Transition Care for FEP (TCT FEP)

July 14, 2026 updated by: University of Chicago

Adapting and Improving Transition Care for First Episode Psychosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Madeline Perez Lab Manager, B.S
  • Phone Number: 773-712-9178
  • Email: keedylab@gmail.com

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago Medical Center, Biological Science Division
      • Harvey, Illinois, United States, 60426
        • Recruiting
        • University of Chicago Ingalls Memorial Hospital
        • Contact:
        • Sub-Investigator:
          • Carolyn Shima, PhD
        • Principal Investigator:
          • Sarah Keedy, PhD
        • Sub-Investigator:
          • Molly Erickson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from those admitted to the psychiatry units in the Wyman Gordon building at University of Chicago Ingalls Memorial hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Behavioral: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Transition Care Team for First Episode Psychosis
Time Frame: 6 weeks post-discharge
Attendance at 1 or more than 1 CSC appointment within 6 weeks of discharge
6 weeks post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Factors affecting CSC Engagement
Time Frame: From enrollment to the end of intervention at 6 week follow up
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.
From enrollment to the end of intervention at 6 week follow up
Symptom Severity/BPRS Score
Time Frame: From enrollment to the 6 week timepoint.
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.
From enrollment to the 6 week timepoint.
Barriers to Engagement
Time Frame: From the baseline to 6 week timepoint.
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.
From the baseline to 6 week timepoint.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Sidney R. Baer, Jr. Foundation

Investigators

  • Principal Investigator: Molly Erickson, PhD, University of Chicago
  • Principal Investigator: Carolyn Shima, PhD, University of Chicago
  • Principal Investigator: Sarah Keedy, PhD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2026

Primary Completion (Estimated)

May 6, 2028

Study Completion (Estimated)

May 6, 2029

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB25-1866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a pilot study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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