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
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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DOI：
10.1186/s13063-019-3847-9
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发表时间：
2019-12-11
期刊：
影响因子：
2.5
通讯作者：
Furukawa, Toshi A.
中科院分区：
文献类型：
--
作者：
Seki, Tomotsugu;Aki, Morio;Furukawa, Toshi A.
背景：经典解释性随机对照试验(RCT)的缺点是推广能力有限、成本高、时间负担大。嵌套在电子健康记录(EHR)中的实用RCT有助于克服这些限制。在日本的实际实践中，血清锂监测往往没有得到充分利用。本试验旨在评价EHR套式提醒系统在维持治疗性锂浓度和改善锂维持治疗患者护理质量方面的有效性。方法：京都丰冈套式提醒对照试验(Konotori试验)是一项EHR套式、平行分组、优势、分层、排列的随机区组对照试验。筛选、随机分配、提醒输出和结果收集将由EHR嵌套试验计划自动进行。服用碳酸锂维持治疗的情绪障碍患者将被随机分配到两步提醒系统进行血清锂监测或常规护理。初步结果是在知情同意后18个月实现了治疗性血清锂浓度在0.4至1.0mEq/L之间。讨论：Konotori试验使用EHR使锂监测提醒系统的务实试验能够有效进行。这可能有助于提高锂维持疗法患者的护理质量。
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.