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：VA 处方兴奋剂 (PS) 的使用量一直在猛增。 PS对很多人都有好处 退伍军人，但也可能导致严重的风险，包括心脏问题、精神病、躁狂症、物质问题 滥用和过量。这些风险在 VA 内部或外部尚未得到充分量化，并且由于 退伍军人身体和心理健康状况不佳的比例很高，这些风险在以下人群中可能特别高 退伍军人。自 2022 年 1 月开始，PS 将成为 VA 下一个精神药物安全计划 (PDSI) 的重点。 意义：PS 是有效且有用的药物，但并非对所有患者都同样安全。这项研究将 使用 VA 庞大的全国数据库来全面量化 PS 带来的风险并识别 这些患者群体遭受不良反应的风险最大。因此，这项研究将帮助提供者决定谁 开始使用兴奋剂，以及开始后如何管理患者。由于即将推出的倡议，我们的研究 将对 VA 有所帮助，因为它致力于提高 PS 安全性，并可能对改善护理产生快速影响。 创新和影响：本研究将提供：1）首次全面审视其规模和影响 许多 PS 风险的发生频率； 2) 支持 VA 项目办公室制定质量的独特资源 改进目标并寻求在 PDSI 期间和之后改进 PS 处方实践； 3）一个 有机会确认或反驳报道的 PS 与接受治疗的患者死亡风险之间的关联 PS“标签外”； 4) 对 PS 治疗期间事件的首次系统调查，包括毒物筛查和 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 将我们的研究结果传达给医疗服务提供者，并帮助他们与患者讨论 PS 风险。 具体目标： 目标 1：识别具有 PS 特定风险的患者；目标 2：确定其他处方 PS 启动时或之后与 PS 风险增加相关的做法；目标 3：制定风险评分 (RS) 促进风险感知和协作决策：PS。 方法：本研究主要使用 VA 庞大而详细的临床数据库，并通过高水平分析 维度倾向得分和边际结构模型。这些方法有助于解决混淆问题， 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 可以快速实施以提供广泛的风险调查，使 VA 能够使用退伍军人特定的数据来 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 有关物质使用的处方和手动图表审查将增加这些 PS 风险的详细信息 评估。将通过评估已确定的风险因素来构建几种不同结果的风险评分 目标 1 和 2 加上通过迭代混合效应逻辑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，或多个结果的综合风险评分 通过项目办公室的输入，自动生成的风险评分的格式将类似于 VA 现有的 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类似地使用风险评分。 后续步骤：考虑到正在进行的 PDSI 计划，这项研究的结果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，他们拥有完善的途径 与提供商沟通。由于类似的阿片类药物工具已经很熟悉，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， 通过在 VA 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，或帮助他们的新工具。这项研究将 为改善每年接受处方兴奋剂的数千名退伍军人的护理做出贡献。