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

严重精神疾病患者自我导向护理的 1/2 多中心研究

• 批准号: 8702352
• 负责人: JUDITH A COOK
• 金额: $ 27.61万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8702352
• 关键词: Adherence; Adopted; Adult; Advocacy; Agreement; Behavioral; Budgets; Caring; Charge; Client; Clinical; Clinical Trials; Collaborations; Consent; Cost Analysis; Counseling; Data; Data Analyses; Databases; Development; Disabled Persons; Effectiveness; Elderly; Elements; Enrollment; Expenditure; Feasibility Studies; Frail Elderly; Funding; Funding Mechanisms; Future; Grant; Health; Health Services; Healthcare; Individual; Intervention; Intervention Studies; Knowledge; Life; Location; Manuals; Measures; Medicaid; Mental Health; Mental Health Services; Mental disorders; Methods; Modeling; Monitor; Outcome; Participant; Patients; Phase; Phase III Clinical Trials; Pilot Projects; Policies; Population; Preparation; Principal Investigator; Procedures; Protocols documentation; Public Health; Publications; Randomized; Randomized Controlled Trials; Recovery; Reporting; Research; Research Training; Role; Self Management; Services; Severities; Site; Site Visit; Social support; Staging; Statistical Models; Statutes and Laws; Symptoms; System; Teleconferences; Testing; Time; Validity and Reliability; Work; authority; base; beneficiary; cost; design; disability; empowerment; health care cost/financing; improved; innovation; instrument; meetings; member; novel; novel strategies; person centered; primary outcome; programs; psychosocial; public health relevance; randomized trial; response; satisfaction; secondary outcome; severe mental illness; staff intervention; tool; treatment as usual; uptake

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.

描述（由申请人提供）：基于TX和PA州的试验工作，该协作R34用于创新治疗申请的试点研究的目的是为患有严重精神疾病的人（SMI）进行自我指导的护理（SDC）干预的多站点III期临床试验（SMI）。在SDC中，参与者管理个人预算，他们从中购买商品和服务，包括特定类型的医疗保健，社会支持以及使他们独立生活的项目。由于分配的参与者的金额等于在传统计划中为他们服务的金额，因此该方法被设计为“预算中立”。来自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，与往常一样，SDC参与者的健康成果更好，对服务的满意度更高，而未满足的需求更少。然而，尽管有这些令人信服的证据，但对SMI患者使用这种方法仍然有限。在他们的同意下，在两个站点中的每个站点中的每个受试者都将随机分配给SDC或照常服务，然后持续十二个月。 SDC参与者将获得以人为本的恢复计划和相应的预算。经过预算的批准，参与者将使用预算资金购买心理健康以及其他服务和支持。主要结果将是减轻症状，功能增强和减少未满足的需求，以及用于自我管理健康和精神疾病的恢复和行为激活的次要结果。该研究有四个目标。第一个目的是开发和完善SDC干预实施手册，以及忠实评估工具和程序，以衡量员工对模型的遵守。第二个目的是对SDC干预的有效性进行小型随机试验测试，以评估所有研究程序。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差异，并确定分配给两种情况的人的研究损耗的原因。第四个目的是检查当地精神的有效性，可靠性和适用性 卫生当局的行政数据用于利用和成本分析，用于未来的R01研究。为了指导这项多站点研究，将组成一个由八人组成的项目指导委员会组成，该委员会由每个站点的首席研究员，项目总监，地方精神卫生局代表和消费者顾问组成。该委员会将被指控科学整合研究程序，研究和干预人员的培训，菲德利特监控以及发布政策的制定。这两个站点均可访问该项目的取消识别跨站点数据库，并将在协调的层次结构效果多变量统计模型的应用中使用相同的分析工具。