Improving Mental Health Outcomes: Buidling an Adaptive Implementation Strategy

改善心理健康结果：制定适应性实施策略

• 批准号: 8989477
• 负责人: AMY M KILBOURNE
• 金额: $ 57.1万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-15 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8989477
• 关键词: Address; Adopted; Adoption; Ambulatory Care Facilities; Arkansas; Awareness; Clinic; Clinical; Cluster randomized trial; Collaborations; Colorado; Communities; Community Practice; Community of Practice; Cost Effectiveness Analysis; Data; Effectiveness; Evidence based practice; Evolution; Exhibits; Exposure to; Goals; Health; Human Resources; Intervention; Leadership; Life; Measures; Mental Health; Mental disorders; Michigan; Mood Disorders; Outcome; Patient-Focused Outcomes; Patients; Persons; Provider; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Readiness; Reporting; Research; Research Design; Research Personnel; Research Priority; Resources; Role; Rural; Site; Staging; Symptoms; Technical Expertise; Time; Training; Translating; United States National Institutes of Health; base; cohort; community based practice; community based treatment; community setting; cost; cost effective; cost effectiveness; design; evidence base; implementation research; implementation trial; improved; improved outcome; innovation; novel; operation; primary outcome; programs; psychosocial; randomized trial; reduce symptoms; research to practice; response; routine care; routine practice; secondary outcome; tool; trial design; uptake

DESCRIPTION (provided by applicant): Despite the availability of psychosocial evidence-based practices (EBPs), quality and outcomes for persons with mental disorders remain suboptimal because of organizational barriers to implementation. Replicating Effective Programs (REP), an implementation intervention applied to promote the use of psychosocial treatments in community-based practices, still resulted in less than half of sites actually sustaining the use of these treatments. Based on input from community partners from our previous R01 (MH79994), the study team subsequently enhanced REP to include Facilitation, a novel implementation intervention which addresses site- level organizational barriers to EBP adoption beyond REP's emphasis on fidelity. Two Facilitation roles were developed: External and Internal Facilitators. External Facilitators (EFs) reside outside the clinic, are supported by the study, and provide technical expertise to providers in adapting and using EBPs in routine practice. Internal Facilitators (IFs) are employed by the sites, have a direct reporting relationshp to site leadership, and have protected time to conduct activities to help site program champions implement EBPs. IFs also address site-specific organizational barriers that may not be observable at baseline or by EFs. The overarching goal of this study is to build the most cost-effective adaptive implementation intervention involving REP and the augmentation of the EF and IF roles to improve patient outcomes and the uptake of an EBP for mood disorders (Life Goals-LG) in community settings. The primary aim of this clustered randomized trial is to determine, among sites not initially responding to REP (i.e., limited LG uptake), the effect of adaptive implementation interventions in sites receiving External and Internal Facilitator (REP+EF/IF) versus External Facilitator alone (REP+EF) on improved patient-level outcomes, including mental health quality of life and decreased symptoms, as well as increased LG use among patients with mood disorders after 12 months. Secondary aims are to determine, among sites that continue to exhibit non-response after 12 months, the effect of continuing Facilitation on patient-level outcomes at 24 months, describe the implementation of EF and IF, and to conduct a cost-effectiveness analysis of REP+EF/IF compared to REP+EF over the 24-month period. A representative cohort of 100 community-based outpatient clinics (total 1,600 patients) from different U.S. regions (Michigan, Colorado, and Arkansas) will be included in this study. We will use a Sequential Multiple Assignment Randomized Trial (SMART) design to build the best adaptive implementation intervention. This groundbreaking study design will address three crucial implementation issues: First, IFs are costly for sites since they require additional administrative effort. Second, the extent to which an off-site EF alone versus the addition of an on- site IF can improve patient outcomes in community settings is unclear. Finally, among sites that continue to exhibit non-response after 12 months of Facilitation, the value of continuing the implementation strategy (i.e., delayed effect) has not been assessed, especially in smaller practices from more rural settings.

描述（由申请人提供）：尽管有基于心理社会证据的实践（EBP），但由于实施的组织障碍，精神障碍患者的质量和结果仍然不理想。复制有效计划（REP）是一项实施干预措施，旨在促进在社区实践中使用心理社会治疗，但仍然只有不到一半的地点真正维持使用这些治疗。根据之前 R01 (MH79994) 中社区合作伙伴的意见，研究团队随后增强了 REP，将促进纳入其中，这是一种新颖的实施干预措施，除了 REP 强调的保真度之外，还解决了采用 EBP 的站点级组织障碍。制定了两种促进角色：外部促进者和内部促进者。外部促进者 (EF) 驻留在诊所外，得到研究的支持，并为提供者在日常实践中调整和使用 EBP 提供技术专业知识。内部协调员 (IF) 由站点雇用，与站点领导层有直接报告关系，并有充足的时间开展活动，帮助站点计划倡导者实施 EBP。 IF 还解决了基线或 EF 可能无法观察到的特定地点的组织障碍。本研究的总体目标是建立最具成本效益的适应性实施干预措施，涉及 REP 以及增强 EF 和 IF 的作用，以改善社区环境中患者的治疗结果和 EBP 治疗情绪障碍（生活目标-LG）的情况。这项集群随机试验的主要目的是确定，在最初没有对 REP 作出反应（即 LG 吸收有限）的场所中，接受外部和内部促进剂 (REP+EF/IF) 的场所与外部促进剂相比，适应性实施干预的效果单独使用（REP+EF）可以改善患者的预后，包括心理健康生活质量和症状减轻，以及 12 个月后情绪障碍患者增加 LG 的使用。次要目标是确定 12 个月后继续表现出无反应的站点中，持续促进对 24 个月时患者水平结果的影响，描述 EF 和 IF 的实施情况，并进行成本效益分析24 个月内 REP+EF/IF 与 REP+EF 的比较。本研究将包括来自美国不同地区（密歇根州、科罗拉多州和阿肯色州）的 100 个社区门诊诊所（总共 1,600 名患者）的代表性队列。我们将使用序贯多重分配随机试验 (SMART) 设计来构建最佳自适应实施干预措施。这项开创性的研究设计将解决三个关键的实施问题：首先，IF 对于站点来说成本高昂，因为它们需要额外的管理工作。其次，单独使用场外 EF 与添加现场 IF 相比，在社区环境中能在多大程度上改善患者的治疗效果尚不清楚。最后，在 12 个月的协助后继续表现出无反应的地点中，继续实施策略（即延迟效应）的价值尚未得到评估，特别是在来自更多农村地区的小型实践中。