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

意想不到的后果：减少 VA 抗精神病药物治疗对痴呆症的影响

• 批准号: 9873826
• 负责人: Kara Zivin
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-01-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9873826
• 关键词: Aggressive behavior; Agitation; Antidepressive Agents; Antipsychotic Agents; Anxiety; Behavior; Behavior Therapy; Behavioral Symptoms; Benefits and Risks; Benzodiazepines; CLC Gene; Caring; Clinical; Clinical Data; Data; Data Set; Dementia; Ethnic Origin; Geographic Locations; Geriatrics; Health system; Interruption; Intervention; Long-Term Care; Measures; Mental Depression; Mental Health; Mental Health Services; Methods; Minority; Mood stabilizers; Morphologic artifacts; Nursing Homes; Patients; Pattern; Pharmaceutical Preparations; Physical Restraint; Policies; Provider; Psychoses; Psychotropic Drugs; Quality Indicator; Quality of Care; Race; Risk; Site; Sleep Disorders; System; Time Series Analysis; United States Centers for Medicare and Medicaid Services; Variant; Veterans; clinically relevant; community living; community setting; dementia care; environmental intervention; health care service utilization; improved; medication safety; mortality; off-label use; operation; pharmacy benefit; programs; psychological symptom; social; tool; trend; uptake

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.

背景：鉴于对风险和利益的重大关注，VA和Medicare的中心 Medicaid Services（CMS）各自采取了减少标签外使用抗精神病药的计划 药物（AP），用于几乎普遍和朴实的行为和心理症状 痴呆症（BPSD）。护士之家的AP居民百分比（NH；在VA中，社区生活 决策者将中心或CLCS）用作BPSD的主要质量指标。除了NH/CLC， 政策制定者还关注社区环境中AP的高度使用率。使用1999年的VA数据 - 2007年，我们以前发现AP在2005 FDA黑匣子警告后使用降低（关于） 痴呆症中AP的死亡率增加）仅被其他类别的使用增加而被抵消 精神药物的精神药物总体上没有降低。那是完全关注的政策 减少AP的使用可能导致“意外后果”，例如提供者将患者转移到 替代性精神阶级，具有较少的利益证据和类似风险的证据，包括 苯二氮卓，情绪稳定剂和抗抑郁药。而不是代替其他精神药物，而是多种 专家机构建议将行为和环境干预措施用作首选的替代方案 BPSD的AP。 VA已广泛实施了一个计划，以增加CLC中此类干预措施的吸收 设置称为star-va。但是，迄今为止，Star-VA已在少数CLC中实施，没有 目标处方及其持续影响尚不清楚。 与VA心理健康运营，心理健康服务办公室合作， 精神药物安全计划，星VA，老年医学和扩展护理以及药房福利 管理层，这项研究将检查VA和非VA的系统和设施级别的后果 与痴呆症有关的计划旨在减少AP处方。 目标：目标1：确定系统级VA国家趋势（在CLC和社区环境中） 自第一个黑盒警告（2005年）至2014年以来，痴呆症患者的精神毒素使用；目标2：到 检查可能与痴呆症中AP处方有关的CLC级变量（2014财年）；和目标3： 验证CLC和社区环境的VA痴呆症患者的其他质量指标。 方法：在AIM 1中，使用中断的时间序列分析，VA国家卫生系统行政数据（FY） 2005-2014）将用于研究减少痴呆症抗精神病药物的倡议的影响， 专注于抗精神病药的其他精神药物的替代模式。我们还将评估在 在痴呆症退伍军人中，AP和其他精神上使用变化的变化变化的变化包括： 种族/种族；学术会员；和地理位置。在AIM 2中，CLC设施将 平均设施级AP处方（2013财年）将在变量（从2014财年数据中得出）进行比较 可能反映了BPSD居民的护理质量的意外和期望的后果，包括：1） 其他精神使用，身体约束使用和医疗保健利用； 2）BPSD级别之前 处方; 3）可用的测量可能反映了CLC护理和非药物的质量 策略使用（文化变革或ACCT的工件）和Star-VA的实施（是/否）。告知 AIMS 1和2的发现与与退伍军人的护理质量相关的因素 痴呆症，在AIM 3中，我们将使用痴呆症专家和利益相关者的两轮修改后的Delphi小组 CARE和BPSD验证其他与临床相关的质量指标。