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

描述（由申请人提供）： 指导性问题是早期干预是否可以改善美国精神病患者的长期预后。我们假设，在公共精神卫生诊所提供的专门的多组分干预比常规护理更有效，也更具成本效益。尽管国外有证据支持早期干预服务，但其在美国医疗保健系统中的可行性和成本效益仍存在很大的不确定性。这项研究的数据将是至关重要的，在通知服务改革和卫生政策，针对严重的精神疾病在这个国家。核心设计特征是一项务实的随机对照试验，旨在比较专业的多组分或“STEP”护理与在精神障碍早期具有临床意义的人群中的常规治疗。将在临床状态、功能状态和成本方面跟踪结果。三年研究期间的住院率将作为主要结局。结果将在三个广泛的领域进行测量：1）临床状态：包括住院率和复发率，自杀倾向和症状量表; 2）功能状态：包括工作或参加适龄学校教育的能力，社会功能和生活质量; 3）成本：广泛测量，包括治疗和所使用的社会和法医服务的成本。通过随机分配比较的两种干预措施是：（a）由专业团队提供的护理，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性化病例管理;（B）在社区常规转诊治疗。对于二分数据，分析将采用Fisher精确检验和逻辑回归。将在基线时比较随机分组，并将显著差异输入逻辑回归分析。将使用考克斯回归模型分析至事件发生时间数据，例如至随机化后首次新住院的时间。将使用混合回归重复测量模型分析连续测量。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、监禁等）发生率的资料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，或所使用资源的实际成本，而不是预算成本或费用。在美国，精神病在常规护理下是常见的、致残的和昂贵的。在精神病发作后早期提供全面的治疗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项目旨在检验这样一种假设，即与通常的护理模式相比，这种早期护理具有成本效益，并将为患有这些常见疾病的个人提供护理。

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.