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Набор по приглашению NCT06095284

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

— Наблюдательное Dementia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pre-Extraction Phase, Extraction Phase, Post-Extraction Phase.
Кому может быть актуально
Состояния в реестре: Dementia. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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
  • Другое 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
  • Другое Post-Extraction Phase
    Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation

Первичные конечные точки

  • Quarterly rate of use and mean dose of AEDs in US nursing homes [Срок оценки: The years 2009 to 2021]
Вторичные конечные точки (2)
  • Quarterly rate of use of AEDs in US nursing homes for long-stay residents [Срок оценки: The years 2009 to 2012]
  • Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs [Срок оценки: The years 2009 to 2021]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06095284 · HM20025382 · R01AG074358

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗