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) 是预防致命性死亡的最有证据依据的药物 不幸的是，这两种药物也会导致许多医学问题。 VA 正在针对 SB 和 VA 计划进行一项大型随机试验。 各办公室正在考虑鼓励更多地使用 LI 和 CLOZ。这项研究以综合数据库为特色。 分析和全国调查来收集数据，以最大限度地扩大 LI 和 CLOZ 使用的努力取得成功。 具体目标： 1) 快速评估 LI 和 CLOZ 当前的安全性并确定扩大使用的机会； 2) 完善有关 SSE 风险的发生时间及其对临床护理的影响的知识 3) 检查使用情况； 跨提供商并识别 LI 和 CLOZ 使用的感知障碍/促进因素；4) 整合结果； 制定政策建议、提供商指南和沟通工具。 意义：这项研究将显着增进有关如何安全使用 LI 和 CLOZ 的知识。 进展将包括确定最安全的人群以扩大使用，以及如何最好地管理 一旦 LI 和 CLOZ 开始，患者将了解除 SSE 之外可能存在的障碍。 阻碍更广泛的 LI 和 CLOZ 使用，并且将从提供商那里获得关于如何克服这些障碍的意见。 研究结果将以多种方式整合，包括综合成有用的指南和交流工具。 优先领域：自杀预防、心理和行为健康以及预测分析。 独特性：之前没有研究将 LI 或 CLOZ 的 SSE 作为全面、评估的预防进行检验 和治疗策略进行彻底的研究，或者将其研究结果浓缩成供提供者和患者使用的工具。 方法：目标 1：带有倾向得分分层的 Cox 回归将用于促进快速 估计具有合理 SSE 风险因素的患者群体的相关风险（例如，特定的医疗、 目标 2：使用边际结构模型进行 Cox 回归评估 随着时间的推移风险的出现和发展，寻求确定临床上有用的“决策点”，以及 将得出发病率，以促进患者与提供者有关 SSE 的沟通：调查简介。 全国心理健康处方者调查重点关注锂使用的障碍和促进因素。 响应调查的组成部分将有助于确保 LI 或 CLOZ 使用的任何意外障碍或促进因素 可能会确定全因死亡率分析和示例预测模型将有助于整合。 结果，以及用户友好的提供者指南和患者与提供者沟通工具。 将被开发。 预期结果：对于 LI 和 CLOZ，我们预计某些患者群体的 SSE 风险低于其他患者群体 （例如，男性患者出现肾脏影响的风险可能较低）。我们还预计立即释放 LI 是可能的。 对于 CLOZ，我们预计治疗开始时应针对体重或代谢风险进行治疗。 我们还期望找到一个“试验窗口”，在此期间上证所的风险可以忽略不计。 提高患者尝试 LI 或 CLOZ 的意愿。我们希望调查发现 SSE 被认为是 使用障碍，还有其他障碍（例如偏爱没有监测要求的药物）。 后续步骤：预计该研究将立即产生政策建议（例如，目标患者群体或 不在任何处方计划中）和有价值的工具，因为结果可以直接转移到患者护理中。 下一步可能包括项目办公室立即努力扩大 Li 或 CLOZ 的使用。 可以启动实时风险计算器的实施试验或分阶段实施。 还可以对患者、提供者或其他关键知情人对 LI 和 CLOZ 的态度进行定性研究。 其他领域：这项研究还将支持在非自杀患者中安全使用这些独特有价值的药物 调查结果将提供可为未来提供者行为干预提供信息的数据。