On Track Chile For First Episode Psychosis

Psychosis Clinical Trial

Official title:

On Track Chile For First Episode Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247711
• Other study ID #: R01MH115502-02
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2023
• Source: University of Chile
• Contact: Ruben Alvarado, MD PhD
• Phone: 562 2 903 0000
• Email: ralvarado[@]med.uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Substantial data support early interventions for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. FEP programs have been widely and successfully implemented in high-income countries. With the partial exception of Chile, however, there is not a single low-and-middle-income country (LMIC) that offers universal access to FEP services. Chile is unique among LMICs in having created a platform for the implementation of FEP services, including 1) an FEP policy that mandates identification of FEP individuals at primary care and delivery of community-based FEP treatments at outpatient mental health clinics, and 2) a public health care system within which this mandate can be fulfilled. Nonetheless, previous research has documented that FEP services provided at mental health clinics do not conform to recently established evidence-based approaches. Therefore, the overarching goal of this proposal is to address the shortfall in evidence-based practices for FEP in Chile by first adapting OnTrackChile (OTCH) from OnTrackNY (OTNY), a coordinated specialty care program for FEP currently being implemented across the US, and then implementing OTCH on a wide scale. Like most FEP programs, OTNY is clinically effective, but unlike most others, it also has a well-established training and technical assistance infrastructure, and a proven track record of being scaled up in large urban areas. To achieve this goal, the Dynamic Adaptation Process will be used to first inform the adaptation and implementation of OTCH in the Chilean context. Then, a Hybrid Trial design will be employed to evaluate the implementation of OTCH as well as its effectiveness and cost in a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OnTrackChile program will be offered in half of these outpatient clinics; usual care services will continue to be offered at the other clinics. Study participants (ages 15 to 35) attending an outpatient clinic assigned to the intervention arm will receive the OTCH coordinated services provided by an interdisciplinary team, based on the interests, needs, and preferences of each study participant. Study participants attending outpatient clinics assigned to "usual care" will receive the usual services offered to people with a wide range of mental health conditions, not just those experiencing first-episode psychosis. The study will engage participants over the course of two years, with interviews to evaluate their experiences at the beginning of their participation, and again after 12 months and 24 months. Over the course of the study, 4-5 mental health providers will also be interviewed at each of the participating clinics (up to 105 additional interviews at the three timepoints). The data collected in this study will help researchers evaluate the effectiveness and cost of FEP treatments based in outpatient clinics and factors which may help or hinder these outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Individuals who have FEP (First Episode Psychosis)

• Individuals who are receiving services at a participating outpatient mental health clinic.

• Individuals who meet ICT-10 criteria for a diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or psychosis not otherwise specified.

• Individuals who have the capacity to provide fully informed consent. (For those under age 18, capacity to provide assent plus informed consent of parent/guardian.)

• Individuals who are able to participate in research assessments in Spanish

Exclusion Criteria:

• Individuals who have a non-psychiatric medical condition that impairs functioning.

• Individuals who have a psychosis due solely to another medical condition.

• Individuals who have a psychosis due to a developmental disability.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• OTCH
OTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care.
• Usual FEP Services
These include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics.

Locations

Country	Name	City	State
Chile	CESAM San Joaquín	Santiago

Sponsors (7)

Lead Sponsor	Collaborator
University of Chile	Columbia University, New York State Psychiatric Institute, New York University, Research Foundation for Mental Hygiene, Inc., Universidad de O'Higgins, Washington University School of Medicine

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adapted version of the OTNY Fidelity Scale	This scale will assess the degree to which the participating clinics deliver OTCH. The scale 24 dimensions rated on a 3-score rating where 0=unmet, 1=partially met, and 2=totally met. Higher scores mean better Fidelity.	24 months
Primary	Change on Providers' attitudes using the Evidence-Based Practice Attitude Scale	Providers' attitudes to evidence-based practices will be measured by the evidence-based attitude scale (EBPAS). The EBPAS consists of 15 items rated on a five-point scale from 0=Not at all to 4=Very great extent. Higher scores mean better attitudes to evidence-based practices.	baseline, 12 months, 24 months
Primary	Change on Adoption of OTCH among patients using the CollaboRATE	This is a 3-item scale rated on a ten-point scale from 0=No effort was made to 9=Every effort was made. Higher scores mean better Adoption.	baseline, 12 months, 24 months
Primary	Change on Adoption of OTCH among providers using the Shared Decision Making Questionnaire Physician Version	This questionnaire continues with nine items about the steps in the adoption of the shared-decision making approach, one of the key components of OTCH. Each item is rated on a six-point scale from 0=Completely disagree to 5=Completely agree. Higher scores indicate more shared-decision making.	baseline, 12 months, 24 months
Primary	Change on Adoption of OTCH among both patients and providers using the Recovery Self-Assessment scale	This is a 32-item, self-administered rating scale that will measure perceptions about recovery principles and overall quality of services. Each item is rated on a five-point scale from 1=Strongly disagree to 5=Strongly agree. Higher scores indicate greater quality care.	baseline, 12 months, 24 months
Secondary	Change on Patient-centeredness	Measured by Youth Services Survey (YSS). Each item is rated on a five-point scale from 1=Strongly disagree to 5=Strongly agree. Higher scores mean more Patient-centeredness.	baseline, 12 months, 24 months
Secondary	Change on Medication adherence	Measured by the Brief Adherence Rating Scale (BARS). It consists of 4 items: 3 questions and an overall visual analog rating scale to assess the percentage of antipsychotic medication doses taken by the user in the past month (0%-100%).	baseline, 12 months, 24 months
Secondary	Change on Retention	Measured by the Service Utilization and Resources Form (SURF). Time remaining in treatment will be estimated by counting the number of days between randomization to the time of the last mental health service received measured by the SURF. Range: from 0 to 365 days over a 12 month period; from 0 to 730 days over a 24-month period.	baseline, 12 months, 24 months
Secondary	Change on Psychotic symptoms	Measured by Positive and Negative Syndrome Scale (PANSS). This scale will be used to assess positive and negative symptoms (only the first 14 items). The level of psychopathology is rated on a seven-point scale from 1=Absent to 7=Extreme. Higher scores mean worse symptomatology.	baseline, 12 months, 24 months
Secondary	Change on Social and Occupational Functioning	Measured by the Social and Role Functioning in Psychosis and Schizophrenia (SRFP) scale. This scale asks for social, behavioral, and occupational difficulties associated with mental illness, including psychosis and schizophrenia. Functioning is rated on an eleven-point scale from 0=Extreme role dysfunction to 10=Superior social/interpersonal functioning. Higher scores mean better social and occupational functioning.	baseline, 12 months, 24 months
Secondary	Change on Recovery Orientation	Measured by the Questionnaire about the Process of Recovery (QPR). This instrument has 15 items each scored on a four-point scale ranging from 0=Strongly disagree to 4=Strongly agree. A Higher scores indicate greater recovery.	baseline, 12 months, 24 months