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Enrolling by Invitation

NCT Number: NCT06095284

Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic

Since the "National Partnership to Improve Dementia Care" debuted in 2012, almost all long-stay psychoactive prescribing has been graded by CMS, which has correlated to decreased use. However, some national data suggest that while these psychoactive medications are being used less, prescriptions of mood-stabilizing antiepileptic drugs (AEDs) have increased. Unlike all other psychoactive medications, AEDs prescribed in nursing homes are not mandatorily reported to CMS or graded in a quality-measure.

Enrolling by Invitation

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

Pilot studies from Virginia suggest increases in AEDs are concentrated entirely in dementia patients with no diagnosis of epilepsy and as a purposeful unmonitored alternative to antipsychotics. AEDs are not FDA approved for dementia symptoms, have weak efficacy evidence, and convey serious risk. Increasingly it seems likely that the Partnership's debut was an inflection point where the trend towards unmonitored alternative drugs for dementia symptoms sharply increased. Early Commonwealth data hints that the COVID pandemic represents a second critical point of inflection where the existing transition towards non-superior but unreported drugs is again rapidly accelerating. All outcomes associated with this evolving prescribing phenomenon remain unknown. That said, pilot data suggests that harms may be increasing without benefit, a development with relevance to all invested in improving dementia care including patients, caregivers, and policy makers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All long-stay nursing home residents will be included. We define long-stay nursing home residents as all individuals residing in a nursing facility place of service for more than 100 days
  • All nursing home clinicians prescribing psychoactive drugs will be included.

Exclusion criteria

  • Limited to nursing home residents with continuous fee-for-service or Medicare Advantage plans as well as continuous Part D coverage.
  • Residents without continuous fee-for-service insurance (less than 3 percent of nursing home population) will be excluded.
  • Less than 0.2% of nursing home residents are children; still, this study will be restricted to those > 21 years of age.
  • Nursing home residents who are discharged before the end of the quarterly study periods will also be excluded.
  • Residents with discharges for acute hospitalizations followed by facility reentry on the same record will not be excluded.
  • Non-prescribing clinicians and clinicians that do not prescribe psychoactive medications will be excluded.

Treatment and study plan

Pre-Extraction Phase

Other

This intervention requires the following procedures: Submitting data use agreement, MDS request defined and developed, Part D request, CMS public use file request defines and develop questionnaire

Extraction Phase

Other

Procedures include: Access VRDC for 2 years, Crosswalk CMS files and MDS using ID's, Preliminary analysis for validity/accuracy, Request revision/resubmission, Linked dataset created in VRDC and Distribute Questionnaire

Post-Extraction Phase

Other

Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation

Primary outcomes

  1. Quarterly rate of use and mean dose of AEDs in US nursing homes

    Time frame: The years 2009 to 2021

    Quarterly rate of use and mean dose of AEDs in US nursing homes 2009-2021

Secondary outcomes

  1. Quarterly rate of use of AEDs in US nursing homes for long-stay residents

    Time frame: The years 2009 to 2012

    Quarterly rate of use of AEDs in US nursing homes for long-stay residents with and without: dementia, seizure-epilepsy, psychiatric diagnoses, neuropathic pain, an appropriate diagnosis for AED use

  2. Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs

    Time frame: The years 2009 to 2021

    Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs from 2009 to 2021.

    Adverse health events include:

    • Detrimental nursing home outcomes including falls, cognitive scores, functional scores, harmful behaviors, weight loss, hospice, death
    • ER encounters (per 1000 nursing home days)
    • Hospitalizations (per 1000 nursing home days), potentially avoidable hospitalizations, medication related hospitalizations, costs of hospital care.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Prescribing Trends and Associated Outcomes of Antiepileptic Drugs and Other Psychoactive Medications in US Nursing Homes Surrounding the COVID-19 Pandemic

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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