Department of Pharmacoepidemiology, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
J Med Internet Res. 2023 Mar 22;25:e40595. doi: 10.2196/40595.
Clinical guidelines recommend regular serum lithium monitoring every 3 to 6 months. However, in the real world, only a minority of patients receive adequate monitoring.
This study aims to examine whether the use of the electronic health record (EHR)-nested reminder system for serum lithium monitoring can help achieve serum lithium concentrations within the therapeutic range for patients on lithium maintenance therapy.
We conducted an unblinded, single-center, EHR-nested, parallel-group, superiority randomized controlled trial comparing EHR-nested reminders with usual care in adult patients receiving lithium maintenance therapy for mood disorders. The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. The key secondary outcomes are included as follows: the number of serum lithium level monitoring except for the first and final monitoring; exacerbation of the mood disorder during the study period, defined by hospitalization, increase in lithium dose, addition of antipsychotic drugs or mood stabilizers, or addition or increase of antidepressants; adherence defined by the proportion of days covered by lithium carbonate prescription during the study period.
A total of 111 patients were enrolled in this study. A total of 56 patients were assigned to the reminder group, and 55 patients were assigned to the usual care group. At the follow-up, 38 (69.1%) patients in the reminder group and 33 (60.0%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95% CI 2.47-5.29, P<.001). The exacerbation of mood disorders occurred in 17 (31.5%) patients in the reminder group and in 16 (34.8%) patients in the usual care group (odds ratio 0.97, 95% CI 0.42-2.28, P=.95).
We found insufficient evidence for an EHR-nested reminder to increase the achievement of therapeutic serum lithium concentrations. However, the number of monitoring increased with relatively simple and inexpensive intervention. The EHR-based reminders may be useful to improve quality of care for patients on lithium maintenance therapy, and they have potentials to be applied to other problems.
University Hospital Medical Information Network Clinical Trials Registry UMIN000033633; https://tinyurl.com/5n7wtyav.
临床指南建议每 3 至 6 个月定期监测血清锂水平。然而，在现实世界中，只有少数患者接受了足够的监测。
本研究旨在探讨电子病历（EHR）嵌套提醒系统用于监测血清锂是否有助于维持锂治疗的患者将血清锂浓度维持在治疗范围内。
我们进行了一项非盲、单中心、EHR 嵌套、平行组、优效性随机对照试验，比较了 EHR 嵌套提醒与常规护理在接受锂维持治疗的心境障碍成年患者中的效果。主要结局是在入组后 18 个月内达到 0.4 至 1.0mEq/L 的治疗性适当血清锂水平。主要次要结局包括以下内容：除首次和最后一次监测外的血清锂水平监测次数；研究期间心境障碍恶化，定义为住院、锂剂量增加、添加抗精神病药物或心境稳定剂、或添加或增加抗抑郁药；研究期间锂碳酸酯处方覆盖率的比例定义为依从性。
共有 111 名患者入组本研究。共有 56 名患者被分配到提醒组，55 名患者被分配到常规护理组。随访时，提醒组有 38 名（69.1%）患者和常规护理组有 33 名（60.0%）患者达到主要结局（比值比 2.14，95%CI 0.82-5.58，P=.12）。提醒组的中位数血清锂监测次数为 2 次，常规护理组为 0 次（率比 3.62；95%CI 2.47-5.29，P<.001）。提醒组有 17 名（31.5%）患者和常规护理组有 16 名（34.8%）患者出现心境障碍恶化（比值比 0.97，95%CI 0.42-2.28，P=.95）。
我们发现 EHR 嵌套提醒并不能增加治疗性血清锂浓度的达标率。然而，通过相对简单且廉价的干预措施，监测次数有所增加。基于 EHR 的提醒可能有助于改善锂维持治疗患者的护理质量，并且具有应用于其他问题的潜力。
大学医院医疗信息网络临床试验注册 UMIN000033633；https://tinyurl.com/5n7wtyav。
