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临床试验/NCT03582813
NCT03582813已完成不适用

Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas

University of Illinois at Chicago0 个研究点目标入组 216 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
216
主要终点
Recovery From Mental Illness

研究概览

简要总结

Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness.

详细描述

Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness. Adults with serious mental illness served in the Texas public health system will be randomly assigned to SDC versus services as usual and assessed at baseline, 12-month, and 24-month follow-up. Mixed effects random-regression analysis will test for longitudinal changes in outcomes between the two study conditions. Differences in service costs will be analyzed using generalized linear models with negative binomial and zero-inflated negative binomial distribution. Non-traditional expenditures by the SDC participants will be examined descriptively. Service satisfaction in both study conditions will be assessed at one- and two-year follow-up.

研究设计

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

盲法说明

Research interviewers were blinded to study condition

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receiving mental health services at a Texas Department of State Health Services-funded mental health program
  • diagnosis of serious mental illness consistent with federal Public Law 102-32
  • assigned to a level of care eligible for a package of comprehensive clinical and rehabilitation services known as Service Package 3
  • 18 years or older
  • able to understand spoken English.

排除标准

  • cognitive impairment
  • homeless at time of recruitment
  • history of violent behavior resulting in arrest and conviction in the past 10 years
  • active substance use in the absence of substance use treatment
  • enrollment in Medicare or dual beneficiary
  • finances controlled by a third party (e.g., representative payee)

结局指标

主要结局

Recovery From Mental Illness

时间窗: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree". The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms.

次要结局

  • Perceived Autonomy Support(Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention))
  • Number of Participants With Employment(Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention))
  • Coping Mastery(Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention))
  • Number of Participants Enrolled in Classes(Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention))
  • Change in Mental Health Service Cost(First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation)
  • Change in Self-esteem(Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith A. Cook

Professor of Psychiatry

University of Illinois at Chicago

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