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：苯二氮卓类药物的长期使用一直在急剧增加 在VA之外，患者中增加了认知能力下降，跌倒和过量的风险。一个 自我指导的苯二氮卓类锥度干预措施被称为Empower 一项非VA临床试验，在VA内，对将其定制并提供给它很有兴趣 意义：尽管通常用作短期药物，但服用 长时间苯二氮卓类药物具有认知能力下降和其他脑损伤的风险，跌倒 和其他事故，苯二氮卓类依赖性和阿片类苯并二氮卓类药物过量（VA 药房福利管理学术细节服务，2017年）。这是主要问题 在VA内，该苯二氮卓，每年为350,000多名退伍军人，其中2/3 长期带它们（即3个月或更长时间）（VA药房福利管理学术 详细服务，2017年）。创新：因为授权干预是纸张和 - 基于铅笔，将其转换为可用于SMART的电子版本是有用的 电话，平板电脑和/或台式计算机。根据每个计划的项目，都打算转换 授权电子格式并根据退伍军人的需求和偏好进行调整 人口。具体目的：目标1：量身定制有希望的非VA苯二氮卓及 干预（授权）向退伍军人，然后将其从纸笔转换为 电子格式。 AIM 2：对量身定制的有效性进行随机临床试验， VA初级保健患者苯二氮卓类的电子干预（Empower-ED） 停止/减少和功能结果。目标3：进行预算影响分析 估计在整个VA中实施授权的成本。方法论：这 转换和裁缝将是一个迭代过程，项目团队将通过重点进行 组成退伍军人，VA初级保健提供者和VA运营合作伙伴的小组。什么时候 修订的干预措施，称为Empower-ED（对于“电子交付”），已完全 设计并已通过退伍军人成功进行了β测试，其有效性将得到评估 在一项随机临床试验中，有170名退伍军人至少在苯二氮卓类药物上 3个月。该研究的主要假设是那些接收授权的人将是 比对照完全停止苯二氮卓类药物的可能性要高得多，并减少其 在6个月的随访中，剂量至少为25％。次要假设是退伍军人 接收Empower-ED还将遇到更少的焦虑症状，更好的睡眠质量和 在6个月的随访中的整体健康/生活质量。苯二氮卓类的补充分析 仅在12个月时使用VA数据库进行使用，以评估是否发生变化 随着时间的流逝，持续存在6个月。项目团队的VA运营合作伙伴 （药房福利管理，精神药物安全计划和连接办公室 如果事实证明成功，则致力于传播授权。因此，三分之一 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系统范围内实现Empower-ed。下一步/实现：因为 电子交付的干预措施是一旦经过的便宜 该项目开发了，有一个很好的机会来通过创建一个 很容易扩大，减少退伍军人健康风险的普遍风险的方法。