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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

22500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preventing ICU Subsyndromal Delirium Conversion to Delirium With Haloperidol

NCT01174290

Subsyndromal Delirium

COMPLETED PHASE4

Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)

NCT01181310

Dementia

COMPLETED PHASE1

Optimal Medication Management in Alzheimer's Disease and Dementia

NCT03984396

Dementia

COMPLETED NA

Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

NCT02028260

Delirium Respiratory Failure

WITHDRAWN PHASE3

Zydena on Cognitive Function of Alzheimer's Disease Patients

NCT01940952

Alzheimer's Disease

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All nursing home residents included in the 2009-2021 MDS

Pre-Extraction Phase

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Pre-Extraction Phase

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Post-Extraction Phase

Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No