- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07713849
Transition Care for FEP (TCT FEP)
Adapting and Improving Transition Care for First Episode Psychosis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
For individuals experiencing the onset of a psychotic disorder such as schizophrenia, the period of time around their first hospitalization and subsequent stabilization in outpatient care is a critical juncture for establishing the trajectory of their recovery. Engaging early and consistently in care not only yields more rapid stabilization of symptoms, but it is also associated with improved long-term prognosis and better quality of life. In recent years, the field has focused on developing a gold standard outpatient treatment model for individuals experiencing their first episode of psychosis (FEP), called Coordinated Specialty Care (CSC). This model features wraparound services, shared decision making with the young adult experiencing FEP, peer support, and caregiver engagement. It has been consistently shown to improve outcomes for these individuals. Unfortunately, however, many patients who would qualify for enrollment in CSC programs are unable to benefit from this effective treatment. That is, there is a vulnerable period in between the initial diagnosis and stabilization of a psychotic disorder-often occurring on inpatient care units-and successful engagement in the CSC program. In this vulnerable care transition time, many patients are lost to follow-up, thus losing the treatment gains of acute inpatient care and failing to take advantage of progressing further into recovery via CSCs. The barriers to effective transition between these two treatment settings are numerous: poor insight regarding the need for continued care, inadequate caregiver support, insufficient knowledge of the healthcare system, practical/structural constraints such as lack of transportation, long wait times for the initial appointment, and more. In our own preliminary data from one inpatient unit, 76% of qualifying FEP individuals did not successfully attend an outpatient CSC appointment. Accordingly, there is a significant clinical care gap in practice: CSC may be the best outpatient treatment program for individuals with FEP, but many are unable to benefit as a result of being lost to follow-up. In this project, the investigators will pilot an intervention designed to close this gap. The investigators have adapted the concept of transitional care, used in other medical settings, for hospitalized FEP individuals to facilitate engagement in outpatient CSC care. A Transition Care Team (TCT) will engage with FEP patients before and after hospitalization, incorporating CSC elements such as family engagement, peer support, and case management. Importantly, it will also be resourced to provide interim medication management, transportation, etc., which will be offered until the patient engages with CSC for the next stage of their care. This integrates two established care models-transitional care and CSC-for FEP populations. The investigators expect this approach will be successful by addressing targets at the patient, provider, and system levels.
Given the emphasis on transitional care between acute and outpatient settings, this intervention will begin on the inpatient unit itself shortly after the FEP individual begins to stabilize. In preparation for discharge, the TCT will meet individually with the FEP patient and their caregivers to conduct a needs assessment for the transition period. This team will then continue following the patient after discharge, maintaining contact with the individual, their caregivers, and the CSC program they are referred to, for up to 6 weeks or until attendance of the CSC appointment.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Madeline Perez Lab Manager, B.S
- Telefonní číslo: 773-712-9178
- E-mail: keedylab@gmail.com
Studijní místa
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Illinois
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Chicago, Illinois, Spojené státy, 60637
- Aktivní, ne nábor
- University of Chicago Medical Center, Biological Science Division
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Harvey, Illinois, Spojené státy, 60426
- Nábor
- University of Chicago Ingalls Memorial Hospital
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Kontakt:
- Madeline Perez, B.S
- Telefonní číslo: 773-712-9178
- E-mail: maddieg@bsd.uchicago.edu
-
Dílčí vyšetřovatel:
- Carolyn Shima, PhD
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Vrchní vyšetřovatel:
- Sarah Keedy, PhD
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Dílčí vyšetřovatel:
- Molly Erickson, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depressive disorder with psychotic features, schizophreniform disorder, or psychosis NOS
- The diagnosis of one of the psychotic disorders has a duration of less than two years.
- Able to read, speak, and understand English, which will be assessed through observation.
- Able and willing to provide written informed consent or assent, in cases where caregivers are considered legal guardians. Dr. Shima, co-I of the study, is a forensic psychiatrist, and particularly adept at judging such ability. Drs. Erickson and Keedy have conducted studies in individuals with psychotic disorders, including FEP and in the context of clinical trials, for years, and are similarly competent to judge whether individuals can provide informed consent. Finally, we will also use an Evaluation to Sign Consent form that documents subjects' verbalized understanding of key aspects of the study.
- have an estimated IQ of > 65, assessed by the Wechsler Test of Adult Reading
- Eligible caregivers/proxy informants must be identified by the participant or clinical team as being involved in the participant's discharge planning or follow-up care, be able to provide informed verbal consent, and be able to speak and read English sufficiently to complete study questionnaires. Caregivers may include family members, close supports, or legally authorized representatives.
Exclusion Criteria:
- Individuals with substance-induced psychosis or psychosis due to a medical condition will not be included in the study. We will use the Structured Clinical Interview for DSM-5 as well as medical records, and if the subject gives permission, caregiver information in this process
- Individuals who do not meet criteria for a first episode of psychosis
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Individuals with First Episode Psychosis
Adults ages 18-40 admitted o an inpatient psychiatric unit with a first episode of psychosis (onset within prior 2 years) who received the Transition Care Team (TCT-FEP) intervention from hospitalization through to 6 weeks post-discharge
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The novel intervention is the Transition Care Team (TCT), a multidisciplinary clinical support model designed to improve continuity of care for individuals experiencing a first episode of psychosis.
The TCT provides short-term post-discharge services, including psychoeducation, case management, peer support, and coordination with outpatient programs until participants are established in Coordinated Specialty Care (CSC).
This differs from standard care, where patients typically receive discharge referrals without structured follow-up.
The intervention itself uses evidence-based clinical practices but applies them in a new, transitional format for this population, which is not currently part of standard inpatient-to-outpatient care at UChicago or Ingalls.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Effectiveness of Transition Care Team for First Episode Psychosis
Časové okno: 6 weeks post-discharge
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Attendance at 1 or more than 1 CSC appointment within 6 weeks of discharge
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6 weeks post-discharge
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Demographic Factors affecting CSC Engagement
Časové okno: From enrollment to the end of intervention at 6 week follow up
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Assessing mechanisms underlying effectiveness of CSC engagement by dividing subjects into those that did attend CSC and those that did not and compare the demographic [sex, age, socioeconomic status] data of patients.
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From enrollment to the end of intervention at 6 week follow up
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Symptom Severity/BPRS Score
Časové okno: From enrollment to the 6 week timepoint.
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Assessing mechanisms underlying the effectiveness of CSC engagement by dividing subjects into those that did attend CSC and those that did not attend and compare the symptom severity (BPRS score) at the patient-level.
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From enrollment to the 6 week timepoint.
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Barriers to Engagement
Časové okno: From the baseline to 6 week timepoint.
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Assessing mechanisms underlying effectiveness of CSC engagement by dividing subjects into those that did attend CSC and those that did not attend and compare the needs (family support) and system-level variables including transportation, insurance, etc. that are barriers that can affect attendance.
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From the baseline to 6 week timepoint.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Molly Erickson, PhD, University of Chicago
- Vrchní vyšetřovatel: Carolyn Shima, PhD, University of Chicago
- Vrchní vyšetřovatel: Sarah Keedy, PhD, University of Chicago
Publikace a užitečné odkazy
Obecné publikace
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Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB25-1866
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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