EpilepsyNCT07663240
Epilepsy Emergency Department High Utilizer Program
An observational study of Epilepsy and Uncontrolled Seizures, run by Morehouse School of Medicine at 1 site in United States.
Trial summary
We believe that there are many reasons that people with epilepsy get their health care through the emergency department (ED) instead of through primary care or neurology. Our goal is to create program that will address these reasons. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epilepsy, Uncontrolled Seizures
- What is being tested?
- CHW-Led Transition-of-Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Dec 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult women with a confirmed diagnosis of epilepsy who are high utilizers of emergency department services at Grady Health System. Participants are enrolled through the Transition of Care (TOC) ED High Utilizer Program and have a history of frequent seizure-related ED visits. The study focuses on Black and Hispanic women residing in the Atlanta metropolitan area.
Who may be able to join
- Adult women aged 18 years or older
- Confirmed diagnosis of epilepsy documented in the electronic health record (EHR)
- Enrolled in the Grady Health System Transition of Care (TOC) ED High Utilizer Program
- History of three or more seizure-related emergency department visits within the past 12 months
- Self-identify as Black or Hispanic
- Reside in the Atlanta metropolitan area with intent to remain for at least 12 months
- Have access to a working phone for follow-up communication
Who cannot join
- No confirmed epilepsy diagnosis (e.g., non-epileptic seizures)
- Younger than 18 years of age
- Not identified as a high ED utilizer for seizure-related care
- Unable to provide informed consent due to cognitive impairment or psychiatric instability
- Regularly taking anti-epileptic medications with established adherence
- Scheduled neurology follow-up within 14 days of discharge or consistent primary care follow-up
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- Complex medical conditions that would limit participation in outpatient follow-up
- Non-English speaking
- Pregnant
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
Morehouse School of Medicine
Atlanta, Georgia, 30310
About this study
We believe that there are many reasons that people with epilepsy get their health care through the emergency department (ED) instead of through primary care or neurology. Our goal is to create program that will address these reasons. The creation of this program will be informed by use of the Grady electronic health records (EHR). We will use the EHR to describe people with epilepsy coming the Grady ED at a high frequency. We create a profile of these patients by examining their demographics and social determinants of health information in their EHR (Aim 1). We will then use that information to create a culturally and medically appropriate program for people with epilepsy (Aim 2). Next, we will test the new program, the Epilepsy Emergency Department High Utilizer Program (Aim 3). We believe this program may improve three things. It will first improve access to care by epilepsy and mental health doctors, and reduce ED visits. It may also help people to manage their triggers, track seizures, and take their medicines on time. And last, we believe it may improve seizure frequency and quality of life for people that are underserved in health care. With the lessons learned from the new program, we will explore ways to sustain the program at Grady and expand it to other health care facilities (Aim 4).
- Conditions
- Epilepsy, Uncontrolled Seizures
- Being tested
- CHW-Led Transition-of-Care Intervention
- Keywords
- Epilepsy, Uncontrolled seizured, Frequent ED use, High utilizers, Community Health Worker, Care coordination, African American / Black, Underserved populations, Social determinants of health, Multidisciplinary care, Integrated care, Transitions of Care Program
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW-Led Transition-of-Care InterventionBehavioural
Participants receive a community health worker (CHW)-led transition-of-care intervention for adults with epilepsy who frequently use emergency department services. Over 9-12 months, the CHW provides home visits and phone follow-up to support seizure self-management, medication adherence, and care coordination.
The CHW assists with appointment scheduling, connects participants to healthcare and community resources, and addresses social needs such as transportation and access to care. The goal is to improve continuity of care and reduce emergency department utilization.
| Study group | Role | What they receive |
|---|---|---|
| CHW-Led Transition-of-Care Intervention | This study evaluates a community health worker (CHW)-led transition-of-care intervention for adults with epilepsy who are high utilizers of emergency department services. Participants are enrolled following identification through the Grady Health System Transition of Care (TOC) ED High Utilizer Program.
Participants receive ongoing support from a trained CHW over a 9-12 month period. The intervention includes regular home visits and phone follow-up to support epilepsy self-management, including education on seizure recognition, medication adherence, identification of seizure triggers, and reinforcement of treatment plans.
The CHW provides care coordination by assisting with appointment scheduling, facilitating communication with healthcare providers, and supporting linkage to neurology, primary care, behavioral health, and community-based services. The intervention also addresses social determinants of health, including transportation, housing, and access to resources that may impac Receives: Behavioral: CHW-Led Transition-of-Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Utilization
Reduced emergency department visits
Measured: Baseline to 9-12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Grady Health System, Emory University, UCB Pharma, Epilepsy Foundation, NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Rakale Quarells, PhD, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663240
- Sponsor's protocol ID
- 12345
- Other IDs
- FY2025-56
- Status last verified
- May 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will include demographic characteristics, clinical variables (e.g., seizure frequency, emergency department utilization, medication adherence), and participant-reported outcomes related to epilepsy self-management, quality of life, and behavioral health measures collected during the study period.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Emergency Department High Utilizer Program
- ClinicalTrials.gov ID
- NCT07663240
- Acronym / sponsor ID
- 12345
- Conditions
- Epilepsy, Uncontrolled Seizures
- Keywords
- Epilepsy, Uncontrolled seizured, Frequent ED use, High utilizers, Community Health Worker, Care coordination, African American / Black, Underserved populations
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- Grady Health System, Emory University, UCB Pharma, Epilepsy Foundation, NYU Langone Health
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jun 2026 (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.
We believe that there are many reasons that people with epilepsy get their health care through the emergency department (ED) instead of through primary care or neurology. Our goal is to create program that will address these reasons. The creation of this program will be informed by use of the Grady electronic health records (EHR). We will use the EHR to describe people with epilepsy coming the Grady ED at a high frequency. We create a profile of these patients by examining their demographics and social determinants of health information in their EHR (Aim 1). We will then use that information to create a culturally and medically appropriate program for people with epilepsy (Aim 2). Next, we will test the new program, the Epilepsy Emergency Department High Utilizer Program (Aim 3). We believe this program may improve three things. It will first improve access to care by epilepsy and mental health doctors, and reduce ED visits. It may also help people to manage their triggers, track seizures, and take their medicines on time. And last, we believe it may improve seizure frequency and quality of life for people that are underserved in health care. With the lessons learned from the new program, we will explore ways to sustain the program at Grady and expand it to other health care facilities (Aim 4).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHW-Led Transition-of-Care Intervention | – | Behavioral: CHW-Led Transition-of-Care InterventionThis study evaluates a community health worker (CHW)-led transition-of-care intervention for adults with epilepsy who are high utilizers of emergency department services. Participants are enrolled following identification through the Grady Health System Transition of Care (TOC) ED High Utilizer Program. Participants receive ongoing support from a trained CHW over a 9-12 month period. The intervention includes regular home visits and phone follow-up to support epilepsy self-management, including education on seizure recognition, medication adherence, identification of seizure triggers, and reinforcement of treatment plans. The CHW provides care coordination by assisting with appointment scheduling, facilitating communication with healthcare providers, and supporting linkage to neurology, primary care, behavioral health, and community-based services. The intervention also addresses social determinants of health, including transportation, housing, and access to resources that may impac |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult women with a confirmed diagnosis of epilepsy who are high utilizers of emergency department services at Grady Health System. Participants are enrolled through the Transition of Care (TOC) ED High Utilizer Program and have a history of frequent seizure-related ED visits. The study focuses on Black and Hispanic women residing in the Atlanta metropolitan area.
Key inclusion criteria (7 listed)
- Adult women aged 18 years or older
- Confirmed diagnosis of epilepsy documented in the electronic health record (EHR)
- Enrolled in the Grady Health System Transition of Care (TOC) ED High Utilizer Program
- History of three or more seizure-related emergency department visits within the past 12 months
- Self-identify as Black or Hispanic
Key exclusion criteria (9 listed)
- No confirmed epilepsy diagnosis (e.g., non-epileptic seizures)
- Younger than 18 years of age
- Not identified as a high ED utilizer for seizure-related care
- Unable to provide informed consent due to cognitive impairment or psychiatric instability
- Regularly taking anti-epileptic medications with established adherence
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 |
|---|---|---|
| CHW-Led Transition-of-Care InterventionParticipants receive a community health worker (CHW)-led transition-of-care intervention for adults with epilepsy who frequently use emergency department services. Over 9-12 months, the CHW provides home visits and phone follow-up to support seizure self-management, medication adherence, and care coordination. The CHW assists with appointment scheduling, connects participants to healthcare and community resources, and addresses social needs such as transportation and access to care. The goal is to improve continuity of care and reduce emergency department utilization. | Behavioural | CHW-Led Transition-of-Care Intervention |
Primary outcome
Emergency Department Utilization
Time frame: Baseline to 9-12 months post-enrollment
Reduced emergency department visits
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 23 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will include demographic characteristics, clinical variables (e.g., seizure frequency, emergency department utilization, medication adherence), and participant-reported outcomes related to epilepsy self-management, quality of life, and behavioral health measures collected during the study period.
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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.
Rakale Quarells, PhD principal investigator
Morehouse School of Medicine
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 Epilepsy and Uncontrolled Seizures, run by Morehouse School of Medicine 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 7 inclusion and 9 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 23 Jun 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?
Emergency Department Utilization (time frame: Baseline to 9-12 months post-enrollment). 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 23 Jun 2026.