OnTrack Chile for People With Early Psychosis: a Study Protocol for a Hybrid Type 1 Trial

Abstract

Background: Substantial data from high-income countries support early interventions in the form of evidence-based Coordinated Specialty Care (CSC) for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. Chile is unique among Latin American countries in providing universal access to FEP services through a national FEP policy that mandates identification of FEP individuals in primary care and guarantees delivery of community-based FEP treatments within a public health care system. Nonetheless, previous research has documented that FEP services currently provided at mental health clinics do not provide evidence-based approaches. This proposal aims to address this shortfall by first adapting OnTrackNY (OTNY), a CSC program currently being implemented across the US, into OnTrackChile (OTCH), and then examine its effectiveness and implementation in Chile.Methods: The Dynamic Adaptation Process will be used first to inform the adaptation and implementation of OTCH to the Chilean context. Then, a Hybrid Type 1 Trial design will test its effectiveness and cost and evaluate its implementation using a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OTCH program will be offered in half of these outpatient clinics to individuals ages 15-35. Usual care services will continue to be offered at the other clinics. Given the current COVID-19 pandemic, most research and intervention procedures will be conducted remotely. The study will engage participants over the course of two years, with assessments administered at enrollment, 12 months and 24 months. Primary outcomes include: implementation (fidelity, acceptability, and uptake) and service outcomes (person-centeredness, adherence, and retention). Secondary outcomes comprise participant-level outcomes such as symptoms, functioning, and recovery orientation. Over the course of the study, interviews and focus groups with stakeholders will be conducted to better understand the implementation of OTCH. Discussion: Findings from this study will help determine the feasibility, effectiveness, and cost for delivering CSC services in Chile. Lessons learned about facilitators and barriers related to the implementation of the model could help inform the approach needed for these services to be further expanded throughout Latin America.Trial registration number: www.clinicaltrials.gov: NCT04247711. Registered 30 January 2020, https://clinicaltrials.gov/ct2/show/NCT04247711.

Stigma toward psychosis in urban Chile: Engaging “what matters most” to resist stigma through recovery-oriented services.

“…In this context, MHS seem effective in mitigating some but not all factors shaping stigmaoften helping enable employment, having a mixed effect on appearance and independence, and largely remaining insufficient for enabling marriage and having a family. These findings can help orient current efforts to further develop and tailor MHS in Chile (Mascayano et al, 2021), thereby fostering social reintegration.…”

“…Family can promote treatment adherence and support vocational and social rehabilitation through organizations (Stewart, 2004). For FEP, OnTrack-Chile encourages involving family members in psychoeducation and other aspects of treatment (e.g., shared decision-making; Mascayano et al, 2021).…”

“…MHS currently consist largely of pharmacologic treatment, with limited integration/ uptake of evidence-based psychosocial treatments in some centers. An ongoing trial (OnTrack-Chile) seeks to implement coordinated specialty care, including cognitive-behavioral therapy, family psychoeducation, and supported employment (Mascayano et al, 2021). As MHS expand, applying the WMM framework facilitates delineation of how MHS can further promote social inclusion of users.…”

“…Supported employment, not currently comprehensively available in Chile, can cost-effectively help users obtain and retain jobs that match their individual goals/preferences (Hoffmann et al, 2014). OnTrack-Chile aims to involve occupational therapists in connecting job-desiring users to resources facilitating employment (Mascayano et al, 2021).…”

Initial adaptation of the OnTrack coordinated specialty care model in Chile: An application of the Dynamic Adaptation Process

“…In line with the significant amount of positive outlook that the OnTrack model is receiving throughout the field (20), participants from all stakeholder groups generally perceived that the OnTrack model introduces a novel and aspirational framework of FEP care that has the potential to link patients and their families to early treatment to facilitate recovery. The multi-faceted approach of OnTrack, including its focus on recovery-oriented and patient-centered care, was considered crucial to treatment for users with FEP.…”