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 然而，大约二分之一的 BD 患者不坚持用药， 不幸的是，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 灵活管理的模块化形式的 CAE 前瞻性、为期 6 个月的随机对照疗效试验 (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 的益处发生在个体身上。 平均患有双相情感障碍超过 20 年的患者虽然很有希望，但最初的随机对照试验疗效是有限的。 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，以便随后为规模提供信息 该项目将检查先前工作建议的假定机械接合目标，包括。 如果该项目的研究结果是积极的，那么这些实施要素将为未来的传播提供信息。 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 RCT 比较促进 CAE 与常规强化治疗 (eTAU)，3) 测试以下效果 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性方法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是否发生变化。 最后，该项目将调节依从性水平和促进者对依从性障碍的治疗效果。 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。 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。