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

2022 Fiscal Year Final Research Report

• Project/Area Number: 17H04122
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Epidemiology and preventive medicine
• Research Institution: Kyoto 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
• Keywords: 電子カルテ / 臨床試験 / リチウム血中濃度

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).

Free Research Field

精神医学

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