Effectiveness RCT of Customized Adherence Enhancement

项目概要/摘要 一个基石的治疗，统一建议个人与双相情感障碍（BD）是情绪 稳定药物然而，大约每两个患有BD的个体中就有一个不依从药物治疗， 往往导致严重的负面后果。不幸的是，没有广泛使用的循证医学 针对BD中依从性差的方法。 定制的坚持增强（CAE），由本研究小组开发，是一个简短的，实用的BD特定 一种识别个体依从性障碍的方法，然后使用 灵活管理的模块格式。一项为期6个月的CAE前瞻性随机对照疗效试验（RCT） vs.一项严格控制的BD特定教育（EDU）发现，药物依从性和功能状态 对于粘附性差的患者，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， 平均来说，患有BD的人超过20年。虽然有希望，但最初的疗效RCT是 受限于它是在学术医疗中心进行的事实，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。 针对PA-18-722“提高患者对治疗和预防方案的依从性，以促进 健康”，这一类型1混合有效性实施项目将适应CAE用于社区/公共- 部门护理环境，在这些环境中测试高风险，粘附性差的个人的有效性，并收集 关于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- 起来该项目将审查由以前的工作提出的假定的机械参与目标，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 在4个具体目标中实施：1）在社区心理咨询机构的利益相关者的指导下， 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中心随机对照试验（RCT）比较辅助CAE与常规强化治疗（eTAU），3）测试 CAE与eTAU对BD依从性差个体功能状态的影响，以及4）识别障碍和促进因素 CAE的实施，以通知随后的规模扩大和传播使用定性方法和指导 通过实施概念模型。额外的探索性分析将评估患者- 水平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 评估现场（门诊访视、未就诊率）和非现场（急诊科访视、住院） 用于帮助确定相对价值特点并为今后的可持续性工作提供信息的卫生资源。一个过度的 本项目的目标是提供一种由用户驱动的依从性增强方法， 在公共部门护理环境中实施，可以改善最弱势群体的结果， 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.