Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095284
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-23
First Post:
2023-10-19
Brief Title:
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs and Other Psychoactive Medications in US Nursing Homes Surrounding the COVID-19 Pandemic
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Partnerships 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG074358 | NIH | None | httpsreporternihgovquickSearchR01AG074358 |