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（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。复制有效的方案（REP），实施干预措施，以促进在社区为基础的做法中使用心理治疗，仍然导致不到一半的网站实际上维持使用这些治疗。根据我们之前R 01（MH 79994）的社区合作伙伴的输入，研究团队随后增强了REP，以包括促进，这是一种新颖的实施干预措施，它解决了REP强调保真度之外的EBP采用的现场级组织障碍。开发了两个促进角色：外部和内部促进者。外部促进者（EF）居住在诊所外，由研究提供支持，并为供应商提供技术专业知识，以适应和使用EBP在常规实践中。内部辅导员（IF）由研究中心雇用，与研究中心领导层有直接报告关系，并有保护时间开展活动，以帮助研究中心项目负责人实施EBP。综合框架还解决了在基线或环境框架中可能无法观察到的具体地点的组织障碍。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，涉及REP和增强EF和IF的作用，以改善患者的预后和在社区环境中对情绪障碍（生活目标-LG）的EBP的摄取。这项聚类随机试验的主要目的是确定，在最初对REP没有反应的部位中（即，有限的LG摄取），在接受外部和内部促进剂（REP+EF/IF）与单独使用外部促进剂（REP+EF）的站点中进行适应性实施干预对改善患者水平结局的影响，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中LG使用增加。次要目的是在12个月后继续显示无应答的研究中心中，确定24个月时继续促进对患者水平结局的影响，描述EF和IF的实施情况，并在24个月期间对REP+EF/IF与REP+EF进行成本效益分析。本研究将纳入来自美国不同地区（密歇根州、科罗拉多和阿肯色州）的100家社区门诊诊所（共1，600例患者）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：首先，IF对研究中心来说成本很高，因为它们需要额外的管理工作。其次，在社区环境中，单独的场外EF与增加现场IF在多大程度上可以改善患者结局尚不清楚。最后，在12个月的促进后继续显示无响应的研究中心中，继续实施策略的价值（即，延迟效应）尚未得到评估，特别是在来自更多农村环境的较小做法中。

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.