跳至主要内容
临床试验/NCT04247711
NCT04247711招募中不适用

On Track Chile For First Episode Psychosis

University of Chile2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
Change on Adoption of OTCH among patients using the CollaboRATE

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

A two-fold strategy will be used to keep the blind. First, external interviewers with experience in conducting clinical evaluations will be hired and trained. These interviewers will be blind to study hypotheses and participant assignment. A mental health professional at each clinic (ie., "Local Coordinator") will do the consent procedures and a member of the Research Staff (ie., "Registration Designee") will randomly assign consented participants to the interviewers. The latter will be blinded to treatment allocation. Second, every assessment will be conducted at a location different from the clinic where a participant receives treatment. This location could be the participant's home, an office in UOH or UCH, or any place in the community where the participant feels comfortable (e.g., a park). This approach was successfully used in a previous U-19 study led by this research team in which most of the follow-up assessments were conducted in participants' neighborhoods.

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change on Adoption of OTCH among patients using the CollaboRATE

时间窗: baseline, 12 months, 24 months

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.

Change on Providers' attitudes using the Evidence-Based Practice Attitude Scale

时间窗: baseline, 12 months, 24 months

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.

Adapted version of the OTNY Fidelity Scale

时间窗: 24 months

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.

Change on Adoption of OTCH among providers using the Shared Decision Making Questionnaire Physician Version

时间窗: baseline, 12 months, 24 months

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.

Change on Adoption of OTCH among both patients and providers using the Recovery Self-Assessment scale

时间窗: baseline, 12 months, 24 months

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.

次要结局

  • Change on Social and Occupational Functioning(baseline, 12 months, 24 months)
  • Change on Psychotic symptoms(baseline, 12 months, 24 months)
  • Change on Medication adherence(baseline, 12 months, 24 months)
  • Change on Retention(baseline, 12 months, 24 months)
  • Change on Recovery Orientation(baseline, 12 months, 24 months)
  • Change on Patient-centeredness(baseline, 12 months, 24 months)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rubén Alvarado

Associate Professor

University of Chile

研究点 (2)

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