Effectiveness RCT of Customized Adherence Enhancement

项目摘要/摘要 情绪是统一推荐给双相情感障碍(BD)患者的治疗基石 稳定的药物治疗。然而，大约每两名BD患者中就有一人不遵守药物治疗， 往往会导致严重的负面后果。不幸的是，没有广泛使用的基于证据的 针对BD遵从性差的方法。 由该研究团队开发的定制遵从性增强(CAE)是一种简短、实用的BD专用软件 一种方法，确定个人遵守障碍，然后使用 灵活管理的模块化格式。CAE的前瞻性、为期6个月的随机对照疗效试验 与严格对照相比，BD专项教育(EDU)发现服药依从性和功能状态 对于依从性差的患者，CAE与EDU相比有所改善。值得注意的是，CAE的好处发生在个人身上 他们平均与BD一起生活了20多年。虽然前景看好，但最初的疗效RCT是 受限于它是在学术医学中心进行的，没有利用现有的网络/文本 消息传递技术，没有解决在标准临床环境中扩大规模的潜在挑战。 响应PA-18-722《提高患者对治疗和预防方案的依从性》促进 健康“，这一类型1混合有效性实施项目将使CAE用于社区/公共- 部门护理环境，在这些环境中的高危、依从性差的个人中测试有效性，并收集 关于实施干预措施的障碍和促进者的证据，以便向后续比额表提供信息-- 向上。该项目将审查先前工作提出的假定的机械性参与目标，并包括 如果调查结果是积极的，将为今后的传播提供信息的执行要素。该项目将是 在4个具体目标中实施：1)在社区心理上完善利益相关者指导的CAE干预 医疗诊所(CMHC)和安全网县医疗系统，2)测试技术的有效性- 易化CAE与常规强化治疗(Etau)使用前瞻性的双部位随机对照试验，3)测试 CAE与Etau在依从性差的BD患者中的功能状态，以及4)确定障碍和促进者 为CAE实施提供信息，以便使用定性方法和指导进行后续的扩展和传播 通过实施概念模型。其他探索性分析将评估患者- 水平依从性障碍和促进剂对依从性的治疗效果起中介作用。最后，该项目将 评估现场(门诊就诊、缺勤率)和非现场(急诊科就诊、住院) 卫生资源使用，以帮助确定相对价值，并为未来的可持续发展努力提供信息。一座拱形建筑 该项目的目标将是提供一种课程驱动的遵守增强方法，该方法可以 在公共部门护理环境中实施，可以改善最脆弱群体的结果 患有BD的人。

PROJECT SUMMARY/ABSTRACT A cornerstone of treatment uniformly recommended for individuals with bipolar disorder (BD) is mood stabilizing medication. However, approximately one in two individuals with BD are non -adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence in BD. Customized Adherence Enhancement (CAE), developed by this study team, is a brief, practical BD -specific approach that identifies individual adherence barriers and then targets these areas for intervention using a flexibly-administered modular format. A prospective, 6-month, randomized controlled efficacy trial (RCT) of CAE vs. a rigorous control, BD-specific education (EDU) found that medication adherence and functional status were improved in CAE vs. EDU for poorly-adherent patients. Remarkably, the benefits of CAE occurred in individuals who had been living with BD, on average, for over 2 decades. While promising, the original efficacy RCT was limited by the fact that it was performed in an academic medical center, did not make use of existing web/text messaging technology, and did not address potential challenges to scale -up in standard clinical settings. In response to PA-18-722 “Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health”, this Type 1 hybrid effectiveness-implementation project will adapt CAE for use in community/public- sector care settings, test effectiveness in high-risk, poorly adherent individuals in these settings, and gather evidence on barriers and facilitators to implementation of the intervention in order to inform subsequent scale- up. The project will examine putative mechanistic engagement targets suggested by previous work and include implementation elements that will inform future dissemination should findings be positive. The project will be implemented in 4 specific aims: 1) Refine the CAE intervention guided by stakeholders at a community mental health clinic (CMHC) and a safety-net county healthcare system, 2) Test the effectiveness of technology- facilitated CAE vs. enhanced treatment as usual (eTAU) using a prospective, 2-site RCT, 3) Test the effects of CAE vs. eTAU on functional status in poorly adherent individuals with BD, and 4) Identify barriers and facilitators to CAE implementation in order to inform subsequent scale-up and spread using qualitative methods and guided by implementation conceptual models. Additional exploratory analysis will assess whether changes in patient- level adherence barriers and facilitators mediate the treatment effects on adherence. Finally, the project will evaluate on-site (outpatient visits, no-show rates) and off-site (emergency department visits, hospitalizations) health resource use to help characterize relative value and inform future sustainability efforts. An over-arching goal of this project will be to provide a curriculum-driven adherence enhancement approach that can be implemented in public-sector care settings and which can improve outcomes for the most vulnerable groups of people with BD.