Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol

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  • Seki, Tomotsugu
    Department of Pharmacoepidemiology, Graduate School of Medicine/School of Public Health, Kyoto University
  • Aki, Morio
    Department of Psychiatry, Toyooka Hospital
  • Kawashima, Hirotsugu
    Department of Psychiatry, Toyooka Hospital･Department of Psychiatry, Kyoto University Hospital
  • Miki, Tomotaka
    Department of Psychiatry, Toyooka Hospital･Department of Psychiatry, Kyoto University Hospital
  • Tanaka, Shiro
    Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University
  • Kawakami, Koji
    Department of Pharmacoepidemiology, Graduate School of Medicine/School of Public Health, Kyoto University
  • Furukawa, Toshi A.
    Department of Health Promotion and Human Behavior, Graduate School of Medicine/School of Public Health, Kyoto University

Description

Background: The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be useful to overcome such limitations. Serum lithium monitoring has often been underutilized in real-world practice in Japan. This trial aims to evaluate the effectiveness of the EHR-nested reminder system for serum lithium level monitoring in the maintenance of therapeutic lithium concentration and in the improvement of the quality of care for patients on lithium maintenance therapy. Methods: The Kyoto Toyooka nested controlled trial of reminders (KONOTORI trial) is an EHR-nested, parallel-group, superiority, stratified, permuted block-randomized controlled trial. Screening, random allocation, reminder output, and outcome collection will be conducted automatically by the EHR-nested trial program. Patients with a mood disorder taking lithium carbonate for maintenance therapy will be randomly allocated to the two-step reminder system for serum lithium monitoring or to usual care. The primary outcome is the achievement of therapeutic serum lithium concentration between 0.4 and 1.0 mEq/L at 18 months after informed consent. Discussion: The KONOTORI trial uses EHRs to enable the efficient conduct of a pragmatic trial of the reminder system for lithium monitoring. This may contribute to improved quality of care for patients on lithium maintenance therapy. Trial registration: University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000033633. Registered on 3 July 2018.

Journal

  • Trials

    Trials 20 2019-12-11

    Springer Nature

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