 政策制定者还对社区环境中AP的高使用率表示关注。使用1999年的VA数据- 2007年，我们以前发现，在2005年FDA黑盒警告（关于 痴呆症中AP的死亡率增加）被其他类别的 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的使用可能会造成“意想不到的后果”，例如医疗服务提供者将患者转移到 替代的精神类药物，甚至更少的证据表明，利益和类似的风险，包括 苯二氮平类情绪稳定剂和抗抑郁药而不是替代其他精神药物，多种 专家机构建议使用行为和环境干预作为首选替代方案， BPSD的AP。退伍军人事务部广泛实施了一项计划，以增加在CLC内采用此类干预措施 称为STAR-VA的设置。然而，STAR-VA迄今已在少数社区学习中心实施， 目标处方，其持续影响是未知的。 与退伍军人事务部心理健康行动办公室，心理健康服务， 精神药物安全倡议，STAR-VA，老年病和长期护理，以及药房福利 管理，本研究将探讨系统和设施层面的后果，VA和非VA 旨在减少AP处方的痴呆症相关举措。 目标：目标1：确定系统一级的脆弱性和适应性国家趋势（在社区联络中心和社区环境中）， 自第一次黑盒警告（2005年）至2014年，痴呆症患者中精神药物的使用;目标2： 检查可能与痴呆症AP处方相关的CLC水平变量（2014财年）;目标3： 验证CLC和社区环境中VA痴呆患者的其他质量指标。 方法：在目标1中，使用中断时间序列分析，VA国家卫生系统管理数据（FY 2005-2014年）将用于检查减少痴呆症抗精神病药物使用的举措的影响， 重点关注其他精神药物替代抗精神病药物的模式。我们还将评估发现的变化， 痴呆退伍军人中AP和其他精神药物使用的警告后变化，变量包括： 种族/民族;学术联系;和地理位置。在目标2中，CLC设施按以下方式分为五类： 平均机构级AP处方（2013财年）将根据变量（源自2014财年数据）进行比较， 可能反映了BPSD患者护理质量的非预期和预期后果，包括：1） 其他精神药物使用、身体约束使用和卫生保健使用; 2）AP前的BPSD水平 处方;和3）可能反映CLC护理质量和非药物的可用措施 战略的使用（文化变革的人工制品或ACCT）和STAR-VA的实施（是/否）。通知 目标1和2中关于与退伍军人护理质量相关的因素的研究结果， 在目标3中，我们将使用由痴呆症专家和利益相关者组成的两轮改良德尔菲小组 护理和BPSD来验证额外的临床相关质量指标。

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.