Unique ID issued by UMIN | UMIN000033633 |
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Receipt number | R000037910 |
Scientific Title | Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder |
Date of disclosure of the study information | 2018/10/01 |
Last modified on | 2023/05/10 19:00:50 |
Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder
Kyoto tOyooka Nested cOntrolled Trial Of RemInders (KONOTORI) Study
Pragmatic Randomized Controlled Trial of Electronic Health Record-based Reminder System to Measure Serum Lithium Levels among Patients with Mood Disorder
Kyoto tOyooka Nested cOntrolled Trial Of RemInders (KONOTORI) Study
Japan |
Bipolar disorder and major depressive disorder
Psychiatry |
Others
NO
To evaluate the efficacy of electric health record-based reminder system to measure serum lithium levels
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The proportion of patients with serum lithium level between 0.4 and 1.0 mEq/l between 18 and 24 months after inclusion
1) Number of tests of serum lithium level within 18-24 months after inclusion
2) Exacerbation of mood disorder including admission, a dose increase of lithium, an addition of antipsychotics, antidepressants or mood stabilizers
3) The proportion of days when lithium was prescribed during the study period
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Medicine | Other |
Reminders of blood test of serum lithium levels per every 6 months
Standard care
18 | years-old | <= |
Not applicable |
Male and Female
1) Bipolar disorder or major depressive disorder according to DSM-5
2) Taking lithium carbonate longer than six months
3) Need to continue lithium carbonate over 18 months (as judged by treating psychiatrist)
1) Prescribed lithium for a condition other than mood disorder
2) Who did not provide written informed consent
3) Schizophrenia
4) Inappropriate/unable to participate in the trial (as judged by treating psychiatrist)
5) Serious suicide intent (as judged by treating psychiatrist)
6) Lithium intoxication
7) Pregnancy
8) Researcher of the trial and their family
9) Who cannot read Japanese
10) Contraindication of lithium
11) Participation in another clinical trial
12) Inpatients
13) End-stage physical disease
14) Who did not have serum lithium level measurement at baseline
15) Who did not visit hospital between 4-8 months after inclusion
120
1st name | Toshi A. |
Middle name | |
Last name | Furukawa |
Graduate School of Medicine and Public Health, Kyoto University
Department of Health Promotion and Human Behavior
606-8501
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
075-753-9491
Cbm.kusph@gmail.com
1st name | Tomotsugu |
Middle name | |
Last name | Seki |
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Department of Cardiovascular Medicine
602-8566
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
075-251-5511
tseki@koto.kpu-m.ac.jp
Graduate School of Medicine and Public Health, Kyoto University
Japan Society for the Promotion of Science
Japanese Governmental office
Toyooka Hospital
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital, Ethics Comittee
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
075-753-4642
ethcom@kuhp.kyoto-u.ac.jp
NO
公立豊岡病院 (兵庫県)
2018 | Year | 10 | Month | 01 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/31829279
Published
doi:10.2196/40595
111
At the follow-up, the difference in the primary outcome (the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment) was not statistically significant between the reminder group and the usual care group. The median number of serum lithium monitoring was significantly higher in the reminder group than in the usual care group. The exacerbation of mood disorders was similar between two groups.
2023 | Year | 05 | Month | 10 | Day |
2023 | Year | 03 | Month | 22 | Day |
A total of 48% of the patients had bipolar I disorder, 36% had bipolar II disorder, and 26% had recurrent major depression. The mean age of patients was 57 years, and 42.7% were men. The mean baseline lithium level was 0.61 mEq/L, and 73.6% of patients had lithium levels within the therapeutic range.
Trial enrollment started on November 1, 2018, and ended on March 31, 2020. We continued the follow-up until September 10, 2021. Of 167 patients who underwent screening, 56 were excluded (Figure 2) and 111 underwent randomization. Of them, 56 patients were randomly assigned to receive EHR-nested reminders (reminder group), and 55 received usual care (usual care group). One patient in the reminder group withdrew consent after randomization, and the remaining 110 patients were analyzed.
The mean serum eGFR and TSH levels were similar between the 2 groups (Table 2). One patient in the intervention group discontinued lithium carbonate owing to lithium intoxication,
and 1 patient in the usual care group temporarily discontinued but restarted it thereafter. One patient in the intervention group and 2 patients in the usual care group died for reasons unrelated to mood disorders, including suicide.
The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. 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). The exacerbation of mood disorders occurred in 17 (31.5%) patients in the reminder group and in 16 (34.8%) patients in the usual care group (odds ratio 0.97, 95% CI 0.42-2.28, P=.95).
Main results already published
2018 | Year | 07 | Month | 20 | Day |
2018 | Year | 09 | Month | 26 | Day |
2018 | Year | 11 | Month | 01 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 10 | Month | 31 | Day |
2021 | Year | 11 | Month | 30 | Day |
2021 | Year | 12 | Month | 31 | Day |
2018 | Year | 08 | Month | 06 | Day |
2023 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037910
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