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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06095284
Status
Enrolling By Invitation

Conditions

  • Dementia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
22,500,000 participants (estimated)

Arms

  • Arm: All nursing home residents included in the 2009-2021 MDS
    All nursing home residents included in the 2009-2021 MDS
  • Arm: Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition
    Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition

Primary Outcome Measure

Quarterly rate of use and mean dose of AEDs in US nursing homes [ Time Frame: The years 2009 to 2021 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298-

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By research site
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