Antidepressant Adherence via Telephonic Interactive Voice Recognition (IVR)

通过电话交互式语音识别 (IVR) 实现抗抑郁药物依从性

• 批准号: 8231555
• 负责人: GREGORY N CLARKE
• 金额: $ 57.51万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8231555
• 关键词: 21 year old; AIDS/HIV problem; Adherence; Adoption; Adult; Affect; Antidepressant adherence; Antidepressive Agents; Anxiety; Anxiety Disorders; Area; Characteristics; Chronic Disease; Client; Complex; Computerized Medical Record; Data; Development; Diagnosis; Disease; Disease Management; Distal; Education; Effectiveness; Enrollment; Focus Groups; Future; Grant; Group Interviews; Health Care Costs; Health Maintenance Organizations; Health Services; Health Status; Healthcare; Incentives; Information Technology; Internet; Intervention; Interview; Life; Mails; Maintenance; Measures; Mental Depression; Mental disorders; Methods; NIH Program Announcements; National Institute of Mental Health; Outcome; Participant; Patient Education; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Population; Provider; Quality-Adjusted Life Years; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research Personnel; Research Project Grants; Rural; Services; Site; Solutions; Symptoms; System; Technology; Telephone; Testing; Time; Uncertainty; Unipolar Depression; United States Agency for Healthcare Research and Quality; Visit; abstracting; arm; base; chronic care model; clinically relevant; common treatment; compliance behavior; cost; cost effectiveness; dissemination trial; economic evaluation; experience; follow-up; health care service utilization; health information technology; implementation trial; improved; informant; innovation; medication compliance; member; practice-based research network; primary outcome; programs; public health relevance; response; safety net; satisfaction; secondary outcome; service intervention; speech recognition; success; treatment adherence; treatment as usual; trial comparing; voice recognition; willingness to pay

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.

描述（由申请人提供）：抗抑郁药 (AD) 是最常用的一类精神药物，也是抑郁症和焦虑症最常见的治疗方法，但患者依从性较差，并且被广泛认为会导致疗效降低。幸运的是，AD 依从性可以通过符合慢性护理模式 (CCM) 的干预措施来提高。然而，传统上提供的依从性促进计划复杂、人员密集且成本高昂，阻碍了这些计划在现实环境中更广泛的采用、实施和维护。我们的目标是试验一项低成本、IT 支持的 AD 依从性计划，特别是直接面向患者的自动电话交互式语音识别 (IVR) 干预措施，以提高患者 AD 的持续性。这种干预措施与 CCM 一致，但更适合在大量人群中广泛传播。在最初的启动阶段，我们将根据形成性焦点小组和关键信息提供者（患者、提供者）的访谈，调整和试点现有的 IVR 依从性通话和脚本。此后，我们将开展一项务实的随机临床试验，招募 3,100 名年龄在 21 至 75 岁之间的 HMO 成员，最近开始针对相关单相抑郁和/或焦虑诊断进行 AD 药物治疗。参与者将按 1:1 的比例随机分配至照常治疗 (TAU) 对照条件组或 TAU 加 IVR 自动电话程序组。招募将持续 18 个月，并定期对参与者进行为期 40 周的随访。 IVR 程序将根据预计的 AD 补充日期提供提醒和/或迟到呼叫。干预措施还可以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 电子病历 (EMR) 中提取的处方补充数据得出的 AD 治疗持续性估计水平 (ELPT)。我们假设 IVR 研究组的参与者的 AD 持续率将显着高于 TAU 对照条件下的参与者。次要药物依从性结果包括药物获取的连续测量（CMA）和药物差距的连续测量（CMG）。其他次要结果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成本和使用情况。我们还将进行成本效益分析 (CEA)，以评估 IVR 技术与 TAU 相比的性价比（获得的每无抑郁日的成本，以及获得的每质量调整生命年的成本）。成本将包括 IVR 开发和实施以及 EMR 衍生的医疗保健利用数据（就诊、药物等），并补充计划外服务的参与者报告。最后，将与主要利益相关者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。 公共卫生相关性：服用抗抑郁药物的人往往过早停止服用而无法获得充分的益处。现有的计划可以帮助这些患者延长服药时间，但大多数计划过于复杂且成本高昂，无法广泛使用。这项研究将测试一个自动电话呼叫程序，以帮助患者在正确的时间获得补充药物并延长抗抑郁药物的使用时间。该计划成本低廉，并且比其他方法更容易向广大人群提供。