NCT06095284

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 22,500,000 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dementia

Interventions

Type	Name	Description
OTHER	Pre-Extraction Phase	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
OTHER	Extraction Phase	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
OTHER	Post-Extraction Phase	Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2023-10-23
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States