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）：基于德克萨斯州和宾夕法尼亚州的试点工作，创新治疗试点研究合作 R34 申请的目的是为自我指导的多地点 III 期临床试验做准备针对严重精神疾病 (SMI) 患者的护理 (SDC) 干预。在 SDC 中，参与者管理个人预算，用于购买商品和服务，包括特定类型的医疗保健、社会支持以及使他们能够独立生活的物品。由于分配给参与者的资金数额等于在传统计划中为他们提供服务所花费的数额，因此该方法被设计为“预算中性”。一项针对老年和残疾医疗补助受益人的三州随机对照试验的证据发现，与平常的服务相比，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，这种方法对 SMI 患者的使用仍然有限。经他们同意，两个地点各 88 名受试者将被随机分配到 SDC 或照常接受服务，并进行为期 12 个月的随访。 SDC参与者将被帮助制定以人为本的恢复计划和相应的预算。预算获得批准后，参与者将使用预算资金购买心理健康及其他服务和支持。主要成果将是症状减轻、功能增强和未满足需求的减少，次要成果是康复和行为激活以实现健康和精神疾病的自我管理。该研究有四个目标。第一个目标是开发和完善 SDC 干预实施手册以及忠诚度评估工具和程序，以衡量员工对模型的遵守情况。第二个目标是对 SDC 干预的有效性进行小型随机试点测试，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，测试不同研究条件下服务满意度的差异，并确定分配给这两种条件的人员中研究流失的原因。第四个目标是检验当地心理的有效性、可靠性和适用性。 卫生当局管理数据用于未来 R01 研究的利用率和成本分析。为了指导这项多地点研究，将成立一个由八名成员组成的项目指导委员会，由每个地点的首席研究员、项目总监、当地精神卫生机构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、忠实监督以及出版政策的制定。两个站点都可以访问该项目的去识别化跨站点数据库，并将使用相同的分析工具来协调应用分层、混合效应多变量统计模型。