Effectiveness RCT of Customized Adherence Enhancement

项目概要/摘要 一致推荐双相情感障碍 (BD) 患者治疗的基石是情绪 稳定药物。然而，大约二分之一的双相情感障碍患者不坚持服药， 往往会导致严重的负面后果。不幸的是，目前还没有广泛使用的基于证据的方法 针对 BD 依从性差的方法。 该研究团队开发的定制依从性增强 (CAE) 是一种简短、实用的 BD 特定方法 方法识别个人依从性障碍，然后针对这些领域进行干预 灵活管理的模块化格式。 CAE 的一项为期 6 个月的前瞻性随机对照疗效试验 (RCT) 与严格的控制相比，BD 特定教育 (EDU) 发现药物依从性和功能状态 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 平均患有双相情感障碍超过 20 年。虽然前景广阔，但最初的随机对照试验疗效是 受限于它是在学术医疗中心进行的，没有利用现有的网络/文本 消息传递技术，并且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，以促进 Health”，这个 1 类混合有效性实施项目将调整 CAE 以用于社区/公共- 部门护理机构，测试这些机构中高风险、依从性差的个人的有效性，并收集 有关实施干预措施的障碍和促进因素的证据，以便为后续规模提供信息 起来。该项目将检查先前工作建议的假定机械参与目标，包括 如果调查结果是积极的，则将为未来传播提供信息的实施要素。该项目将是 实施了 4 个具体目标： 1) 在社区心理利益相关者的指导下完善 CAE 干预措施 健康诊所 (CMHC) 和安全网县医疗保健系统，2) 测试技术的有效性- 使用前瞻性 2 点随机对照试验，比较促进 CAE 与常规强化治疗 (eTAU)，3) 测试以下措施的效果 CAE 与 eTAU 对依从性差的双相情感障碍患者功能状态的比较，以及 4) 识别障碍和促进因素 CAE 实施，以便使用定性方法和指导的方式为后续的扩大和推广提供信息 通过实施概念模型。额外的探索性分析将评估患者的变化是否 依从性障碍和促进因素介导治疗对依从性的影响。最后，该项目将 现场评估（门诊就诊、缺席率）和场外评估（急诊科就诊、住院治疗） 卫生资源的使用有助于描述相对价值并为未来的可持续发展工作提供信息。一个包罗万象的 该项目的目标是提供一种课程驱动的依从性增强方法，该方法可以 在公共部门护理机构中实施，可以改善最弱势群体的结果 患有双相障碍的人。

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.