OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial.
OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial.
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OnTrack Chile 针对早期精神病患者：一项混合 1 型试验的研究方案。
作者：
来自高收入国家的大量数据支持以循证协调专业护理（CSC）形式对患有首发精神病（FEP）的人进行早期干预，以改善症状并最大限度地减少残疾。智利在拉丁美洲国家中是独一无二的，它通过一项全国性的家庭暴力和环境保护政策提供普遍获得家庭暴力和环境保护服务的机会，该政策规定在初级保健中确定家庭暴力和环境保护个人，并保证在公共保健系统内提供基于社区的家庭暴力和环境保护治疗。尽管如此，以前的研究已经证明，目前在精神卫生诊所提供的FEP服务并不提供循证方法。该提案旨在解决这一不足，首先调整OnTrackNY（OTNY），目前正在美国各地实施的CSC计划，进入OnTrackChile（OTCH），然后检查其有效性和在智利的实施情况。动态适应过程将首先用于告知OTCH的适应和实施，以适应智利的情况。然后，混合1型试验设计将测试其有效性和成本，并使用群集随机对照试验（RCT）（来自21个门诊诊所的N = 300）评估其实施情况。OTCH计划将在这些门诊诊所中的一半提供给15-35岁的个人。其他诊所将继续提供精神护理服务。鉴于目前的COVID-19大流行，大多数研究和干预程序将远程进行。该研究将在2年的时间内招募参与者，并在入组、12个月和24个月时进行评估。主要成果包括实施（忠诚度，可接受性和吸收）和服务成果（以人为本，坚持和保留）。次要结果包括参与者水平的结果，如症状，功能和恢复方向。在研究过程中，将与利益相关者进行访谈和焦点小组讨论，以更好地了解OTCH的实施情况。这项研究的结果将有助于确定在智利提供CSC服务的可行性，有效性和成本。在实施该模式的促进者和障碍方面吸取的经验教训可有助于为在整个拉丁美洲进一步扩大这些服务所需的方法提供信息。www.ClinicalTrials.govNCT04247711.于2020年1月30日注册。OTCH试验目前正在招募参与者。招募工作于2021年3月1日开始，预计于2022年12月1日完成。这是本方案的第一版（2021年5月12日）。
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 the 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 USA, into OnTrackChile (OTCH), and then examine its effectiveness and implementation in Chile. 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 2 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. 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. www.ClinicalTrials.govNCT04247711. Registered 30 January 2020. The OTCH trial is currently recruiting participants. Recruitment started on March 1, 2021, and is expected to be completed by December 1, 2022. This is the first version of this protocol (5/12/2021).
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DOI：
10.1176/appi.ps.201500438
发表时间：
2016-12-01
期刊：
Psychiatric services (Washington, D.C.)
影响因子：
--
作者：
Kreyenbuhl JA;Medoff DR;McEvoy JP;Smith TE;Hackman AL;Nossel IR;Dixon LB;Essock SM;Buchanan RW
通讯作者：
Buchanan RW
DOI：
10.1023/b:mhsr.0000024351.12294.65
发表时间：
2004-06-01
期刊：
Mental health services research
影响因子：
--
作者：
Aarons, Gregory A
通讯作者：
Aarons, Gregory A
影响因子：
8.2
作者：
Fritz, Matthew S.;MacKinnon, David P.
通讯作者：
MacKinnon, David P.
影响因子：
4.5
作者：
Byerly, Matthew J.;Nakonezny, Paul A.;Rush, A. John
通讯作者：
Rush, A. John
DOI：
10.1186/1748-5908-7-32
发表时间：
2012-04-18
期刊：
Implementation science : IS
影响因子：
--
作者：
Aarons GA;Green AE;Palinkas LA;Self-Brown S;Whitaker DJ;Lutzker JR;Silovsky JF;Hecht DB;Chaffin MJ
通讯作者：
Chaffin MJ