Specialized Treatment Early in Psychosis (STEP): A community health center based

描述(由申请人提供)： 引导性的问题是，早期干预是否可以改善美国精神病患者的长期结果。我们假设，在公共精神卫生诊所提供的专门的多成分干预将比常规护理更有效，也更具成本效益。尽管有证据支持国外的早期干预服务，但它在美国医疗体系中的可行性和成本效益仍然存在很大的不确定性。这项研究的数据将为该国针对严重精神疾病的服务改革和卫生政策提供信息。核心设计特征是一项务实的随机对照试验，该试验寻求在处于精神障碍早期的具有临床意义的个人群体中，将专门的多组分或“步骤”护理与常规治疗进行比较。结果将在临床状态、功能状态和成本领域进行跟踪。三年研究期间的住院率将作为主要结果。将在三个大的领域衡量结果：1)临床状况：包括住院率和复发、自杀和症状量表；2)功能状况：包括工作能力或上适龄学校、社会功能和生活质量；3)费用：广义衡量，包括治疗和使用的社会和法医服务的费用。通过随机分配比较的两种干预措施是：(A)由专门团队提供的护理，包括药物处方、认知行为治疗小组、家庭心理教育和侧重于职业和教育康复的个体化病例管理；(B)转诊至社区照常治疗。对于二分资料，分析将采用费舍尔精确检验和Logistic回归。随机组将在基线时进行比较，显著差异将进入Logistic回归分析。发生事件的时间数据，如随机后首次住院的时间，将使用COX回归模型进行分析。这种连续测量将使用混合回归重复测量模型进行分析。确定成本效益的基本方法将是收集与成本有关的事件(服务利用率、监禁等)发生情况的信息。使用既定和全面的工具，然后将这些事件乘以每个事件的估计平均单位成本。我们将估计经济成本，或实际使用的资源成本，而不是预算成本或费用。在美国，精神病是一种常见的致残疾病，在常规护理下成本高昂。提供全面的治疗，并在精神病发作后及早提供，有可能以具有成本效益的方式改善长期结果。精神病早期专门治疗(STEP)项目旨在检验这样一个假设，即与通常的护理模式相比，这种早期护理是具有成本效益的，并将为患有这些常见疾病的个人的护理提供信息。

DESCRIPTION (provided by applicant): The guiding question is whether early intervention can improve long term outcomes for psychotic disorders in the U.S. We hypothesize that a specialized multi-component intervention, delivered in a public mental health clinic will be more effective than usual care and also more cost effective. Despite evidence supporting early intervention services abroad, there remains significant uncertainty about its feasibility and cost-effectiveness in the U.S. healthcare system. Data from this study will be critical in informing both service reform and health policy targeting serious mental illness in this country. The core design feature is a pragmatic, randomized controlled trial that seeks to compare specialized multi-component or 'STEP' care to treatment as usual in a clinically meaningful population of individuals who are early in the course of a psychotic disorder. Outcomes will be followed in the domains of clinical status, functional status and costs. Rates of hospitalization over the three year study period will serve as the primary outcome. Outcomes will be measured in three broad domains: 1) clinical status: including hospitalization rate and relapse, suicidality and symptom scales; 2) functional status: including ability to work or attend age-appropriate schooling, social functioning and quality of life and 3) costs: broadly measured to include costs of treatment and social and forensic services used. The two interventions being compared by random assignment are (a) care delivered by a specialized team that includes the components of medication prescription, cognitive behavioral therapy groups, family psycho-education and individualized case management that is focused on vocational and educational rehabilitation versus (b) referral to treatment as usual in the community. For dichotomous data, the analysis will employ Fisher's exact tests and logistic regression. The randomized groups will be compared at baseline and significant differences will be entered into the logistic regression analysis. Time to event data, such a time to first new hospitalization after randomization, will be analyzed using Cox regression models. Continuous measures such will be analyzed using mixed regression repeated measures models. The basic method of determining cost-effectiveness will be to collect information on the incidence of cost-related events (service utilization, incarceration, etc.) using established and comprehensive instruments and then to multiply these events by the estimated mean unit cost for each event. We will estimate the economic costs, or the actual costs of resources used, rather than budget costs or fees. Psychotic illnesses are common, disabling and costly under usual care in the U.S. The provision of treatment that is comprehensive and delivered early after psychosis onset has the potential to improve long term outcomes in a cost-effective manner. The Specialized Treatment Early in Psychosis (STEP) project is designed to test the hypothesis that such early care is cost-effective in comparison to usual models of care and will inform the care of individuals who suffer from these common illnesses.