Identifying Safe Stimulant Prescribing Practices to Protect Patients, Inform Key Program Initiatives, and Assist Providers

确定安全的兴奋剂处方实践以保护患者、为关键计划举措提供信息并协助提供者

• 批准号: 10534426
• 负责人: ERIC G. SMITH
• 金额: --
• 依托单位: EDITH NOURSE ROGERS MEMORIAL VETERANS HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10534426
• 关键词: Academic Detailing; Address; Adopted; Adoption; Adverse effects; Age; Area; Attention deficit hyperactivity disorder; Benzodiazepines; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; Cause of Death; Clinical; Clinical Practice Guideline; Counseling; Data; Data Files; Databases; Decision Making; Detection; Development; Diagnosis; Dose; Education; Event; Formularies; Frequencies; Grant; Health; Hospitalization; Hybrids; Investigation; Label; Lead; Link; Logistic Regressions; Manic; Manuals; Medicare/Medicaid; Mental Health; Methodological Studies; Methods; Modeling; Monitor; Opioid; Outcome; Overdose; Pathway interactions; Patients; Pharmaceutical Preparations; Provider; Psychoses; Psychotropic Drugs; Recording of previous events; Reporting; Research; Resources; Risk; Risk Assessment; Risk Factors; Safety; Screening Result; Signal Transduction; Stimulant; Structural Models; Substance Use Disorder; Substance abuse problem; Suicide; Suicide prevention; Sum; Surveys; Text; Time; Toxicology; Veterans; Work; adverse outcome; atomoxetine; base; clinical database; dashboard; disorder risk; follow-up; high dimensionality; high risk; high risk population; human old age (65+); hypomania; improved; innovation; medication safety; mortality; mortality risk; novel strategies; patient safety; pharmacy benefit; physical conditioning; prescription opioid; programs; random forest; risk mitigation; risk perception; risk stratification; stimulant use disorder; substance use; support tools; tool

Background: VA use of prescribed stimulants (PS) has been skyrocketing. PS are beneficial for many Veterans but can also cause serious risks ranging from cardiac problems, psychosis, mania, substance abuse, and overdose. These risks have not been well-quantified inside or outside of the VA, and because of Veterans’ high rates of physical and mental health conditions, these risks may be particularly high in Veterans. PS will be the focus of VA’s next Psychotropic Drug Safety Initiative (PDSI) starting January 2022. Significance: PS are potent and useful medications, but are not equally safe for all patients. This study will use the VA’s very large nationwide databases to comprehensively quantify the risks from PS and identify those patient groups at greatest risk of adverse effects. Thus, this study will help providers decide who to start on stimulants, and how to manage patients once started. Because of the upcoming initiative, our study will be useful to the VA as it seeks to improve PS safety and may have rapid impacts on improving care. Innovation and Impact: This study will provide: 1) the first comprehensive look at the magnitude and frequency of many PS risks; 2) a unique resource to support VA’s program offices as they set quality improvement targets and seek to improve PS prescribing practices during and after the PDSI; 3) an opportunity to confirm or refute the reported association between PS and mortality risks in patients receiving PS “off label”; 4) the first systematic investigation about events during PS treatment, including tox screens and the detection of duplicate prescriptions,that may signal increased risks for adverse effects; 5) a chart review examining whether undiagnosed substance use may contribute to PS risks; 6) development of a risk score to communicate our findings to providers, and help facilitate their discussions of PS risks with patients. Specific Aims: Aim 1: Identify Patients at Particular Risk from PS; Aim 2: Identify Other Prescribing Practices at or after PS Initiation Associated with Increased PS Risks; Aim 3: Develop Risk Scores (RS) to Facilitate Risk Perception & Collaborative Decision-Making re: PS. Methodology: This study primarily uses the VA’s large and detailed clinical databases, analyzed by high- dimensional propensity scores and marginal structural models. These methods help address confounding, which can sometimes lead to inaccurate conclusions from database information. Some of these methods also can be implemented rapidly to provide a broad survey of risks, allowing the VA to use Veteran-specific data to prioritize their safety efforts as the PDSI proceeds. Automated chart extraction concerning duplicate prescriptions and a manual chart review concerning substance use will add detail to these PS risk assessments. Risk scores for several different outcomes will be constructed by assessing risk factors identified in Aim 1 & 2 plus those identified by random forest methods by iterative mixed effects logistic regression models. The single most useful risk score, or risk score for a composite of several outcomes, will be chosen with program office input, and this automatically-generated risk score will be formatted similar to VA’s existing opioid risk score to facilitate similar use of the risk score using the program office’s clinical dashboard. Next Steps: Given the ongoing PDSI initiative, this study’s findings have the potential to immediately help Veterans through the team’s close relationship with program offices, who have well-established pathways for communicating with providers. Since a similar opioid tool is already familiar, follow-up work may include VA implementation of the risk score through a hybrid trial or, since a similar opioid tool is already in used, through widespread adoption at VA’s with pre/post data gathering concerning patient safety events. Other follow-up research may examine areas in which the PDSI did not change practices as much as expected, or develop new approaches to communicate with providers, or new tools to assist them. This study will contribute to improving care for thousands of Veterans receiving prescribed stimulants each year.

背景：退伍军人管理局处方兴奋剂（PS）的使用量一直在飙升。PS对很多人都有好处 退伍军人，但也可能导致严重的风险，从心脏问题，精神病，躁狂症，物质 滥用药物和吸毒过量这些风险在VA内部或外部都没有得到很好的量化， 退伍军人的身体和精神健康状况的高比率，这些风险可能特别高， 老兵PS将是VA下一个精神药物安全倡议（PDSI）的重点，从2022年1月开始。 重要性：PS是有效和有用的药物，但对所有患者的安全性并不相同。本研究将 使用VA非常大的全国性数据库来全面量化PS的风险， 这些患者群体的不良反应风险最大。因此，这项研究将帮助供应商决定谁 开始使用兴奋剂，以及一旦开始如何管理患者。由于即将推出的倡议，我们的研究 将有助于VA，因为它旨在提高PS安全性，并可能对改善护理产生快速影响。 创新和影响：这项研究将提供：1）第一次全面审视的规模和 许多PS风险的频率; 2）支持VA计划办公室的独特资源，因为他们设置质量 改善目标，并在PDSI期间和之后寻求改善PS处方实践; 3） 有机会证实或反驳PS与接受治疗的患者的死亡风险之间报告的相关性 PS“标签外”; 4）首次对PS治疗期间的事件进行系统性调查，包括毒理学筛查， 检测重复处方，这可能表明不良反应的风险增加; 5）图表审查 检查未确诊的物质使用是否可能导致PS风险; 6）制定风险评分， 将我们的发现传达给提供者，并帮助促进他们与患者讨论PS风险。 具体目标：目标1：识别PS的特定风险患者;目标2：识别其他处方 与PS风险增加相关的PS启动时或之后的实践;目标3：制定风险评分（RS）， 促进风险认知和协作决策re：PS. 方法：本研究主要使用VA的大型和详细的临床数据库，通过高分辨率分析， 维度倾向得分和边际结构模型。这些方法有助于解决混淆， 这有时会导致从数据库信息得出不准确的结论。其中一些方法还 可以迅速实施，以提供广泛的风险调查，使退伍军人管理局能够使用退伍军人特定的数据， 随着PDSI的进展，优先考虑他们的安全工作。关于重复的自动图表提取 处方和有关物质使用的手动图表审查将添加这些PS风险的详细信息 评估。将通过评估识别的风险因素构建几种不同结局的风险评分 在目标1和2中加上通过迭代混合效应logistic回归随机森林方法确定的那些 模型将选择单个最有用的风险评分或多个结局的复合风险评分 与程序办公室输入，这个自动生成的风险评分将格式类似于VA的现有 阿片类药物风险评分，以促进使用项目办公室的临床仪表板的风险评分的类似使用。 下一步：鉴于正在进行的PDSI计划，这项研究的发现有可能立即提供帮助 退伍军人通过团队与项目办公室的密切关系，谁拥有完善的途径， 与供应商沟通。由于类似的阿片类药物工具已经熟悉，后续工作可能包括VA 通过混合试验实施风险评分，或者，由于已经使用了类似的阿片类药物工具， 通过VA的广泛采用，收集有关患者安全事件的前后数据。其他 后续研究可能会检查PDSI没有像预期那样改变实践的领域，或者 开发与提供者沟通的新方法或协助他们的新工具。本研究将 有助于改善护理数以千计的退伍军人接受处方兴奋剂每年。