DementiaNCT06095284
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
An observational study of Dementia, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Pre-Extraction Phase, Extraction Phase and Post-Extraction Phase
- How many people
- 22,500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will only include de-identified data sets that are eligible for download and analysis and that meet the inclusion and exclusion criteria. Only those 21 years or older will be included.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Prescribing Trends and Associated Outcomes of Antiepileptic Drugs and Other Psychoactive Medications in US Nursing Homes Surrounding the COVID-19 Pandemic
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Pre-Extraction Phase, Extraction Phase, Post-Extraction Phase
- Keywords
- Mood-stabilizing AED's, Nursing Home
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Extraction PhaseOther
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 PhaseOther
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 PhaseOther
Procedures include: De-identified data securely stored, analysis, dissemination and knowledge translation
| Study group | Role | What they receive |
|---|---|---|
| All nursing home residents included in the 2009-2021 MDS | All nursing home residents included in the 2009-2021 MDS Receives: Other: Pre-Extraction Phase; Other: Extraction Phase; Other: Post-Extraction Phase | |
| Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition | Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition Receives: Other: Pre-Extraction Phase; Other: Extraction Phase; Other: Post-Extraction Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The years 2009 to 2021
Secondary outcomes (2)
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
Measured: The years 2009 to 2012
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.
Measured: The years 2009 to 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Sep 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 22,500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jonathan Winter, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095284
- Sponsor's protocol ID
- HM20025382
- Other IDs
- R01AG074358
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescribing Trends and Associated Outcomes of Antiepileptic Drugs and Other Psychoactive Medications in US Nursing Homes Surrounding the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT06095284
- Acronym / sponsor ID
- HM20025382
- Conditions
- Dementia
- Keywords
- Mood-stabilizing AED's, Nursing Home
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22,500,000 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All nursing home residents included in the 2009-2021 MDS | – | Other: Pre-Extraction Phase, Other: Extraction Phase, Other: Post-Extraction PhaseAll nursing home residents included in the 2009-2021 MDS |
| Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition | – | Other: Pre-Extraction Phase, Other: Extraction Phase, Other: Post-Extraction PhaseNursing home and non-nursing home residents diagnosed with an AD/ADRD condition |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will only include de-identified data sets that are eligible for download and analysis and that meet the inclusion and exclusion criteria. Only those 21 years or older will be included.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Extraction PhaseThis 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 | All nursing home residents included in the 2009-2021 MDS, Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition |
| Extraction PhaseProcedures 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 | All nursing home residents included in the 2009-2021 MDS, Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition |
| Post-Extraction PhaseProcedures include: De-identified data securely stored, analysis, dissemination and knowledge translation | Other | All nursing home residents included in the 2009-2021 MDS, Nursing home and non-nursing home residents diagnosed with an AD/ADRD condition |
Primary outcome
Quarterly rate of use and mean dose of AEDs in US nursing homes
Time frame: The years 2009 to 2021
Quarterly rate of use and mean dose of AEDs in US nursing homes 2009-2021
2 secondary outcomes
Quarterly rate of use of AEDs in US nursing homes for long-stay residents
Time frame: The years 2009 to 2012
Quarterly rate of adverse health events among US nursing home residents prescribed or not prescribed AEDs
Time frame: The years 2009 to 2021
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Winter principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quarterly rate of use and mean dose of AEDs in US nursing homes (time frame: The years 2009 to 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.