Clinical trial NCT06095284: Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Official title: Prescribing Trends and Associated Outcomes of Antiepileptic Drugs and Other Psychoactive Medications in US Nursing Homes Surrounding the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dementia
Keywords: Mood-stabilizing AED's
Nursing Home
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-23
Enrollment: 22500000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will only include de-identified data sets that are eligible for download and analysis and that meet the inclusion and exclusion criteria. Only those 21 years or older will be included.

Brief 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.

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.

Primary outcomes:
measure: Quarterly rate of use and mean dose of AEDs in US nursing homes
timeFrame: The years 2009 to 2021
Secondary outcomes:
measure: Quarterly rate of use of AEDs in US nursing homes for long-stay residents
timeFrame: The years 2009 to 2012
measure: Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs
timeFrame: The years 2009 to 2021
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jonathan Winter
role: PRINCIPAL_INVESTIGATOR
References: