NCT04247711

On Track Chile For First Episode Psychosis

Status unknown NA Last updated 18 June 2023

What this trial tests

NA trial testing OTCH in Psychosis in 300 participants. Status unknown.

Timeline

25 March 2021

Primary endpoint
30 March 2024

30 March 2025

Quick facts

Lead sponsor	University of Chile
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	300
Start date	25 March 2021
Primary completion	30 March 2024
Estimated completion	30 March 2025
Sites	1 location across Chile

Drugs / interventions tested

• OTCH
• Usual FEP Services

Conditions studied

• Psychosis — all drugs for Psychosis →

Sponsor

University of Chile

Who can join

Adults 15 to 35, any sex, with Psychosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial.
   Mascayano F, Bello I, Andrews H, Arancibia D, et al · · 2022 · cited 5× · PMID 36064643 · DOI 10.1186/s13063-022-06661-7
2. OnTrack Chile for People With Early Psychosis: a Study Protocol for a Hybrid Type 1 Trial
   Mascayano F, Bello I, Andrews H, Arancibia D, et al · · 2021 · DOI 10.21203/rs.3.rs-350678/v1