Clinical trial NCT04247711: On Track Chile For First Episode Psychosis
Official title: On Track Chile For First Episode Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Keywords: First-Episode Psychosis
Implementation Science
Coordinated Specialty Care
Global Mental Health
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Universidad de O'Higgins
name: Columbia University
name: Washington University School of Medicine
name: New York University
name: Research Foundation for Mental Hygiene, Inc.
name: New York State Psychiatric Institute
First posted: 2020-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 21 participating clinics will be divided into two groups based on poverty level of catchment area and expected enrollment of individuals with FEP for each clinic. The largest site will be matched with two clinics of similar poverty level and clinic size. The matching will be done based on visual inspection of a scatter plot of expected enrollment by income of each site. The nearest neighbor matching approach will be used to choose pairs. Blocks of size 2, and one block of size 3, will be randomly generated. This procedure will entail 1) generating a random number 0 or 1 ten times, and 2) assigning 0 to the Usual FEP care clinic and 1 to the OTCH clinic in each matched pair. For the block of size 3, two sites will be assigned to either OTCH or Usual FEP care, and the remaining site to either OTCH or Usual FEP care as well. The random allocation will enable us to bring into the study one OTCH and one Usual FEP Care clinic per month (except for the block of size 3, as noted above).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adapted version of the OTNY Fidelity Scale
timeFrame: 24 months
measure: Change on Providers' attitudes using the Evidence-Based Practice Attitude Scale
timeFrame: baseline, 12 months, 24 months
measure: Change on Adoption of OTCH among patients using the CollaboRATE
timeFrame: baseline, 12 months, 24 months
measure: Change on Adoption of OTCH among providers using the Shared Decision Making Questionnaire Physician Version
timeFrame: baseline, 12 months, 24 months
measure: Change on Adoption of OTCH among both patients and providers using the Recovery Self-Assessment scale
timeFrame: baseline, 12 months, 24 months
Secondary outcomes:
measure: Change on Patient-centeredness
timeFrame: baseline, 12 months, 24 months
measure: Change on Medication adherence
timeFrame: baseline, 12 months, 24 months
measure: Change on Retention
timeFrame: baseline, 12 months, 24 months
measure: Change on Psychotic symptoms
timeFrame: baseline, 12 months, 24 months
measure: Change on Social and Occupational Functioning
timeFrame: baseline, 12 months, 24 months
measure: Change on Recovery Orientation
timeFrame: baseline, 12 months, 24 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CESAM San Joaquín
Study officials:
affiliation: University of Chile
name: Ruben Alvarado, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mascayano F, Bello I, Andrews H, Arancibia D, Arratia T, Burrone MS, Conover S, Fader K, Jorquera MJ, Gomez M, Malverde S, Martinez-Ales G, Ramirez J, Reginatto G, Restrepo-Henao A, Rosencheck RA, Schilling S, Smith TE, Soto-Brandt G, Tapia E, Tapia T, Velasco P, Wall MM, Yang LH, Cabassa LJ, Susser E, Dixon L, Alvarado R. OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial. Trials. 2022 Sep 5;23(1):751. doi: 10.1186/s13063-022-06661-7.