Identifying Best Practices for Medication-Based Suicide Prevention Strategies to Minimize the Risk of Medically-Serious Adverse Events

确定基于药物的自杀预防策略的最佳实践，以尽量减少严重医学不良事件的风险

• 批准号: 10152372
• 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: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10152372
• 关键词: Address; Age; Antidepressive Agents; Area; Attitude; Behavior Therapy; Benefits and Risks; Caring; Characteristics; Clinical; Clozapine; Communication; Communication Tools; Control Groups; Data; Databases; Development; Diagnosis; Dose; Electronic Mail; Ensure; Formulation; Frequencies; Future; Goals; Health; Incidence; Kidney; Knowledge; Leadership; Lithium; Medical; Mental Health; Mental Health Services; Metabolic; Metformin; Methodology; Monitor; Patient Care; Patients; Pharmaceutical Preparations; Population; Predictive Analytics; Prevention strategy; Provider; Reporting; Risk; Risk Estimate; Risk Factors; Safety; Serious Adverse Event; Stratification; Structural Models; Subgroup; Suicide prevention; Surveys; Survival Analysis; Time; Veterans; Weight; behavioral health; clinical care; cohort; comparison control; dashboard; evidence base; implementation trial; improved; informant; interest; male; mortality; patient subsets; patient-clinician communication; pharmacy benefit; pilot test; policy implication; policy recommendation; predictive modeling; preference; prevent; preventive intervention; programs; provider behavior; randomized trial; response; risk minimization; risk mitigation; sex; side effect; substance use; success; suicidal behavior; tool; treatment strategy; user-friendly; willingness; ziprasidone

Background: Lithium (LI) and clozapine (CLOZ) are the most evidence-based medications for preventing fatal and nonfatal suicidal behavior (SB). Unfortunately, both medications also can cause numerous medically serious side effects (SSEs). The VA is conducting a large randomized trial of LI for SB, and VA program offices are considering encouraging greater LI and CLOZ use. This study features a comprehensive database analysis and national survey to gather data to maximize the success of any effort to expand LI and CLOZ use. Specific Aims: 1) Rapidly Assess the Current Safety of LI & CLOZ & Identify Opportunities for Expanded Use; 2) Refine Knowledge about the Timing of SSE Risks and the Implications for Clinical Care; 3) Examine Use Across Providers & Identify Perceived Barriers / Facilitators to LI and CLOZ use; and 4) Integrate Results & Develop Policy Recommendations, Provider Guide, & Communication Tool. Significance: This study will markedly advance knowledge about how to safely use LI and CLOZ. These advances will include identifying the safest populations to target for expanded use, and how to best manage patients once LI and CLOZ are started. Understanding will be obtained about barriers besides SSEs that may impede wider LI and CLOZ use, and input will be obtained from providers on how to surmount these barriers. Findings will be integrated in several ways, including synthesis into a useful guide and communication tool. Priority Area(s): Suicide Prevention, Mental & Behavioral Health, and Predictive Analytics. Uniqueness: No prior study has examined the SSEs of LI or CLOZ as comprehensively, evaluated prevention and treatment strategies as thoroughly, or condensed its findings into tools for providers and patients. Methodology: Aim 1: Cox Regressions with Propensity Scores stratification will be used to facilitate the rapid estimation of risks associated in patient groups possessing plausible SSE risks factors (e.g., particular medical, psychiatric, or substance use diagnoses). Aim 2: Cox regression with marginal structural models will evaluate the emergence and development of risks over time, seeking to identify clinically-useful “Decision Points”, and incidence rates will be derived to promote patient-provider communication regarding SSEs. Survey: A brief nationwide mental health prescriber survey focused on Barriers and Facilitators to Lithium use. Open response survey components will help ensure that any unanticipated barriers or facilitators to LI or CLOZ use will likely be identified. An all-cause mortality analysis and an example Predictive Model will help integrate results, as will an Advisory Board. A user-friendly Provider Guide and Patient-Provider Communication Tool will be developed. Expected Results: For LI and CLOZ, we expect to find some patient groups at lower risk than others for SSEs (e.g., male patients may be at lower risk for renal effects). We also expect immediate release LI to be associated with less renal risk. For CLOZ, we expect treatment of weight or metabolic risks at initiation to be beneficial. We also expect to find a “trial window” during which risks of SSEs are fairly negligible, which may increase the willingness of patients to try LI or CLOZ. We expect the survey to find that SSEs are perceived as barriers to use, but also other barriers (e.g. a preference for medications without monitoring requirements). Next Steps: The study is expected to yield immediate policy recommendations (e.g., patient groups to target or not in any prescribing initiative) and valuable tools, since results are so directly transferable to patient care. Next steps might include immediate efforts by program offices to expand Li or CLOZ use. Alternatively, an implementation trial or staggered implementation could be initiated. Pilot testing of real-time risk calculators or qualitative studies of patient, provider or other key informant attitudes towards LI and CLOZ could also occur. Other Areas: This study will also support the safe use of these uniquely-valuable medications in non-suicidal patients. The survey findings will provide data that may inform future Provider Behavior interventions.

背景：锂（Li）和氯氮平（CLOZ）是预防致命的最循证药物 和非致命自杀行为（SB）。不幸的是，两种药物也可能在医学上引起许多 严重的副作用（SSE）。 VA正在对SB进行大规模的LI随机试验和VA计划 办公室正在考虑鼓励更大的LI和CLOZ使用。该研究具有全面的数据库 分析和国家调查收集数据，以最大程度地提高扩大LI和CLOZ使用的努力的成功。 具体目的：1）快速评估Li＆Cloz的当前安全性，并确定扩大使用的机会； 2）完善有关SSE风险时机及其对临床护理的影响的知识； 3）检查使用 在提供商之间，并确定了Li和Cloz使用的感知障碍 /促进者； 4）整合结果＆ 制定政策建议，提供商指南和通信工具。 意义：这项研究将显着提高有关如何安全使用LI和CLOZ的知识。这些 进步将包括确定最安全的人群以扩展使用，以及如何最好地管理 一旦开始LI和CLOZ的患者。除了SSE之外，还将获得有关障碍的理解 阻碍更广泛的LI和CLOZ使用，并将从提供者那里获得有关如何掩盖这些障碍的信息。 调查结果将以几种方式集成，包括合成为有用的指南和通信工具。 优先区域：预防自杀，心理和行为健康以及预测分析。 独特性：没有先前的研究对LI或CLOZ的SSE进行了全面评估，预防 以及彻底的治疗策略，或将其发现变成了提供者和患者的工具。 方法学：目标1：具有倾向得分分层的COX回归将用于促进快速 估计患者群体中潜在的SSE风险因素的风险估计（例如，特定医学， 精神科或药物使用诊断）。 AIM 2：具有边际结构模型的Cox回归将评估 随着时间的流逝，风险的出现和发展，试图识别临床可用的“决策点”，以及 发病率将得出以促进有关SSE的患者提供的沟通。调查：简短 全国心理健康处方者调查的重点是锂使用的障碍和促进者。打开 响应调查组件将有助于确保任何意外的障碍或促进者使用或使用CLOZ使用 可能会被确定。全因死亡率分析和示例预测模型将有助于整合 结果，顾问委员会也是如此。用户友好的提供商指南和患者提供的沟通工具 将开发。 预期结果：对于Li和Cloz，我们希望找到某些患者群体的风险低于SSES的风险 （例如，男性患者的肾脏影响风险较低）。我们还希望立即发布李 与肾脏风险较小有关。对于CLOZ，我们预计在开始时的体重或代谢风险治疗 有利。我们还希望找到一个“试用窗口”，在此期间，SSE的风险相当可忽略，这可能 增加患者尝试LI或CLOZ的意愿。我们希望调查发现SSE被认为是 使用的障碍，也可以使用其他障碍（例如，不受监控要求的药物偏爱）。 下一步：预计该研究将产生立即的政策建议（例如，针对目标的患者群体或 没有任何规定的计划）和有价值的工具，因为结果是直接转移到患者护理中的。 下一步可能包括计划办公室的立即努力来扩展LI或CLOZ使用。或者，一个 可以启动实施试验或交错实施。实时风险计算器的试点测试或 也可能会对患者，提供者或其他关键线人参加LI和CLOZ的定性研究。 其他领域：这项研究还将支持在非杀害中安全使用这些独特的可估量药物 患者。调查结果将提供可能为未来提供者行为干预提供信息的数据。