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VA response to guidance regarding risks of psychotropic medication use

VA 对精神药物使用风险指导的回应

基本信息

批准号：
8977659
负责人：
ANNE Evelyn SALES
金额：
--
依托单位：
VETERANS HEALTH ADMINISTRATION
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-10-01 至 2019-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8977659
关键词：
Address Address Adoption Adoption Affect Affect Antidepressive Agents Antidepressive Agents Cardiac Cardiac Caring Celexa Celexa Citalopram Citalopram Clinical Clinical Clinical Pharmacists Clinical Pharmacists Data Data Dose Dose Effectiveness Effectiveness Environment Event Event Future Future Goals Goals Guidelines Guidelines Health Health Health Personnel Health Personnel Health Services Health system Health system Healthcare Systems Healthcare Systems Information Systems Institute of Medicine (U.S.)Institute of Medicine (U.S.)Integrated Health Care Systems Interview Interview Knowledge Knowledge Lead Lead Learning Learning Link Link Longitudinal Studies Longitudinal Studies Medical Medical Mental Health Mental Health Methods Methods Modeling Modeling Modification Modification Monitor Monitor Myocardial Infarction Myocardial Infarction Organizational Change Organizational Change Outcome Patient Care Patient Care Patient-Focused Outcomes Patients Patients Pattern Pattern Pharmaceutical Preparations Pharmaceutical Preparations Pharmaceutical Services Pharmaceutical Services Pharmacists Pharmacists Pharmacy facility Pharmacy facility Policies Policies Primary Health Care Primary Health Care Process Process Provider Provider Psychiatrist Psychiatrist Public Health Public Health Research Personnel Research Personnel Resources Risk Risk Safety Safety Sampling Sampling Sanofi brand of zolpidem tartrate Services Services Structure Structure Surveys Surveys System System Techniques Techniques Time United States United States United States Food and Drug Administration United States Food and Drug Administration Variant Variant Veterans Veterans Work Work base base care providers clinical care clinical care clinical practice clinical practice data resource design design development policy development policy educational atmosphere evidence base evidence base health service use hypnotic hypnotic impaired driving performance impaired driving performance improved improved insight insight novel novel patient population patient population patient safety patient safety pharmacy benefit pharmacy benefit premature premature response response sedative sedative theories theories uptake uptake zolpidem zolpidem

项目摘要

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.