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

项目总结/摘要 精神疾病是高收入青年死亡和残疾的主要原因 在美国，每10个年轻人中就有1个患有严重的 损伤超过1，200种有效的干预措施或循证实践（EBP）已被证明 改善患有精神疾病的青年的福祉。然而，尽管取得了这些进展， 在社区环境中接受治疗的青少年症状有所改善，这种情况主要归因于 社区提供者采用EBP的比率低，即使采用EBP， 得到执行和维持。数字化测量护理（MBC）系统，收集治疗信息 从患者的结果数据，并提供临床医生的实时反馈和建议的基础上'大 数据的精算算法，是一个高影响力的数字健康技术EBP显示在29个随机对照试验，以产生 临床结果的改善（即，d= 0.3 - 0.5）。 尽管如此，数字MBC系统很少用于社区环境中的青年人，即使使用， 和可持续性往往很差。最近的审查表明，许多这些执行和维持 缺陷可以追溯到缺乏组织层面的“社会基础设施”或社会背景和领导， 不支持和激励临床医生采用和使用MBC系统;没有这种组织社会 基础设施，许多实施工作失败。这些观察结果与组织气候相一致 理论和行为改变的理论，我们已经整合，以产生我们的主要假设： 要在社区环境中有效实施和维持《地雷行动公约》， 通过有效的诊所产生强大的组织实施氛围和高度的临床医生动机 领导在NIH的支持下，我们对一种高度可移植的实施策略进行了试点测试， 领导和组织变革的实施（LOCI），目标是这些机制。初步 精神卫生诊所的研究表明，LOCI是可行的，可接受的，并改善了实施 领导力和气候。我们建议在20个儿童心理健康诊所进行LOCI的随机对照试验， 纳入120名临床医生和720名青年门诊患者，以测试LOCI相对于 常规实施（IAU）对临床医生忠诚度和成熟数字MBC的青年临床结局的影响 在初步实施和维持两个阶段进行干预。 这个项目汇集了一个早期的职业生涯/新的研究者（威廉姆斯）与经验丰富的合作，NIH 资助实施科学家（Aarons，Ehrhart）推进领导力的方案研究， 组织和临床医生机制，以改善数字MBC的实施和维持。研究 将（1）测试LOCI对临床医生对MBC的忠诚度和初始实施期间的青年临床结果的影响， （2）维持;（3）测试LOCI与MBC保真度之间的多级机制。

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.