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

Virginia Commonwealth University (VCU)

Status

Invitation-only

Conditions

Dementia

Treatments

Other: Extraction Phase

Other: Post-Extraction Phase

Other: Pre-Extraction Phase

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT06095284

R01AG074358 (U.S. NIH Grant/Contract)

HM20025382

Details and patient eligibility

About

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.

Full 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.

Enrollment

22,500,000 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.