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

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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.