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：锂盐（LI）和氯氮平（CLOZ）是预防致命性精神分裂症的最循证药物。 非致命性自杀行为（SB）不幸的是，这两种药物也可以导致许多医疗 严重副作用（SSE）。VA正在进行一项针对SB的LI的大型随机试验，VA计划 各办事处正在考虑鼓励更多地使用LI和CLOZ。这项研究的特点是全面的数据库 分析和全国调查，以收集数据，最大限度地扩大LI和CLOZ使用的任何努力的成功。 具体目标：1）快速评估LI和CLOZ目前的安全性并确定扩大使用的机会; 2)完善有关SSE风险发生时间的知识以及对临床护理的影响; 3）检查使用情况 跨提供者和识别LI和CLOZ使用的感知障碍/促进者;以及4）整合结果和 制定政策建议、提供商指南和沟通工具。 意义：本研究将显著提高关于如何安全使用LI和CLOZ的知识。这些 进展将包括确定扩大使用的最安全人群，以及如何最好地管理 患者一旦开始LI和CLOZ。将了解除了SSE之外的障碍， 阻碍LI和CLOZ更广泛的使用，将从提供商那里获得关于如何克服这些障碍的投入。 将以多种方式整合调查结果，包括将其综合成一个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。 唯一性：之前没有研究将LI或CLOZ的SSE作为全面评估的预防进行检查 和治疗策略，或者将其发现浓缩成供提供者和患者使用的工具。 方法：目的1：将使用考克斯回归和倾向评分分层，以促进快速 估计与具有合理SSE风险因素的患者组相关的风险（例如，特别是医学， 精神病或物质使用诊断）。目标2：采用边际结构模型的考克斯回归将评估 随着时间的推移，风险的出现和发展，寻求识别临床有用的“决策点”，以及 将推导出发生率，以促进患者与提供者之间关于SSE的沟通。调查：简短 全国心理健康处方者调查重点是锂使用的障碍和促进因素。开放 响应调查部分将有助于确保LI或CLOZ使用的任何意外障碍或促进因素 很可能会被识别。全因死亡率分析和示例预测模型将有助于整合 结果，咨询委员会也是如此。用户友好的提供者指南和患者-提供者沟通工具 将被开发。 预期结果：对于LI和CLOZ，我们预计会发现某些患者组的SSE风险低于其他患者组 (e.g.,男性患者的肾脏影响风险可能较低）。我们还希望立即释放李， 与较低的肾脏风险相关。对于CLOZ，我们预计在开始时治疗体重或代谢风险， 有利于我们还希望找到一个“试验窗口”，在此期间，SSE的风险相当可以忽略不计，这可能 增加患者尝试LI或CLOZ的意愿。我们预计调查会发现， 使用障碍，以及其他障碍（例如，偏好没有监测要求的药物）。 下一步：预计研究将立即产生政策建议（例如，目标患者群体或 没有在任何处方倡议）和有价值的工具，因为结果是如此直接地转移到病人护理。 下一步可能包括项目办公室立即努力扩大Li或CLOZ的使用。选择是另加设置一 可以开始试行或交错实施。实时风险计算器的试点测试，或 还可以对患者、提供者或其他关键知情者对LI和CLOZ的态度进行定性研究。 其他领域：这项研究也将支持这些有价值的药物在非自杀性疾病中的安全使用。 患者调查结果将提供数据，可能会告知未来的供应商行为干预。