Forskrivningstrender og tilknyttede utfall av antiepileptiske legemidler i amerikanske sykehjem rundt COVID-19-pandemien
Forskrivning av trender og tilknyttede utfall av antiepileptika og andre psykoaktive medisiner i amerikanske sykehjem rundt COVID-19-pandemien
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
Virginia
-
Richmond, Virginia, Forente stater, 23298
- Virginia Commonwealth University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
All nursing home residents included in the 2009-2021 MDS
All nursing home residents included in the 2009-2021 MDS |
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 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 Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation |
|
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 |
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 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 Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quarterly rate of use and mean dose of AEDs in US nursing homes
Tidsramme: The years 2009 to 2021
|
Quarterly rate of use and mean dose of AEDs in US nursing homes 2009-2021 |
The years 2009 to 2021
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quarterly rate of use of AEDs in US nursing homes for long-stay residents
Tidsramme: The years 2009 to 2012
|
Quarterly rate of use of AEDs in US nursing homes for long-stay residents with and without: dementia, seizure-epilepsy, psychiatric diagnoses, neuropathic pain, an appropriate diagnosis for AED use |
The years 2009 to 2012
|
|
Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs
Tidsramme: The years 2009 to 2021
|
Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs from 2009 to 2021. Adverse health events include:
|
The years 2009 to 2021
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jonathan Winter, Virginia Commonwealth University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HM20025382
- R01AG074358 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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