• Search Research Projects
  • Search Researchers
  • How to Use
  1. Back to previous page

EHR-nested pragmatic clinical trial: Development of a system and conducting the trial

Research Project

Project/Area Number 17H04122
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Research Field Epidemiology and preventive medicine
Research InstitutionKyoto University

Principal Investigator

Furukawa Toshiaki  京都大学, 医学研究科, 教授 (90275123)

Co-Investigator(Kenkyū-buntansha) 川上 浩司  京都大学, 医学研究科, 教授 (70422318)
渡辺 範雄  京都大学, 医学研究科, 客員研究員 (20464563)
Project Period (FY) 2017-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2022)
Budget Amount *help
¥15,470,000 (Direct Cost: ¥11,900,000、Indirect Cost: ¥3,570,000)
Fiscal Year 2021: ¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2020: ¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2019: ¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2018: ¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2017: ¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000)
Keywords電子カルテ / 臨床試験 / リチウム血中濃度 / 無作為割り付け比較試験 / リチウム血中濃度測定 / 気分障害 / 臨床疫学
Outline of Final Research Achievements

To test the feasibility of the electronic health record-nested pragmatic trial, we conducted an unblinded, 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. 111 patients were enrolled, of whom 56 patients were assigned to the reminder group, and 55 patients were assigned to the usual care group.. At the follow-up, 38 (69.1%) patients in the reminder group and 33 (60.0%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95% CI 2.47-5.29, P<.001).

Academic Significance and Societal Importance of the Research Achievements

(1) 本邦の精神科日常臨床における電子カルテシステムを利用したランダム化比較試験の実施可能性が確認された
(2) 電子カルテシステムを利用した担当医へのリチウム血中濃度採血のリマインドは、血清濃度測定回数を増やすことは確認できたが、炭酸リチウム内服中の気分障害患者のリチウム有効血中濃度の達成ならびに臨床的アウトカムに影響を与えるというエビデンスは得られなかった
今後、Every clinical encounter will be an opportunity to advance medicine and healthcareための実践的臨床試験が広がることが期待される

Report

(6 results)
  • 2022 Final Research Report ( PDF )
  • 2021 Annual Research Report
  • 2020 Annual Research Report
  • 2019 Annual Research Report
  • 2018 Annual Research Report
  • 2017 Annual Research Report
  • Research Products

    (2 results)

All 2023 2019

All Journal Article (2 results) (of which Peer Reviewed: 2 results,  Open Access: 2 results)

  • [Journal Article] Electronic Health Record?Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial2023

    • Author(s)
      Seki T, Aki M, Furukawa TA, Kawashima H, Miki T, Sawaki Y, et al.
    • Journal Title

      Journal of Medical Internet Research

      Volume: 25 Pages: e40595-e40595

    • DOI

      10.2196/40595

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol2019

    • Author(s)
      Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami, Toshi A. Furukawa.
    • Journal Title

      Trials

      Volume: 20 Issue: 1 Pages: 706-706

    • DOI

      10.1186/s13063-019-3847-9

    • NAID

      120006848249

    • Related Report
      2019 Annual Research Report 2018 Annual Research Report
    • Peer Reviewed / Open Access

URL: 

Published: 2017-04-28   Modified: 2024-01-30  

Information User Guide FAQ News Terms of Use Attribution of KAKENHI

Powered by NII kakenhi