1/2-Multisite Study of Self-Directed Care for People with Serious Mental Illness

描述(由申请人提供)：基于德克萨斯州和宾夕法尼亚州的试点工作，这项创新治疗试点研究协作R34应用程序的目的是为严重精神疾病(SMI)患者的自我指导护理(SDC)干预的多地点第三阶段临床试验做准备。在SDC，参与者管理个人预算，从中购买商品和服务，包括特定类型的医疗保健、社会支持和允许他们独立生活的物品。由于参与者被分配的金额与在传统项目中为他们提供服务所花费的金额相同，因此这种方法被设计为“预算中立”。一项对老年和残疾医疗补助受益人进行的三州随机对照试验的证据发现，与通常的服务相比，SDC参与者的健康结果更好，对服务的满意度更高，未满足的需求更少。然而，尽管有这些令人信服的证据，这种方法在SMI患者中的使用一直受到限制。如果得到他们的同意，两个地点的88名受试者将被随机分配到SDC或照常接受服务，并接受为期12个月的跟踪调查。将帮助SDC参与者制定以人为本的恢复计划和相应的预算。一旦预算获得批准，参与者将使用预算资金购买心理健康和其他服务和支持。主要结果将是症状减少、功能增强和未得到满足的需求减少，其次是康复和自我管理健康和精神疾病的行为激活。这项研究有四个目标。第一个目标是制定和完善一份SDC干预实施手册以及一份忠诚度评估工具和程序，以衡量工作人员遵守这一模式的情况。第二个目标是对SDC干预的有效性进行一次小型随机试点试验，以评估所有研究程序。第三个目标是评估SDC干预的可接受性，通过研究条件测试服务满意度的差异，并确定分配到两种条件下的研究损耗的原因。第四个目标是检验本地心理测验的效度、信度和适宜性 卫生当局管理数据，用于未来R01研究的利用和成本分析。为了指导这项多站点研究，将成立一个由八名成员组成的项目指导委员会，成员包括每个站点的首席调查员、项目总监、当地精神卫生当局代表和消费者顾问。该委员会将负责研究程序的科学整合、研究和干预工作人员的培训、忠诚度监测以及出版政策的制定。这两个站点将能够使用该项目已确定的跨站点数据库，并将在分层、混合效果多变量统计模型的协调应用中使用相同的分析工具。

DESCRIPTION (provided by applicant): Based on pilot work in the states of TX and PA, the purpose of this Collaborative R34 for Pilot Studies of Innovative Treatments application is to prepare for a multi-site, Phase III clinical trial of a Self-Directed Care (SDC) intervention for people with serious mental illness (SMI). In SDC, participants manage a personal budget from which they purchase goods and services including specific types of health care, social supports, and items that allow them to live independently. Because the amount of money that participants are allocated is equal to the amount that would have been spent on serving them in traditional programs, the approach is designed to be "budget neutral." Evidence from a three-state randomized controlled trial with elderly and disabled Medicaid beneficiaries found that, compared to services as usual, SDC participants had better health outcomes, higher satisfaction with services, and fewer unmet needs. Yet despite this compelling evidence, use of this approach for people with SMI has been limited. With their consent, 88 subjects at each of the two sites will be randomly assigned to SDC or to services as usual and followed for twelve months. SDC participants will be helped to develop a person-centered recovery plan and corresponding budget. Upon approval of their budget, participants will use budgeted funds to purchase mental health and other services and supports. The primary outcomes will be symptom reduction, enhanced functioning, and reduction of unmet needs, with secondary outcomes of recovery and behavioral activation for self-management of health and mental illness. The study has four aims. The first aim is to develop and refine an SDC intervention implementation manual as well as a fidelity assessment instrument and procedures to measure staff's adherence to the model. The second aim is to conduct a small randomized pilot test of the effectiveness of the SDC intervention in order to evaluate all research procedures. The third aim is to assess SDC intervention acceptability, test for differences in service satisfaction by study condition, and determine reasons for study attrition among those assigned to both conditions. The fourth aim is to examine the validity, reliability, and suitability of local mental health authority administrative data for use in utilization and cost analyses for a future R01 study. To guide this multi-site study, an eight-member project Steering Committee will be formed, comprised of each site's Principal Investigator, Project Director, local mental health authority representative, and consumer consultant. The committee will be charged with the scientific integration of research procedures, training of research and intervention staff, fidelit monitoring, and development of a publication policy. Both sites will have access to the project's de-identified cross-site data base and will use the same analytic tools in a coordinated application of hierarchical, mixed-effects multivariable statistical models.