跳至主要内容
临床试验/NCT06095284
NCT06095284Enrolling By Invitation不适用

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

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 22,500,000 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
22,500,000
试验地点
1
主要终点
Quarterly rate of use and mean dose of AEDs in US nursing homes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Quarterly rate of use and mean dose of AEDs in US nursing homes

时间窗: The years 2009 to 2021

Quarterly rate of use and mean dose of AEDs in US nursing homes 2009-2021

次要结局

  • Quarterly rate of use of AEDs in US nursing homes for long-stay residents(The years 2009 to 2012)
  • Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs(The years 2009 to 2021)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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