Antidepressant Adherence via Telephonic Interactive Voice Recognition (IVR)

描述（由申请人提供）：抗抑郁药（ADs）是最常用的精神药物，也是抑郁症和焦虑症最常用的治疗方法，但患者的依从性很差，被广泛认为是导致疗效降低的原因。幸运的是，AD依从性可以通过与慢性护理模式（CCM）相一致的干预措施得到改善。然而，传统的依从性促进计划是复杂的、人员密集的、昂贵的，这是在现实环境中更广泛地采用、实施和维护这些计划的障碍。我们的目标是开展一项低成本、it支持的AD依从性项目的试验，特别是一种直接面向患者的自动电话交互式语音识别（IVR）干预，以提高患者AD的持久性。这种干预与CCM一致，但更适合在大量人口中广泛传播。在最初的启动阶段，我们将调整和试点现有的IVR依从性呼叫和脚本，通过形成焦点小组和对关键线人（患者，提供者）的采访获得信息。在此之后，我们将进行一项实用的随机临床试验，招募3100名年龄在21至75岁之间的HMO成员，最近开始进行AD药物治疗相关单极抑郁和/或焦虑诊断的事件疗程。参与者将以1:1的比例随机分配到常规治疗（TAU）控制条件或TAU加IVR自动电话程序。招募将持续18个月，定期随访40周。IVR程序将提供提醒和/或延迟呼叫，定时到预计的AD补充日期。干预还可选择提供简短的心理教育，或转移到现场药剂师或HMO邮件补充药房。主要结果将是基于从HMO的电子医疗记录（EMR）中提取的处方补充数据，ADs的估计持续治疗水平（ELPT）。我们假设IVR研究组的参与者比TAU控制组的参与者有更高的AD持续率。二级药物依从性结局包括药物获得的连续测量（CMA）和药物缺口的连续测量（CMG）。其他次要结局包括自我报告的抑郁和焦虑症状、一般健康状况、患者和提供者满意度以及医疗保健费用和使用情况。我们还将进行成本效益分析（CEA），以评估IVR技术与TAU相比的物有所值（获得的每个无抑郁日的成本和获得的每个质量调整生命年的成本）。成本将包括IVR的开发和实施，以及emr衍生的医疗保健利用数据（访问、药物等），以及参与者对计划外服务的报告。最后，将与主要利益攸关方进行评估性定性访谈，以确定干预措施实施的障碍/促进因素——未来传播的关键。

DESCRIPTION (provided by applicant): Antidepressants (ADs) are the most frequently prescribed class of psychotropic medications and the most common treatment for depression and anxiety disorders-yet patient adherence is poor and is widely viewed as contributing to reduced effectiveness. Fortunately, AD adherence can be improved via interventions consistent with the Chronic Care Model (CCM). However, traditionally- delivered adherence promotion programs are complex, staff-intensive, and costly-barriers to wider adoption, implementation, and maintenance of these programs in real-world settings. Our aim is to carry out a trial of a low-cost, IT-enabled AD adherence program, specifically a direct-to-patient, automated telephone interactive voice recognition (IVR) intervention to boost patient AD persistence. This intervention is consistent with the CCM but is much more amenable to widespread dissemination over a large population. In an initial startup period we will adapt and pilot existing IVR adherence calls and scripts, informed by formative focus groups and interviews with key informants (patients, providers). Following this, we will conduct a pragmatic, randomized clinical trial enrolling 3,100 HMO members ages 21 to 75, recently started on an incident course of AD medications for associated unipolar depression and/or anxiety diagnoses. Participants will be randomized 1:1 to either a treatment as usual (TAU) control condition or to TAU plus the IVR automated telephone program. Recruitment will continue for 18 months, with periodic participant-level follow-up for 40 weeks. The IVR program will deliver reminder and/or tardy calls timed to projected AD refill dates. The intervention also optionally offers brief psycho-education, or transfer to a live pharmacist or the HMO mail refill pharmacy. The primary outcome will be the Estimated Level of Persistence with Therapy (ELPT) for ADs, based on prescription refill data abstracted from the HMO's electronic medical record (EMR). We hypothesize that participants in the IVR study arm will have a significantly higher rate of AD persistence than those in the TAU control condition. Secondary medication adherence outcomes include continuous measure of medication acquisition (CMA) and continuous measure of medication gaps (CMG). Other secondary outcomes include self-report depression and anxiety symptoms, general health status, patient and provider satisfaction, and healthcare costs and usage. We will also conduct cost-effectiveness analyses (CEA) to assess the value-for-money (cost per depression free day gained, and cost per quality adjusted life year gained) of the IVR technology compared to TAU. Costs will include IVR development and implementation as well as EMR-derived healthcare utilization data (visits, medications, etc.), augmented with participant report of out-of-plan services. Finally, evaluative qualitative interviews will be conducted with key stakeholders to identify barriers/facilitators of intervention implementation-keys for future dissemination. PUBLIC HEALTH RELEVANCE: Persons taking antidepressant medication often stop too early to get full benefit. Programs exist to help these patients stay on medication longer, but most are too complicated and costly to be widely used. This study will test an automated telephone calling program to help patients obtain refills at the right time and stay on antidepressants longer. This program is low cost and can be delivered to widespread populations much more easily than other approaches.