Prescribing Trends and Associated Outcomes of AntiepilepticDrugs and Other Psychotropic Medications in US Nursing Homes:Proposal for a Mixed Methods Investigation

Background: Pilot data suggest that off-label, unmonitored antiepileptic drug prescribing for behavioral and psychologicalsymptoms of dementia is increasing, replacing other psychotropic medications targeted by purposeful reduction efforts. Thistrend accelerated during the COVID-19 pandemic. Although adverse outcomes related to this trend remain unknown, preliminaryresults hint that harms may be increasing and concentrated in vulnerable populations.Objective: Using a mixed methods approach including both a retrospective secondary data analysis and a national cliniciansurvey, this study aims to describe appropriate and potentially inappropriate antiepileptic and other psychoactive drug prescribingin US nursing homes (NHs), characteristics and patient-oriented outcomes associated with this prescribing, and how thesephenomena may be changing under the combined stressors of the COVID-19 pandemic and the pressure of reduction initiatives.Methods: To accomplish the objective, resident-level, mixed-effects regression models and interrupted time-series analyseswill draw on cohort elements linked at an individual level from the Centers for Medicare and Medicaid Services'(CMS) MinimumData Set, Medicare Part D, Medicare Provider Analysis and Review, and Outpatient and Public Use Files. Quarterly cohorts ofNH residents (2009-2021) will incorporate individual-level data, including demographics; health status; disease variables;psychotropic medication claims; comprehensive NH health outcomes; hospital and emergency department adverse events; andNH details, including staffing resources and COVID-19 statistics. To help explain and validate findings, we will conduct a nationalqualitative survey of NH prescribers regarding their knowledge and beliefs surrounding changing approaches to dementia careand associated outcomes.Results: Funding was obtained in September 2022. Institutional review board exemption approval was obtained in January2023. The CMS Data Use Agreement was submitted in May 2023 and signed in March 2024. Data access was obtained in June2024. Cohort creation is anticipated by January 2025, with crosswalks finalized by July 2025. The first survey was fielded inOctober 2023 and published in July 2024. The second survey was fielded in March 2024. The results are in review as of July2024. Iterative survey cycles will continue biannually until December 2026. Multidisciplinary dissemination of survey analysis results began in July 2023, and dissemination of secondary data findings is anticipated to begin January 2025. These processesare ongoing, with investigation to wrap up by June 2027.Conclusions: This study will detail appropriate and inappropriate antiepileptic drug use and related outcomes in NHs anddescribe disparities in long-stay subpopulations treated or not treated with psychotropics. It will delineate the impact of thepandemic in combination with national policies on dementia management and outcomes. We believe this mixed methods approach,including processes that link multiple CMS data sets at an individual level and survey-relevant stakeholders, can be replicatedand applied to evaluate a variety of patient-oriented questions in diverse clinical populations.