Trial Procedures and Interventions
The trial program in the EHR system automatically prompted eligibility screening when potential candidates visited the hospital and also conducted the random allocation for the consenting patients at the prespecified timing above. When the patient was enrolled and allocated to the intervention arm, the trial program printed out reminders of serum lithium monitoring to the physician, as specified by the algorithm. When a patient in the reminder group visited 4 to 8 months after the last lithium monitoring or study registration, the first reminder was sent to the physician. This reminder included the following sentence: “Please notify the patient of the serum lithium monitoring at the next visit.” When the patient visited within 8 months of the first reminder, the second reminder was sent. The second reminder included the following sentence: “Please notify the patient of the serum lithium monitoring today.” These 2-step reminders were repeated up to 2 times. When patients were allocated to the usual care group, they received the usual care without reminders. No concurrent treatments were prohibited in this trial (Illustration of KONOTORI system. EHR: electronic health record; KONOTORI: Kyoto-Toyooka nested controlled trial of reminders.