Randomized trial of a leadership and organizational change strategy to improve the implementation and sustainment of digital measurement-based care in youth mental health services

项目摘要/摘要 精神障碍是高收入青年死亡和残疾的主要原因 占疾病总负担的21%，在美国每10个年轻人中就有1人患有严重的 减损。1200多项有效的干预措施或循证做法(EBP)已被证明 改善患有精神障碍的青年的福祉。然而，尽管取得了这些进展，但不到一半的人 在社区环境中接受治疗的青少年症状有所改善，这种情况在很大程度上归因于 社区提供商采用EBP的比率较低，即使采用了EBP，其保真度也较低 都得到了落实和持续。基于数字测量的护理(MBC)系统，收集治疗 从患者的结果数据，并为临床医生提供实时反馈和基于‘BIG’的建议 Data的精算算法，是一种高影响力的数字健康技术，EBP在29个RCT中展示了生成 不同年龄、诊断和治疗方式的临床结果的改善(即，d=.3-.5)。 尽管如此，数字MBC系统很少在年轻人的社区环境中使用，当他们使用时，保真度 而维持性往往很差。最近的审查表明，其中许多措施的实施和维持 赤字可以追溯到缺乏组织级的社会基础设施或社会背景和领导力， 不支持和激励临床医生采用和使用MBC系统；如果没有这种组织社会 在基础设施方面，许多执行努力都以失败告终。这些观察结果与组织氛围一致 行为改变的理论和理论，我们将它们整合在一起，以产生我们的主要假设： 要在社区环境中有效实施和维持MBC，需要建立一个 通过有效的诊所产生了强大的组织实施氛围和高度的临床医生积极性 领导力。在NIH的支持下，我们已经试行测试了一种高度可移植的实施策略，称为 针对这些机制的领导力和组织实施变革(LOCI)。初步 心理健康诊所的研究表明，LOCAL是可行的、可接受的，并能改善实施 领导力和气候。我们建议在20家儿童心理健康诊所进行一项基因座的随机对照试验， 纳入120名临床医生和总共720名青年门诊患者，以测试基因座对 像往常一样实施(IAU)完善的数字MBC对临床医生忠诚度和青年临床结果的影响 在初步实施和维持两个阶段进行干预。 这个项目汇集了一位早期职业/新的调查员(威廉姆斯)，与经验丰富的NIH合作 资助实施科学家(Aarons，Ehrhart)推进关于领导力的方案研究， 改善数字MBC实施和维持的组织和临床医生机制。这项研究 将(1)在初步实施过程中测试基因座对临床医生对MBC和青年临床结果的忠诚度的影响； 和(2)维持；以及(3)测试将基因座与MBC保真度联系起来的多水平机制。

PROJECT SUMMARY/ ABSTRACT Psychiatric disorders are the leading cause of mortality and disability among youth in high income countries, accounting for 21% of total disease burden, and afflicting 1 in 10 youths in the US with severe impairment. Over 1,200 effective interventions, or evidence-based practices (EBPs), have been shown to improve the well-being of youth with psychiatric disorders. However, despite these advances, less than half of youths treated in community settings experience symptom improvement, a situation largely attributed to the low rates at which community providers adopt EBPs and, even when adopted, the low fidelity with which EBPs are implemented and sustained. Digital measurement-based care (MBC) systems, which collect treatment outcome data from patients and provide clinicians with real-time feedback and recommendations based on ‘big data’ actuarial algorithms, are a high-impact digital health technology EBP shown in 29 RCTs to generate improvements in clinical outcomes (i.e., d=.3-.5) across patient ages, diagnoses, and treatment modalities. Despite this, digital MBC systems are rarely used in community settings for youth, and when they are, fidelity and sustainment are often poor. Recent reviews indicate that many of these implementation and sustainment deficits can be traced to a lack of organization-level ‘social infrastructure’ or social contexts and leadership that do not support and motivate clinicians to adopt and use MBC systems; without this organizational social infrastructure, many implementation efforts fail. These observations are consistent with organizational climate theory and theories of behavior change which we have integrated to generate our primary hypothesis: achieving effective implementation and sustainment of MBC in community settings requires mechanisms of a strong organizational implementation climate and high clinician motivation generated through effective clinic leadership. With NIH support, we have pilot tested a highly transportable implementation strategy called Leadership and Organizational Change for Implementation (LOCI) that targets these mechanisms. Preliminary studies in mental health clinics show that LOCI is feasible, acceptable, and improves implementation leadership and climate. We propose a randomized controlled trial of LOCI in 20 children’s mental health clinics, incorporating 120 clinicians and a total of 720 youth outpatients, to test LOCI’s effects relative to implementation as usual (IAU) on clinician fidelity and youth clinical outcomes of a well-established digital MBC intervention during two phases of initial implementation and sustainment. This project brings together an early career/new investigator (Williams) collaborating with experienced, NIH funded implementation scientists (Aarons, Ehrhart) to advance programmatic research on the leadership, organizational, and clinician mechanisms that improve digital MBC implementation and sustainment. The study will (1) test LOCI’s effects on clinician fidelity to MBC and youth clinical outcomes during initial implementation, and (2) sustainment; and (3) test the multilevel mechanisms that link LOCI to MBC fidelity.