Enhancing Lithium's use in the VA through the design, initial use, and assessment of the Lithium Support System (the ELeVAte Study)

通过锂支持系统的设计、初始使用和评估，加强锂在 VA 中的使用（ELeVAte 研究）

• 批准号: 9610240
• 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: 2019
• 资助国家: 美国
• 起止时间: 2019-01-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9610240
• 关键词: Address; Admission activity; Affect; Automation; Bipolar Disorder; Boston; Brain; Caring; Cessation of life; Clinical; Code; Computerized Patient Records; Dangerousness; Data; Data Analyses; Decision Making; Dehydration; Dose; Electronic Mail; Event; Fatigue; Feedback; Frequencies; Fright; Gold; Growth; Health; Hour; Hyponatremia; Infection; Informatics; Intervention; Interview; Kidney; Kidney Failure; Lead; Lithium; Medical; Mental Health; Monitor; Notification; Output; Patient-Centered Care; Patients; Performance; Periodicity; Pharmaceutical Preparations; Phase; Pilot Projects; Prevention trial; Process; Provider; Quality Indicator; Reaction Time; Reading; Real-Time Systems; Recommendation; Reporting; Research; Risk; Risk Factors; Safety; Site; Speed; Structure; Suicide prevention; Support System; Surveys; Symptoms; System; Systems Development; Testing; Therapeutic; Therapeutic Index; Time; Titrations; Toxic effect; Update; Veterans; Voice; base; care coordination; cost effective; cost effectiveness; design; encryption; experience; field study; flexibility; hazard; implementation science; implementation strategy; impression; improved; innovation; interest; mortality; novel; prevent; programs; quetiapine; response; standard care; suicidal behavior; tool; usability; vigilance

BACKGROUND: Lithium (Li) is a “gold standard” treatment for bipolar disorder and possibly for preventing suicide. However, Li also has unique hazards due to its narrow therapeutic index. The suicide prevention potential, toxicity risk, and monitoring of Li has become an intense focus of two VA offices, OMHSP and PBM. This study builds on strong partnerships with OMHSP and PBM to develop an innovative near-real time system to inform Li prescribers of events that sharply raise the risk of Li toxicity and of needed monitoring. METHODS: This 1-year pilot study will develop a “Lithium Support System” (or “LiSS”) using near real-time CDW data to track and notify prescribers of both upcoming and past due monitoring and of the occurrence of clinical events that are powerful risk factors for Li toxicity. These clinical events are the initiation of interacting medications by other providers, certain medical illnesses (kidney problems, infections, dehydration, hyponatremia), and dose increases. Perhaps surprisingly, the VA’s computerized patient record system (CPRS) does not provide notifications currently to Li prescribers in any of these circumstances. Our strong partnership with OMHSP is evidenced by the fact that they have committed to provide us with code they have already used to track overdue Li monitoring. The system will provide daily reports from CDW which will be reviewed by a central evaluator (to prevent spurious notifications), with notifications then sent to prescribers via encrypted email (and sometimes voicemail). (Email, rather than CPRS, is used in this pilot to reduce “alarm fatigue”, facilitate tracking when notifications are read and prescribers’ immediate impressions to them, and to permit guidance about appropriate clinical responses). The system will be test implemented at 2 sites (Bedford and Boston VAMCs). We will evaluate process data (e.g., number of each notification type generated, central evaluator time required, provider response times) and chart data regarding timing and types of clinical responses (e.g., educate patient about toxicity symptoms, hold Li, decrease dose, switch medications). Survey and interview data will be used to assess the usability and acceptability of the system. Nationwide data analyses will seek to identify other predictors of Li toxicity to add to a “Phase 2” enhancement of the system introduced in the study’s final months. Nationwide data will help estimate the toxicity episodes that might be averted with broad implementation of the initial or expanded system, and examine clustering of toxicity events. SIGNIFICANCE: Importance: Li toxicity is one of the major health concerns and perceived barriers to the use of this highly valuable medication. Timeliness: Development of this system is urgent, given VA’s intense interest in reducing Li toxicity episodes and the fact Li use may increase as a result of OMHSP’s efforts or a large-scale Li suicide prevention trial approaching completion. Presumed Cost-effectiveness: This system, like the other centrally-operated tools using near-real-time CDW data being developed, should improve care across the VA, especially at low-performing sites, while operating in a manner likely to be relatively low cost and cost- effective. Unique Scope: The system’s ability to go beyond simple monitoring prompts to also warn about events that may lead to lithium toxicity is truly novel. Flexibility: The system, once developed, will be easily customizable, both in the range of the notifications and the specific information included in notifications. The wide range of process, clinical and usability data we will gather will facilitate decision-making about subsequent implementation. Broader implementation might range from larger research-based implementations to largely program-led implementations of all or part of the system. Eventually it is hoped that the whole system, or even a further expansion (e.g. providing information about patient lapses in refilling Li), could be implemented nationally. This might prove especially helpful if Li becomes a centerpiece of VA suicide prevention efforts. The result of this research will be an urgently-needed, very timely, and highly cost-effective study with extremely strong operational partnerships that may ultimately help improve care for thousands of Veterans.

背景：锂 (Li) 是治疗双相情感障碍的“金标准”，并可能用于预防 然而，由于其治疗指数狭窄，Li也具有独特的危险性。 锂的潜力、毒性风险和监测已成为两个 VA 办公室 OMHSP 和 PBM 的重点关注对象。 这项研究建立在与 OMHSP 和 PBM 的牢固合作伙伴关系的基础上，开发创新的近实时系统 告知锂处方者有关急剧增加锂中毒风险的事件以及需要进行的监测。 方法：这项为期一年的试点研究将使用近实时技术开发“锂支持系统”（或“LiSS”） CDW 数据用于跟踪并通知处方者即将进行的和逾期的监测以及发生的情况 临床事件是锂中毒的强大危险因素这些临床事件是相互作用的开始。 其他提供者提供的药物、某些医疗疾病（肾脏问题、感染、脱水、 也许令人惊讶的是，退伍军人管理局的计算机化患者记录系统。 (CPRS) 目前不会在任何这些情况下向李处方者提供通知。 与 OMHSP 的合作伙伴关系体现在他们承诺向我们提供他们拥有的代码 已用于跟踪逾期李监控 该系统将提供来自 CDW 的每日报告。 由中央评估员审查（以防止虚假通知），然后通过以下方式将通知发送给处方者： 加密电子邮件（有时是语音邮件）（本试验中使用电子邮件而不是 CPRS 来减少“警报”。 疲劳”，有助于跟踪阅读通知时的情况以及处方者对他们的即时印象，并 允许有关适当临床反应的指导）该系统将在 2 个地点（贝德福德）进行测试。 和波士顿 VAMC）我们将评估流程数据（例如，生成的每种通知类型的数量、中心数量）。 所需的评估时间、提供者响应时间）以及有关临床时间和类型的图表数据 反应（例如，教育患者有关毒性症状、停药、减少剂量、更换药物）。 访谈数据将用于评估全国数据的可用性和可接受性。 分析将寻求确定锂毒性的其他预测因子，以添加到系统的“第二阶段”增强中 研究最后几个月引入的全国数据将有助于估计可能发生的毒性事件。 通过广泛实施初始或扩展系统来避免，并检查毒性事件的聚集。 意义：重要性：锂毒性是主要的健康问题和使用障碍之一 这种非常有价值的药物的及时性：鉴于 VA 的紧张程度，该系统的开发刻不容缓。 对减少锂中毒事件的兴趣，以及由于 OMHSP 的努力或 大规模李自杀预防试验即将完成 假定的成本效益：这个系统就像。 其他使用近实时 CDW 数据的集中操作工具正在开发中，应该可以改善跨区域的护理 VA，特别是在表现不佳的地点，同时以相对较低的成本和成本- 有效范围独特：系统不仅能够提供简单的监控提示，还能够发出警告。 可能导致锂中毒的事件确实是新颖的：该系统一旦开发出来，将很容易实现。 可自定义，无论是通知范围还是通知中包含的特定信息。 我们将收集的广泛的过程、临床和可用性数据将有助于后续决策 更广泛的实施可能包括基于研究的大规模实施。 最终希望是整个系统，甚至是部分系统的方案主导的实现。 可以实施进一步的扩展（例如提供有关患者补充Li失败的信息） 如果李成为退伍军人管理局自杀预防工作的核心，这可能会在全国范围内特别有帮助。 这项研究的结果将是一项迫切需要的、非常及时且极具成本效益的研究， 极其强大的运营合作伙伴关系最终可能有助于改善对数千名退伍军人的护理。