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

Since the "National Partnership to Improve Dementia Care" debuted in 2012, almost alllong-stay psychoactive prescribing has been graded by CMS, which has correlated todecreased use. However, some national data suggest that while these psychoactivemedications are being used less, prescriptions of mood-stabilizing antiepileptic drugs(AEDs) have increased. Unlike all other psychoactive medications, AEDs prescribed innursing 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.

Enrolling by invitation
Dementia

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 21 Years ~ Maximum: N/A
Countries
United States
Locations

Virginia Commonwealth University
Richmond, Virginia, United States

Jonathan Winter, Principal Investigator
Virginia Commonwealth University

National Institute on Aging (NIA)
NCT Number
Keywords
Mood-stabilizing AED's
Nursing Home
MeSH Terms
COVID-19