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: 10492481
• 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/10492481
• 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.

研究背景：长期使用苯二氮卓类药物的病例在急剧增加 而在VA之外，增加了患者认知能力下降、福尔斯和用药过量的风险。一 自我导向的苯二氮卓类药物减量干预（称为EMPOWER）在以下方面有效： 一项非VA临床试验，在VA内部，有很大的兴趣定制并提供它， 对于退伍军人。意义：虽然经常作为短期药物使用，但当服用时， 长期服用苯二氮卓类药物会导致认知能力下降和其他脑损伤，福尔斯 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 药房福利管理学术详细服务，2017年）。这是一个主要的问题 在弗吉尼亚州，每年向超过35万名退伍军人开苯二氮卓类药物，其中2/3的人 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年）。创新：因为EMPOWER干预是纸和- 基于铅笔的，这将是有用的，将其转换为电子版本，工作在智能 电话、平板电脑和/或台式计算机。因此，拟议项目拟将 授权电子格式，并根据退伍军人的需求和偏好进行调整 人口具体目标：目标1：定制有希望的非VA苯二氮卓类药物戒烟方案 干预（授权），以退伍军人，同时将其从纸和笔， 电子格式。目的2：进行一项随机临床试验， 电子干预（EMPOWER-ED）对VA初级护理患者苯二氮卓类药物的影响 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实施EMPOWER-ED的成本。方法：这 转换和裁剪将是一个迭代的过程，项目团队将通过焦点进行 包括退伍军人，VA初级保健提供者和VA业务合作伙伴的团体。当 修订后的干预措施，称为EMPOWER-ED（EMPOWER“电子交付”）， 设计并已成功地由退伍军人测试，其有效性将进行评估 在一项随机临床试验中，170名退伍军人服用苯二氮卓类药物至少 3个月这项研究的主要假设是，那些接受增强权能教育的人将 比对照组更有可能完全停用苯二氮卓类药物， 在6个月随访时，剂量至少降低25%。第二个假设是， 接受EMPOWER-ED的患者也会经历更少的焦虑症状，更好的睡眠质量， 6个月随访时的总体健康状况/生活质量。苯二氮卓类药物的补充分析 仅使用VA数据库在12个月时进行，以评价是否发生变化 在6个月时发现的持续时间。项目团队的VA业务合作伙伴 （药房福利管理，精神药物安全倡议和办公室连接 护理）致力于传播增强能力-教育，如果它证明是成功的。因此，第三 这项研究的目的是进行预算影响分析，以确定费用是多少 在退伍军人事务部全系统实施增强权能和发展方案。下一步/实施：因为 电子交付的干预措施一旦发布， 开发，这个项目有一个很好的机会，以促进医疗保健的价值，创造一个 这是一种易于扩大规模的方法，可以降低退伍军人健康普遍面临的风险。