VA response to guidance regarding risks of psychotropic medication use

 描述（由申请人提供）： 背景资料：最近美国食品和药物管理局（FDA）的警告和医学协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。这些基于证据的政策可以对公共健康和安全产生重要影响。VA药房福利管理服务（VA PBM）是我们在本研究中的主要运营合作伙伴，负责启动VA对FDA警告的响应。尽管VA PBM的使用几种方法来传达警告退伍军人综合服务网络（VISN），VA设施和供应商，很多仍然未知的多个上下文和组织因素影响响应这些警告。更好地了解VA系统和提供者层面的响应能力，可以制定和分享最佳实践，并为未来的战略提供信息，以改善警告的采用，从而改善患者护理和人群安全。 目的：鉴于相当大的VA设施水平的变化存在于精神药物处方的做法，本研究的总体目标是检查多层次的反应，外部警告有关精神药物。我们试图了解的变化，通过警告VISN，VA设施，和供应商，以及不同程度的药房整合对警告的反应的影响。我们将使用两个最近旨在降低精神药物相关风险的警告示例：1）与高剂量抗抑郁药西酞普兰[Celexa]相关的突发心脏事件; 5，6和2）与镇静催眠药唑吡坦[Ambien]相关的驾驶障碍。7，8在此背景下，我们将讨论以下三个具体目标：目标1：评估和描述PBM和VISN水平反应性以及对精神药物警告反应性的变化。目的2：评估精神药物警告前后的处方模式。目标3：了解对警告反应高的机构和提供者使用的具体策略，以及对警告反应低的机构和提供者遇到的障碍。 研究方法：使用定性（使用理论驱动的半结构化访谈）和定量方法（使用调查和管理数据），我们将评估可能影响设施和供应商对警告的响应的多个因素。这项研究将是第一个在大型国家卫生系统中对精神药物警告进行的混合方法纵向研究。目标1将详细说明制定VHA处方政策和指南的过程，如何完成传播，以及在整个系统中采用的感知障碍和促进因素，基于对每个VISN（N=21）的国家VA PBM领导人和药房领导人的半结构化访谈。目标2将采用分段回归技术，使用管理数据预警前和预警后，以确定VISN和设施在VHA中精神药物处方和患者健康监测的变化。目标3将详细说明设施和提供者根据警报和PBM传播工作改变做法的过程。将对目标3A中的机构负责人（药房、初级保健、精神卫生）进行访谈，并对目标3B中的初级保健提供者（PCP）和精神科医生进行调查，所有这些人都将根据目标1和2的结果进行有意抽样。本项目开发和完善的方法将适用于广泛的精神卫生治疗和药物监测政策。 对退伍军人健康的预期影响：该提案的影响来自于它通过汇集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多样化的研究人员专业知识来克服以前研究的弱点的能力。这项工作可以改善临床护理和患者安全，直接受益于VA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.