VA response to guidance regarding risks of psychotropic medication use

 描述(由申请人提供)： 背景：最近食品和药物管理局(FDA)的警告和医学会指南关注与精神药物相关的潜在健康风险，建议对临床实践进行修改。这些类型的循证政策可能会对公众健康和安全产生重要影响。退伍军人管理局药房福利管理服务(VA PBM)是我们在这项研究中的主要业务合作伙伴，负责发起退伍军人管理局对FDA警告的回应。尽管退伍军人PBM使用了几种方法向退伍军人综合服务网络(VISN)、退伍军人管理局和供应商传达警告，但关于影响对这些警告的响应的多种背景和组织因素仍不清楚。更好地了解退伍军人管理局系统和提供者级别的响应能力可能会导致开发和分享最佳实践，并为未来改进警告采用的战略提供信息，从而改善患者护理和人口安全。目的：鉴于精神药物处方实践中存在相当大的VA设施水平差异，本研究的首要目标是检查对有关精神药物的外部警告的多水平反应。我们试图了解VISN、退伍军人管理局和供应商采用警告的差异，以及不同程度的药房整合对警告响应的影响。我们将使用两个最近旨在降低与精神药物相关的风险的警告的例子：1)与大剂量抗抑郁药西酞普兰[Celexa]相关的突发心脏事件；5，6和2)与镇静催眠药物唑吡坦[Ambien]相关的驾驶障碍。7，8在此背景下，我们将解决以下三个具体目标：目标1：评估和描述PBM和VISN水平的反应性以及对有关精神药物的警告的反应性变化。目的2：评估精神药物警告前后的处方模式。目标3：了解对警告反应较高的设施和提供者使用的具体策略，以及对警告反应较低的设施和提供者遇到的障碍。方法：采用定性(使用理论驱动的半结构访谈)和定量(使用调查和行政数据)两种方法，我们将评估可能影响设施和提供者对警告的响应的多种因素。这项研究将是第一次在大型国家卫生系统中对精神药物警告进行混合方法的纵向研究。目标1将基于对每个VISN(N=21)的国家退伍军人管理局领导人和药房负责人的半结构化访谈，详细说明VHA制定政策和指南的过程，如何实现传播，以及整个系统采用的可感知的障碍和促进者。AIM 2将使用分段回归技术，使用警告前和警告后的管理数据来确定VISN和设施在VHA中精神药物处方和患者健康监测的变化。AIM 3将详细说明设施和提供者为响应警告和PBM传播努力而改变做法的过程。将与目标3A的机构负责人(药房、初级保健、精神健康)进行访谈，并将对初级保健提供者(PCP)和目标3B的精神病学家进行调查，所有这些人都将根据目标1和2的调查结果进行有意抽样。本项目开发和改进的方法将适用于关于精神健康治疗和药物监督的广泛政策。对退伍军人健康的预期影响：这项建议的影响来自于它有能力通过将前所未有的数据资源、定性和定量方法、组织理论的新应用以及不同的调查人员专业知识结合在一起，克服以前研究的弱点。这项工作可以改善临床护理和患者的安全，直接造福于退伍军人管理局实践和患者。

 DESCRIPTION (provided by applicant): Background: Recent Food and Drug Administration (FDA) warnings and medical association guidelines focus on potential health risks associated with psychotropic medications, suggesting modifications for clinical practice. These types of evidence-based policies can have an important impact on public health and safety. The VA Pharmacy Benefits Management Services (VA PBM), our primary operational partner in this study is responsible for initiating VA responses to FDA warnings. Despite VA PBM's use of several approaches to convey warnings to Veterans Integrated Service Networks (VISNs), VA facilities, and providers, much remains unknown about the multiple contextual and organizational factors influencing responsiveness to these warnings. A better understanding of VA system and provider level responsiveness could lead to developing and sharing best practices and informing future strategies to improve warning adoption, thereby improving patient care and population safety. Objectives: Given that considerable VA facility-level variation exists in psychotropic prescribing practices, the overarching goal of this study is to examine multilevel responses to external warnings regarding psychotropic medications. We seek to understand variation in the adoption of warnings by VISNs, VA facilities, and providers, and the effect of varying levels of pharmacy integration on response to warnings. We will use two examples of recent warnings designed to mitigate risks associated with psychotropic medications: 1) sudden cardiac events associated with high doses of the antidepressant citalopram [Celexa];5,6 and 2) impaired driving associated with zolpidem [Ambien], a sedative hypnotic medication.7,8 In this context, we will address the following three specific aims: Aim 1: To assess and describe PBM and VISN-level responsiveness and variation in responsiveness to warnings regarding psychotropic medications. Aim 2: To assess prescribing patterns before and after warnings regarding psychotropic medications. Aim 3: To understand specific strategies used by facilities and providers with high response to warnings and barriers encountered by facilities and providers with low response to warnings. Methods: Using both qualitative (using theory-driven semi-structured interviews) and quantitative methods (using surveys and administrative data), we will evaluate multiple factors that could influence facility and provider responsiveness to warnings. This study will be the first mixed methods longitudinal study of warnings for psychotropic medications in a large national health system. Aim 1 will detail the processes by which VHA prescribing policies and guidance were developed, how dissemination was accomplished, and perceived barriers and facilitators to adoption across the system, based on semi-structured interviews with national VA PBM leaders and pharmacy leaders at each VISN (N=21). Aim 2 will employ segmented regression techniques using administrative data pre- and post-warning to identify changes in psychotropic medication prescriptions and patient health monitoring in VHA by VISN and facility. Aim 3 will detail processes by which facilities and providers changed practice in response to warnings and PBM dissemination efforts. Interviews will be conducted with facility leaders (pharmacy, primary care, mental health) in Aim 3A, and surveys will be conducted with primary care providers (PCPs), and psychiatrists in Aim 3B, all of whom will be intentionally sampled based on findings from Aims 1 and 2. Methods developed and refined in this project will be applicable to a broad range of policies for mental health treatment and pharmacosurveillance. Anticipated impacts on Veterans Health: This proposal's impact derives from its ability to overcome weaknesses of previous studies by bringing together unprecedented data resources, qualitative and quantitative methods, new applications of organizational theories, and diverse investigator expertise. This work could improve clinical care and patient safety, directly benefiting VA practice and patients.