Improving Mental Health Outcomes: Buidling an Adaptive Implementation Strategy

描述(由申请人提供)：尽管有心理社会循证实践(EBPS)，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太理想。复制有效计划(REP)是一种实施干预措施，旨在促进在基于社区的实践中使用心理社会治疗，但结果仍然不到一半的网站实际维持了这些治疗的使用。基于我们之前的R01(MH79994)中社区合作伙伴的意见，研究小组随后加强了REP，将其包括在内，这是一种新颖的实施干预措施，解决了现场层面的组织障碍，使EBP的采用超越了REP对保真度的强调。发展了两种促进作用：外部和内部促进者。外部促进者(EFS)驻留在诊所外，由研究提供支持，并为提供者在日常实践中适应和使用EBPS提供技术专业知识。内部协调人(IF)受雇于现场，与现场领导层有直接的汇报关系，并有保障的时间开展活动以帮助现场计划冠军实施EBP。IFS还解决了现场特定的组织障碍，这些障碍在基线或EFS中可能无法观察到。这项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，包括REP和EF和IF的增强作用，以改善患者结局和在社区环境中采用EBP治疗情绪障碍(生活目标-LG)。这项分组随机试验的主要目的是，在最初对REP没有反应(即LG摄入量有限)的站点中，确定接受外部和内部促进器(REP EF/IF)的站点与单独接受外部促进器(REP EF)的站点的适应性实施干预对改善患者水平结果的效果，包括心理健康生活质量和症状的减少，以及12个月后情绪障碍患者使用LG的增加。次要目标是，在12个月后继续表现为无反应的站点中，确定持续促进对24个月后患者水平结果的影响，描述EF和IF的实施情况，并对24个月期间REP EF/IF与REP EF进行成本效益分析。这项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家社区门诊诊所(总计1600名患者)的代表性队列。我们将使用序贯多分配随机试验(SMART)设计来构建最佳适应性实施干预。这一开创性的研究设计将解决三个关键的实施问题：第一，综合框架对站点来说代价高昂，因为它们需要额外的管理工作。其次，在社区环境中，单独进行场外EF与增加现场IF相比，在多大程度上可以改善患者的预后尚不清楚。最后，在便利化12个月后仍然没有反应的地点中，尚未评估继续执行战略(即延迟效果)的价值，特别是在较农村地区的较小规模做法中。

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.