Tendances en matière de prescription et résultats associés des médicaments antiépileptiques dans les maisons de retraite aux États-Unis dans le cadre de la pandémie de COVID-19
Tendances en matière de prescription et résultats associés des médicaments antiépileptiques et autres médicaments psychoactifs dans les maisons de retraite aux États-Unis dans le cadre de la pandémie de COVID-19
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
-
-
Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quarterly rate of use and mean dose of AEDs in US nursing homes
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quarterly rate of use of AEDs in US nursing homes for long-stay residents
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jonathan Winter, Virginia Commonwealth University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HM20025382
- R01AG074358 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
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