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

背景：苯二氮卓类药物的长期使用在国内急剧增加 在VA之外，会增加患者认知能力下降、摔倒和服药过量的风险。一个 被称为EMPOWER的自我定向苯二氮卓类缩减干预在#年被证明有效 一项非退伍军人事务部的临床试验，退伍军人事务部对为其量身定做并提供该试验非常感兴趣。 对退伍军人来说。意义：虽然通常作为短期药物有用，但当服用时 长时间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 以及其他事故，苯二氮类药物依赖和阿片类药物-苯二氮类药物过量(VA 药房福利管理学术详细服务，2017)。这是最令人担忧的 在退伍军人管理局内，每年为超过35万名退伍军人开苯二氮卓类药物，其中三分之二 长期(即，3个月或更长时间)(退伍军人管理局福利管理学院 详述服务，2017)。创新：因为赋权干预是纸上谈兵 以铅笔为基础，将其转换为适用于SMART的电子版本将是有用的 手机、平板电脑和/或台式计算机。因此，拟议的项目打算将 支持电子格式，并根据退伍军人的需求和偏好进行定制 人口。具体目标：目标1：量身定制一种有希望的非VA苯二氮卓类戒断药物 对退伍军人进行干预(授权)，同时将其从纸上谈兵转变为 电子格式。目的2：进行一项随机临床试验，观察特制、 电子干预(Empower-ED)对VA初级保健患者苯二氮类药物的影响 停药/减量和功能结果。目标3：进行预算影响分析，以 估计在退伍军人事务部实施授权教育的成本。方法论：这 转换和定制将是一个迭代过程，项目团队将通过Focus进行 由退伍军人、退伍军人初级保健提供者和退伍军人管理局运营合作伙伴组成的小组。当 修订后的干预措施被称为Empower-ED(Empower“电子交付”的意思)，是完全 设计并已成功通过退伍军人的Beta测试，其有效性将得到评估 在一项随机临床试验中，170名退伍军人至少服用苯二氮卓类药物 三个月。这项研究的主要假设是，那些接受赋权-ED的人将是 与对照组相比，完全停用苯二氮类药物的可能性要大得多，并减少它们的 剂量至少减少25%，在6个月的随访中。第二个假设是退伍军人 接受Empower-Ed还将经历更少的焦虑症状，更好的睡眠质量，以及 6个月随访时的总体健康/生活质量。苯二氮卓类药物的补充分析 仅在12个月后使用VA数据库进行使用，以评估是否发生变化 随着时间的推移，6个月的时间会持续存在。项目组的退伍军人事务部业务合作伙伴 (药房福利管理、精神药物安全倡议和互联办公室 CARE)致力于传播赋权教育，如果证明成功的话。因此，三分之一的人 这项研究的目的是进行预算影响分析，以确定成本是多少 在退伍军人管理局系统内实施Empower-ED。下一步/实施：因为 电子传递的干预措施一旦实施，传播成本就会很低 发展起来，这个项目有一个极好的机会，通过创造一个 这是一种易于推广的方法，可以降低退伍军人健康面临的普遍风险。

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.