Improving Mental Health Outcomes: Buidling an Adaptive Implementation Strategy

描述（由申请人提供）：尽管有基于社会心理证据的实践（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。复制有效方案（REP）是一项实施干预措施，用于在社区实践中促进社会心理治疗的使用，但结果仍不到一半的地点实际维持了这些治疗的使用。基于我们之前的R01 （MH79994）社区合作伙伴的投入，研究团队随后增强了REP，包括促进，这是一种新的实施干预措施，它解决了在REP强调保密性之外采用EBP的现场级组织障碍。发展了两种促进角色：外部和内部促进者。外部助理员（EFs）驻留在诊所之外，由研究提供支持，并向提供者提供在日常实践中适应和使用ebp的技术专业知识。内部促进者（if）由站点雇用，与站点领导有直接的报告关系，并有保护时间来开展活动，以帮助站点计划拥护者实施ebp。IFs还解决了在基线或EFs中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，包括REP和增强EF和IF的作用，以改善患者的预后，并在社区环境中接受EBP治疗情绪障碍（Life goal - lg）。本聚类随机试验的主要目的是确定在最初对REP无反应的部位（即LG吸收有限）中，在接受外部和内部促进剂（REP+EF/IF）的部位与单独接受外部促进剂（REP+EF）的部位进行适应性实施干预对改善患者水平结果的影响，包括精神健康生活质量和症状减轻，以及12个月后情绪障碍患者中LG使用的增加。次要目的是确定在12个月后继续表现为无反应的地点中，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，并在24个月期间对REP+EF/IF与REP+EF进行成本-效果分析。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（共1,600名患者）的代表性队列将被纳入本研究。我们将使用顺序多重分配随机试验（SMART）设计来构建最佳自适应实施干预。这项开创性的研究设计将解决三个关键的实施问题：首先，IFs对站点来说成本很高，因为它们需要额外的管理工作。其次，在社区环境中，单独的非现场IF与增加的现场IF在多大程度上可以改善患者的预后尚不清楚。最后，在12个月的促进后仍然没有反应的站点中，继续实施战略的价值（即延迟效应）尚未得到评估，特别是在农村地区的小型实践中。

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.