Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention

通过电子方式进行的患者自我管理干预促进苯二氮卓类药物戒断

• 批准号: 10754855
• 负责人: Michael Anthony Cucciare
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10754855
• 关键词: Academic Detailing; Accidents; Anxiety; Benzodiazepines; Brain Injuries; Caring; Cellular Phone; Clinical; Clinical Trials; Cognitive; Computers; Conduct Clinical Trials; Databases; Dependence; Development; Dose; Education; Effectiveness; Electronics; Event; Focus Groups; Future; Goals; Health; Healthcare promotion; Impaired cognition; Intervention; Methodology; Methods; Opioid; Overdose; Paper; Patients; Pharmaceutical Preparations; Prevalence; Process; Psychotropic Drugs; Quality of life; Research; Risk; Running; Sampling; Self Assessment; Self Direction; Self Management; Services; Sleep; System; Tablets; Testing; Time; Treatment Protocols; Veterans; Work; addiction; anxiety symptoms; budget impact; connected care; cost; cost estimate; design; effectiveness clinical trial; experience; falls; field study; follow-up; functional outcomes; improved; innovation; interest; intervention cost; medication safety; military veteran; pharmacy benefit; preference; primary care patient; primary care provider; primary outcome; programs; randomized trial; randomized, clinical trials; scale up; sleep quality; smartphone application; tool

Background: Long-term use of benzodiazepine medication has been increasing sharply inside and outside of VA, raising the risk of cognitive decline, falls, and overdose among patients. A self-directed benzodiazepine tapering intervention known as EMPOWER was shown effective in a non-VA clinical trial, and within VA there is significant interest in tailoring it to and providing it for Veterans. Significance: Although often useful as short-term medications, when taken for extended periods benzodiazepines carry risk of cognitive decline and other brain damage, falls and other accidents, benzodiazepine dependence and opioid-benzodiazepine overdose (VA Pharmacy Benefits Management Academic Detailing Service, 2017). This is major concern within VA, which prescribes benzodiazepines to over 350,000 Veterans a year, 2/3 of whom take them long-term (i.e., 3 months or more) (VA Pharmacy Benefits Management Academic Detailing Service, 2017). Innovation: Because the EMPOWER intervention was paper-and- pencil based, it would be useful to convert it to an electronic version that worked on smart phones, tablets, and/or desktop computers. Accordingly, the proposed project intends to convert EMPOWER to electronic format and to tailor it to the needs and preferences of the Veteran population. Specific Aims: Aim 1: Tailor a promising non-VA benzodiazepine cessation intervention (EMPOWER) to Veterans and simultaneously convert it from paper-and-pencil to electronic format. Aim 2: Conduct a randomized clinical trial of the effectiveness of the tailored, electronic intervention (EMPOWER-ED) on VA primary care patients’ benzodiazepine cessation/reduction and functional outcomes. Aim 3: Conduct a budget impact analysis to estimate the costs of implementing the EMPOWER-ED throughout VA. Methodology: This conversion and tailoring will be an iterative process that the project team will conduct via focus groups comprising Veterans, VA primary care providers, and VA operational partners. When the revised intervention, called EMPOWER-ED (for EMPOWER “Electronically Delivered”), is fully designed and has been successfully beta-tested by Veterans, its effectiveness will be evaluated in a randomized clinical trial with 170 Veterans who have been on benzodiazepines for at least 3 months. The primary hypothesis of the study is that those receiving EMPOWER-ED will be significantly more likely than controls to cease benzodiazepines entirely, and, to reduce their dose by at least 25%, at 6-month follow-up. The secondary hypothesis is that Veterans receiving EMPOWER-ED will also experience fewer anxiety symptoms, better sleep quality, and overall health/quality of life at 6-month follow-up. A supplemental analysis of benzodiazepine use only will be conducted using VA databases at 12 months to evaluate whether changes identified at 6 months persist over time. The VA operational partners of the project team (Pharmacy Benefits Management, Psychotropic Drug Safety Initiative, and Office of Connected Care) are committed to disseminating EMPOWER-ED if it proves successful. Therefore, a third aim of the study is to undertake a budget impact analysis to determine what the costs would be to implement EMPOWER-ED in the VA systemwide. Next Steps/Implementation: Because electronically-delivered interventions are inexpensive to disseminate once they have been developed, this project has an excellent chance to promote health care value by creating an easily scaled-up, method of reducing the prevalence of a widespread risk to Veterans’ health.

背景：长期使用苯二氮卓类药物的人群急剧增加 在 VA 之外，会增加 A 患者认知能力下降、跌倒和用药过量的风险。 被称为 EMPOWER 的自我导向苯二氮卓类药物逐渐减少干预措施在以下方面被证明是有效的： 一项非 VA 临床试验，并且在 VA 内部，人们对定制并提供该试验非常感兴趣 对于退伍军人的意义：虽然在服用时通常可用作短期药物。 长期服用苯二氮卓类药物会带来认知能力下降和其他脑损伤、跌倒的风险 和其他事故、苯二氮卓类药物依赖和阿片类药物苯二氮卓类药物过量（VA 药品福利管理学术详细服务，2017 年）这是主要问题。 VA 每年向超过 350,000 名退伍军人开苯二氮卓类药物，其中 2/3 长期服用（即 3 个月或以上）（VA 药房福利管理学术 详细服务，2017）。创新：因为 EMPOWER 干预是纸上谈兵。 基于铅笔，将其转换为可在智能设备上使用的电子版本将很有用 因此，拟议的项目旨在转换手机、平板电脑和/或台式电脑。 授权电子格式并根据退伍军人的需求和偏好进行定制 具体目标： 目标 1：制定有希望的非 VA 苯二氮卓戒断方案。 对退伍军人进行干预（EMPOWER），同时将其从纸笔转换为 电子格式 目标 2：对定制的有效性进行随机临床试验。 对 VA 初级保健患者苯二氮卓类药物的电子干预 (EMPOWER-ED) 目标 3：进行预算影响分析，以实现停止/减少和功能成果。 估计在整个 VA 方法中实施 EMPOWER-ED 的成本：这。 转换和定制将是一个迭代过程，项目团队将通过重点进行 由退伍军人、退伍军人事务部初级保健提供者和退伍军人事务部运营合作伙伴组成的团体。 修订后的干预措施，称为 EMPOWER-ED（EMPOWER“电子交付”），完全 设计并已由退伍军人成功进行测试，其有效性将得到评估 在一项随机临床试验中，有 170 名退伍军人参加，这些退伍军人至少服用苯二氮卓类药物 该研究的主要假设是接受 EMPOWER-ED 的人将 比对照组更有可能完全停止苯二氮卓类药物，并减少其 在 6 个月的随访中，剂量至少减少 25% 第二个假设是退伍军人。 接受 EMPOWER-ED 的焦虑症状也会减少，睡眠质量会更好，并且 6 个月随访时的整体健康/生活质量对苯二氮卓类药物的补充分析。 仅使用将在 12 个月时使用 VA 数据库进行评估是否发生变化 6 个月时确定的项目团队的 VA 运营合作伙伴会持续存在。 （药房福利管理、精神药物安全倡议和互联办公室 Care）致力于传播 EMPOWER-ED，如果它被证明是成功的，因此，第三个。 该研究的目的是进行预算影响分析，以确定成本是多少 在 VA 系统范围内实施 EMPOWER-ED 后续步骤/实施：因为。 通过电子方式提供的干预措施一旦通过，传播起来成本低廉 开发后，该项目有一个极好的机会通过创造一个 一种易于扩大规模的方法，可降低退伍军人健康面临的广泛风险的发生率。