Electronic Health Record-Nested Pragmatic Randomized Controlled Trial in Psychiatry and Cardiology

2023 Fiscal Year Final Research Report

• Project/Area Number: 19K10509
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 58010:Medical management and medical sociology-related
• Research Institution: Kyoto Prefectural University of Medicine (2021-2023); Kyoto University (2019-2020)
• Principal Investigator: Seki Tomotsugu 京都府立医科大学, 医学(系)研究科(研究院), 特任助教 (30837894)
• Co-Investigator(Kenkyū-buntansha): 川上 浩司 京都大学, 医学研究科, 教授 (70422318) ; 古川 壽亮 京都大学, 医学研究科, 教授 (90275123)
• Project Period (FY): 2019-04-01 – 2024-03-31
• Keywords: ランダム化比較試験 / Electronic Health Record / 気分障害 / 循環器内科

Outline of Final Research Achievements

We developed a computer system using electronic health records (EHR) to automate screening, randomization, intervention, and data collection in randomized controlled trials (RCTs). We conducted a single-center, open-label, parallel-group pragmatic RCT to show the effectiveness of reminders for serum lithium monitoring in patients with mood disorders on lithium maintenance therapy. This simple and inexpensive EHR-based reminders did not increase the achievement of the primary outcome (target serum lithium concentrations), while it did increase the number of serum lithium monitoring. This EHR-nested system was useful for improving the quality of care in psychiatry, and may be applicable to other clinical settings. In addition, we are planning to conduct the next pragmatic RCT in cardiology based on findings of our preliminary studies.

Free Research Field

臨床疫学

Academic Significance and Societal Importance of the Research Achievements

EHRを用いたリマインドという比較的単純で安価な介入は、血清リチウム濃度の目標血中濃度の達成を増加させなかったが、一方で血清リチウムのモニタリング回数を有意に増加させた。本介入はリチウム維持療法を受けている気分障害を有する成人患者の診療の質を改善するのに有用であり、他の課題にも応用できる可能性がある。また循環器内科領域において実施した複数の予備的研究をもとに、今後循環器内科領域でも同様のpragmatic RCTの実施を予定している。