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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
All nursing home residents included in the 2009-2021 MDS
  • 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
  • Other: 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
  • Other: Post-Extraction Phase
    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
  • 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
  • Other: 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
  • Other: Post-Extraction Phase
    Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation

Recruiting Locations

More Details

NCT ID
NCT06095284
Status
Enrolling by invitation
Sponsor
Virginia Commonwealth University

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.