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Search / Trial NCT06095284

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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Oct 19, 2023

Trial Information

Current as of October 26, 2025

Enrolling by invitation

Keywords

Mood Stabilizing Aed's Nursing Home

ClinConnect Summary

This is an observational study that looks at how often antiepileptic drugs (AEDs) and other mood-related medicines are used in U.S. nursing homes, and whether their use is linked to health problems. Researchers will examine national data from 2009–2021 to see the quarterly rate and average dose of AEDs, and then look at related outcomes such as falls, changes in memory and daily function, weight loss, use of hospice, death, ER visits, and hospitalizations. The plan also notes that AEDs are not FDA-approved for dementia symptoms and may carry risks, so the study aims to understand if increasing, unmonitored use is associated with more harm.

Who can be included and what to expect: The study will use de-identified, existing data and include adults age 21 and older who are long-stay nursing home residents (in the facility for more than 100 days) and nursing home clinicians who prescribe psychoactive drugs. Some residents may be excluded, such as those without continuous certain insurance coverage. There is no direct participation or treatment for individuals; the researchers will analyze records to describe prescribing trends and outcomes. Led by Virginia Commonwealth University with support from the National Institute on Aging, the project is currently enrolling by invitation, using data access rather than enrolling people, with results expected through 2027.

Gender

ALL

Eligibility criteria

  • 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.

About Virginia Commonwealth University

Virginia Commonwealth University (VCU) is a prominent academic institution and research leader located in Richmond, Virginia. Renowned for its commitment to advancing healthcare through innovative research and education, VCU plays a pivotal role in clinical trials aimed at improving patient outcomes and understanding complex health issues. The university boasts a collaborative environment, leveraging its diverse faculty expertise and state-of-the-art facilities to conduct rigorous clinical research across various medical disciplines. VCU's dedication to ethical research practices and community engagement ensures that its clinical trials are designed to address critical health challenges while prioritizing participant safety and well-being.

Locations

Richmond, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Jonathan Winter

Principal Investigator

Virginia Commonwealth University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported