Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 12
- 主要终点
- Annualized hospitalization rates
研究概览
简要总结
The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.
详细描述
160 subjects will be randomized into a 12 month study, to one of two treatment arms. The investigators will assess four important elements of engagement to determine which are most sensitive to TH treatment and mediates effects on hospitalization rates. The investigators will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a training manual for implementing TH in CSC clinics and for use in future research. Although this study has exploratory aims consistent with pilot projects, The investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials.
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
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 16 and 35 years of age
- •Able to give informed consent
- •Willing and able to adhere to the study schedule
- •New intakes enrolled in one of the six clinical programs
- •Non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major depression with psychotic features, bipolar disorder with psychotic features) psychotic disorders with onsets within 5 years of enrollment.
排除标准
- •1. Known IQ < 70 based on participant report
结局指标
主要结局
Annualized hospitalization rates
时间窗: 12 months
To determine if CSC-TH, as compared to CSC-SD, is associated with superior clinical outcomes by counting the number of hospitalizations in a year
次要结局
- Number of participants hospitalized(12 months)
- Time (days) to first hospitalization(12 months)
- Number of participants hospitalized(12 months)
- Time (days) to first hospitalization(12 months)
- Symptom outcomes assessed by the Modified Colorado Symptom Index (MCSI)(12 months)
- Symptom outcomes assessed by the COMPASS-10(12 months)
- Functioning outcomes assessed by the MIRECC-GAF(12 months)
研究者
Alan Breier
Raymond E. Houk Professor of Psychiatry
Indiana University