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

背景：锂（Li）是双相情感障碍治疗的“金标准”， 自杀然而，由于其治疗指数狭窄，Li也具有独特的危害。自杀预防 潜在的，毒性风险和监测锂已成为两个VA办公室，OMHSP和PBM的强烈关注。 这项研究建立在与OMHSP和PBM的强大合作伙伴关系的基础上，以开发一个创新的近实时系统 告知锂的处方者会急剧增加锂中毒风险的事件以及所需的监测。 方法：这项为期1年的试点研究将开发一种“锂支持系统”（或“利斯”）， CDW数据，用于跟踪和通知处方者即将进行的和过期的监测以及 临床事件是锂中毒的重要风险因素。这些临床事件是相互作用的开始， 其他提供者的药物，某些医疗疾病（肾脏问题，感染，脱水， 低钠血症），剂量增加。也许令人惊讶的是，退伍军人管理局的计算机化病历系统 （CPRS）目前在任何这些情况下都不向Li处方者提供通知。我们强大 与OMHSP的合作关系可以从他们承诺向我们提供他们拥有的代码这一事实中得到证明。 已经用来跟踪逾期的李监控。该系统将提供来自CDW的每日报告， 由中心评估员审查（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）。（在此试点中使用电子邮件而不是CPRS，以减少“警报 疲劳”，便于跟踪何时阅读通知以及处方者对通知的即时印象， 允许指导适当的临床反应）。该系统将在2个研究中心（贝德福德 波士顿VAMCs）。我们将评估过程数据（例如，生成的每种通知类型的数量，中央 评估者所需的时间、提供者响应时间）以及关于临床评估的时间和类型的图表数据。 响应（例如，教育患者有关毒性症状、保持Li、减少剂量、转换药物）。调查 及访问数据，以评估系统的可用性及可接受性。全国性数据 分析将寻求确定锂毒性的其他预测因子，以增加该系统的“第2阶段”增强 在研究的最后几个月。全国范围的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大的系统避免了这一风险，并审查毒性事件的集群。 意义：重要性：锂毒性是主要的健康问题之一，也是使用的感知障碍 这种珍贵的药物时间性：鉴于VA的激烈竞争， 减少锂中毒事件的兴趣和事实锂的使用可能会增加，由于OMHSP的努力或 大规模的李自杀预防试验接近完成。假设成本效益：该系统，如 正在开发的其他使用近实时CDW数据的中央操作工具，应能改善 VA，特别是在低性能站点，同时以可能相对较低的成本和成本的方式运行- 有效独特的范围：系统能够超越简单的监控提示，还能够警告 可能导致锂中毒的事件确实是新颖的。灵活性：该系统一旦开发，将很容易 在通知的范围和通知中包括的特定信息两者中，都是可定制的。的 我们将收集的广泛的过程、临床和可用性数据将有助于制定有关后续 实施.更广泛的实施可能包括更大的基于研究的实施， 系统的全部或部分的程序引导的实现。最终希望整个系统，甚至 可以实现进一步的扩展（例如，提供关于患者在再填充Li时失误的信息） 全国范围内。如果李成为退伍军人事务部自杀预防工作的核心，这可能会特别有帮助。 这项研究的结果将是一项迫切需要的、非常及时的、具有高度成本效益的研究， 非常强大的业务合作伙伴关系，最终可能有助于改善成千上万的退伍军人的护理。

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.