JMIR Publications

ABSTRACT

Background:

Clinical guidelines recommend regular serum lithium monitoring every 3-6 months. However, in the real world, only a minority of patients receive adequate monitoring.

Objective:

This study aims to examine whether 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.

Methods:

We conducted an open-label, 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.

Results:

A total of 111 patients were enrolled in this study. Fifty-six patients were assigned to the reminder group, and 55 to the usual care group. At the follow-up, 38 patients (69.1%) in the reminder group and 33 (60.0%) in the usual care group achieved the primary outcome (odds ratio, 2.14; 95% confidence interval [CI], 0.82 to 5.58; p = 0.12). The median number of serum lithium monitoring was two in the reminder group and zero in the usual care group (rate ratio, 3.62; 95%CI, 2.47 to 5.29, p <.0001). The exacerbation of mood disorders occurred in 17 patients (31.5%) in the reminder group and 16 (34.8%) in the usual care group (odds ratio, 0.97; 95%CI, 0.42 to 2.28, p = 0.95).

Conclusions:

We found insufficient evidence for an EHR-nested reminders to increase the achievement of therapeutic serum lithium concentrations, although the number of monitoring increased. Clinical Trial: University Hospital Medical Information Network Clinical Trials Registry UMIN000033633, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037910.