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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06095284
• Other study ID #: HM20025382
• Secondary ID: R01AG074358
• Status: Enrolling by invitation
• Start date: September 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: October 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22500000
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quarterly rate of use and mean dose of AEDs in US nursing homes	Quarterly rate of use and mean dose of AEDs in US nursing homes 2009-2021	The years 2009 to 2021
Secondary	Quarterly rate of use of AEDs in US nursing homes for long-stay residents	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
Secondary	Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs	Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs from 2009 to 2021.; Adverse health events include: Detrimental nursing home outcomes including falls, cognitive scores, functional scores, harmful behaviors, weight loss, hospice, death; ER encounters (per 1000 nursing home days); Hospitalizations (per 1000 nursing home days), potentially avoidable hospitalizations, medication related hospitalizations, costs of hospital care.	The years 2009 to 2021