Academic-Community EPINET (AC-EPINET)

Study Overview
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Brief Summary
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The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.

Detailed Description
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180 subjects will be randomized into a 12 month study, to one of two treatment arms. The investigators will assess four important elements of engagement to determine which are most sensitive to TH treatment and mediates effects on hospitalization rates. The investigators will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a training manual for implementing TH in CSC clinics and for use in future research. Although this study has exploratory aims consistent with pilot projects, The investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials.

Official Title
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Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT

Conditions
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Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Major Depression With Psychotic Features, Bipolar Disorder With Psychotic Features

Intervention / Treatment
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* Other: Coordinated Specialty Care (CSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 16 and 35 years of age Able to give informed consent Willing and able to adhere to the study schedule New intakes enrolled in one of the six clinical programs Non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major depression with psychotic features, bipolar disorder with psychotic features) psychotic disorders with onsets within 5 years of enrollment. Exclusion Criteria: 1. Known IQ < 70 based on participant report

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CSC-SD<br>Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months. | Other: Coordinated Specialty Care (CSC)<br>* CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders<br>|
| Experimental: CSC-TH<br>Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months. | Other: Coordinated Specialty Care (CSC)<br>* CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized hospitalization rates | To determine if CSC-TH, as compared to CSC-SD, is associated with superior clinical outcomes by counting the number of hospitalizations in a year | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants hospitalized | Count of the number of participants hospitalized (adjusted for time in treatment) | 12 months | 
| Time (days) to first hospitalization | Count of the time in days to first hospitalization | 12 months | 
| Symptom and functioning outcomes assessed by the MIRECC-GAF | The MIRECC GAF is a three scale assessment of symptom severity, occupational/school functioning, and social functioning. It is scored from 0-100, with a lower score representing worse symptoms/functioning and higher scores representing better functioning. This assessment has been found to have high levels of reliability, concurrent, and predictive validity. It is completed by a trained rater and is expected to take 5 minutes to complete, as the information needed to score the participants will be gathered in various aspects of the assessment process. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosis