- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07663240
Epilepsy Emergency Department High Utilizer Program
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30310
- Morehouse School of Medicine
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Complex medical conditions that would limit participation in outpatient follow-up
- Non-English speaking
- Pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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 |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Emergency Department Utilization
Tidsramme: Baseline to 9-12 months post-enrollment
|
Reduced emergency department visits
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Baseline to 9-12 months post-enrollment
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rakale Quarells, PhD, Morehouse School of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12345 (Danish Center for Healthcare Improvements)
- FY2025-56 (Andet bevillings-/finansieringsnummer: UCB Pharma)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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