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，本创新治疗应用试点研究合作R34的目的是为严重精神疾病（SMI）患者的自我指导护理（SDC）干预的多中心III期临床试验做准备。在SDC中，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，社会支持和使他们能够独立生活的物品。因为分配给参与者的钱等于在传统项目中为他们服务的钱，所以这种方法被设计成“预算中立”。“一项针对老年人和残疾医疗补助受益人的三州随机对照试验的证据发现，与往常的服务相比，SDC参与者的健康状况更好，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，但这种方法在SMI患者中的应用仍然有限。在征得同意后，两个研究中心各有88名受试者将被随机分配至SDC或常规服务，并随访12个月。SDC参与者将得到帮助，以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轻，功能增强，减少未满足的需求，次要结果是恢复和行为激活，以自我管理健康和精神疾病。这项研究有四个目标。第一个目标是制定和完善可持续发展委员会干预措施实施手册以及忠诚度评估工具和程序，以衡量工作人员遵守该模式的情况。第二个目的是进行一个小型的随机试点测试的有效性的SDC干预，以评估所有的研究程序。第三个目的是评估SDC干预的可接受性，测试研究条件下的服务满意度的差异，并确定那些分配到两个条件之间的研究损耗的原因。第四个目的是检验本地心理测量的效度、信度和适用性。 用于未来R01研究的利用率和成本分析的卫生当局管理数据。为了指导这项多中心研究，将成立一个由八名成员组成的项目指导委员会，由每个中心的主要研究者、项目主任、当地精神卫生当局代表和消费者顾问组成。该委员会将负责研究程序的科学整合、研究和干预人员的培训、研究监测和出版政策的制定。两个研究中心都可以访问项目的去识别跨研究中心数据库，并将在分层、混合效应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.