Transition Care for FEP

Официальное название

Adapting and Improving Transition Care for First Episode Psychosis

Обзор

This study is testing a new approach to help people with first episode psychosis transition successfully from the hospital to outpatient mental health care. Many patients lose contact with services after they leave the hospital, which can lead to worse outcomes. The investigators have developed a Transition Care Team (TCT) that works with patients while they are in the hospital and continues to support them after discharge. The team provides therapy, case management, and coordination with community programs that offer ongoing care. The main goal of the study is to find out if this new program increases the number of patients who successfully begin outpatient treatment after hospitalization, compared to usual care. The investigators will also look at whether the program improves symptoms, functioning, and overall well-being.

Подробное описание

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.

Вмешательства

• Поведенческое Transition Care Team
  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

Первичные конечные точки

• Effectiveness of Transition Care Team for First Episode Psychosis [Срок оценки: 6 weeks post-discharge]

Вторичные конечные точки (3)

• Demographic Factors affecting CSC Engagement [Срок оценки: From enrollment to the end of intervention at 6 week follow up]
• Symptom Severity/BPRS Score [Срок оценки: From enrollment to the 6 week timepoint.]
• Barriers to Engagement [Срок оценки: From the baseline to 6 week timepoint.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 2 центра

• University of Chicago Medical Center, Biological Science Division — Chicago
• University of Chicago Ingalls Memorial Hospital — Harvey

Публикации

• Ma CF, Chan SKW, Chung YL, Ng SM, Hui CLM, Suen YN, Chen EYH. The predictive power of expressed emotion and its components in relapse of schizophrenia: a meta-analysis and meta-regression. Psychol Med. 2021 Feb;51(3):365-375. doi: 10.1017/S0033291721000209. Epub 2021 Feb 11. PMID 33568244
• Keegan C, Brown K, Gaynor K. A Systematic Review Exploring the Relationship Between Family Factors and Symptom Severity, Relapse and Social or Occupational Functioning in First-Episode Psychosis. Early Interv Psychiatry. 2025 Mar;19(3):e13643. doi: 10.1111/eip.13643. Epub 2025 Jan 8. PMID 39779465
• Villagonzalo KA, Leitan N, Farhall J, Foley F, McLeod B, Thomas N. Development and validation of a scale for self-efficacy for personal recovery in persisting mental illness. Psychiatry Res. 2018 Nov;269:354-360. doi: 10.1016/j.psychres.2018.08.093. Epub 2018 Aug 25. PMID 30173041
• Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM. Assessment of insight in psychosis. Am J Psychiatry. 1993 Jun;150(6):873-9. doi: 10.1176/ajp.150.6.873. PMID 8494061
• Schneider LC, Struening EL. SLOF: a behavioral rating scale for assessing the mentally ill. Soc Work Res Abstr. 1983 Fall;19(3):9-21. doi: 10.1093/swra/19.3.9. PMID 10264257
• Humensky JL, Bello I, Malinovsky I, Nossel I, Patel S, Jones G, Cabassa LJ, Radigan M, Sobeih T, Tobey C, Basaraba C, Scodes J, Smith T, Wall M, Labouliere C, Stanley B, Dixon LB. OnTrackNY's learning healthcare system. J Clin Transl Sci. 2020 Apr 6;4(4):301-306. doi: 10.1017/cts.2020.35. PMID 33244410
• Vohs JL, Srihari V, Vinson AH, Lapidos A, Cahill J, Taylor SF, Heckers S, Weiss A, Chaudhry S, Silverstein S, Tso IF, Breitborde NJK, Breier A. The Academic Community Early Psychosis Intervention Network: Toward building a novel learning health system across six US states. Learn Health Syst. 2024 Nov 17;9(2):e10471. doi: 10.1002/lrh2.10471. eCollection 2025 Apr. PMID 40247900
• Tryon VL, Nye KE, Savill M, Loewy R, Miles MJ, Tully LM, Padovani AJ, Tancredi DJ, Melnikow J, Ereshefsky S, Sharma N, McNamara AP, Kado-Walton M, Hakusui CK, Miller C, Nguyen KLH, Safdar M, Padilla VE, Smith L, Wilcox AB, Banks LM, Hayes SL, Pierce KM, Muro K, Shapiro DI, Bolden-Thompson KA, Botello RM, Grattan RE, Zhang Y, Hotz B, Dixon L, Carter CS, Niendam TA. The California collaborative netw PMID 39543502

Идентификаторы

NCT: NCT07713849 · IRB25-1866

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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