Effectiveness RCT of Customized Adherence Enhancement

定制依从性增强的有效性随机对照试验

• 批准号: 10598526
• 负责人: Jennifer Beth Levin
• 金额: $ 69.83万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10598526
• 关键词: Academic Medical Centers; Adherence; Administrator; Anticonvulsants; Antipsychotic Agents; Area; Bipolar Disorder; Caring; Characteristics; Clinic; Clinical; Communities; Corrosives; County; Education; Educational Curriculum; Effectiveness; Elements; Emergency department visit; Enrollment; Environment; Evaluation; Event; Family; Future; Generations; Goals; Guidelines; Health Promotion; Health Resources; Healthcare Systems; Hospitalization; Individual; Internet; Intervention; Intervention Studies; Life; Lithium; Mediating; Mental Health; Mental Health Services; Modeling; Moods; Outcome; Outpatients; Patients; Persons; Pharmaceutical Preparations; Prevention; Promoting Action on Research Implementation in Health Services framework; Provider; Public Health; Public Sector; Qualitative Methods; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Recovery; Regimen; Relapse; Reporting; Review Literature; Site; System; Technology; Testing; Text Messaging; United States Department of Veterans Affairs; Visit; Vulnerable Populations; Work; compliance behavior; cost; design; effectiveness testing; effectiveness/implementation hybrid; efficacy trial; evidence base; family support; flexibility; functional improvement; functional status; health care settings; high risk; high risk population; implementation facilitators; implementation intervention; improved; improved outcome; individual patient; innovation; medication compliance; programs; prospective; psychiatric comorbidity; randomized controlled design; response; safety net; scale up; suicide rate; treatment as usual; treatment effect

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.

项目摘要/摘要 对双相情感障碍（BD）统一建议的治疗基石是情绪 稳定药物。但是，大约有二分之一的BD患者对药物不遵守， 通常导致严重和负面后果。不幸的是，没有广泛使用的循证 靶向BD中依从性差的方法。 由该研究团队开发的定制依从性增强（CAE）是一个简短的实用BD特定的 识别个人依从性障碍，然后将这些区域针对干预的方法 灵活地管理模块化格式。 CAE的前瞻性，6个月的随机对照效率试验（RCT） 与严格控制的BD特定教育（EDU）发现，药物依从性和功能状态是 针对不良患者的CAE与EDU的改善。值得注意的是，CAE的好处发生在个人中 他平均居住了超过20年的BD。虽然很有希望，但原始效率RCT是 受到在学术医学中心进行的事实的限制，没有使用现有的网络/文本 消息传递技术，并且没有解决标准临床环境中规模扩展的潜在挑战。 响应PA-18-722“改善患者对治疗和预防方案的依从性以促进 健康”，这种1型混合有效性 - 实现项目将适应社区/公共的CAE 部门护理环境，在这些环境中的高风险，依从性较差的人的测试效果，并收集 有关实施干预措施的障碍和促进者的证据，以告知随后的规模 向上。该项目将检查以前工作建议的假定的机械参与目标，并包括 将为未来传播的实施要素应该是积极的。该项目将是 在4个具体目标中实施：1）在社区心理上的利益相关者指导的CAE干预措施 健康诊所（CMHC）和安全网络计数医疗系统，2）测试技术的有效性 - 使用前瞻性的2个站点RCT，促进CAE与往常一样（ETAU）的促进治疗（ETAU），3）测试 CAE与ETAU关于BD依附的人的功能状况 为了使用定性方法为随后的扩展和传播提供信息，并指导 通过实施概念模型。其他探索性分析将评估患者的变化 - 水平的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（门诊就诊，未出现的率）和异地（急诊就诊，住院） 健康资源用来帮助表征相对价值并为未来的可持续性工作提供信息。一个超大的 该项目的目标将是提供一种课程驱动的依从性增强方法 在公共部门的护理环境中实施，这可以改善最脆弱的群体的成果 BD的人。