UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041532 |
|---|---|
| Receipt number | R000047252 |
| Scientific Title | Evaluation of a notification by insurer to pharmacy for patients taking multiple duplicate medications - Quadruple-Blinded, Pragmatic Cluster Randomized Trial - |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2021/01/26 13:30:57 |
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Basic information
Public title
Evaluation of a notification by insurer to pharmacy for patients taking multiple duplicate medications medications - Cluster Randomized Trial -
Acronym
Evaluation of a notification by insurer to pharmacy for patients taking multiple duplicate medications medications - Cluster Randomized Trial -
Scientific Title
Evaluation of a notification by insurer to pharmacy for patients taking multiple duplicate medications
- Quadruple-Blinded, Pragmatic Cluster Randomized Trial -
Scientific Title:Acronym
Evaluation of a notification by insurer to pharmacy for patients taking multiple duplicate medications
- Quadruple-Blinded, Pragmatic Cluster Randomized Trial -
Region
| Japan |
Condition
Condition
Medication use
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is to evaluate the efficacy of a notification by insurer to pharmacy for patients taking multiple duplicate medications and figure out a factor for changing it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement multiple duplicate medications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
sending a notification and easy questionnaire in end of August, 2020, to pharmacies in Fukuoka prefecture which are dispensing duplicate medications for their patients. Patients were detected by medical claim data from 2020/1-2020/3. The questionnaire is asking about basic information about pharmacy and a practice when patient visit pharmacy.
Interventions/Control_2
sending the same things as intervention arms in end of November, 2020.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
we recruited a pharmacy which is dispensing patients who taking multiple duplicate medications.
the inclusion criteria of patients are below,
1. 20>=, 74<=
2. visiting pharmacy in Fukuoka
3. In the same month, at least more than 3 duplicated medications which is prescribed intaking medicine over 30days and dispensed at same pharmacy. The duplication is defined by head 4 number of YJ-code (drug code in Japan)
is same in each drugs.
Key exclusion criteria
the Exclusion criteria is below,
1. prescribed and dispensed in hospital (without pharmacy), not intaking drugs.
Target sample size
4968
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
Department of Health Economics & Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Division name
Graduate School of Pharmaceutical Sciences
Zip code
1130033
Address
Hongo 7-3-1, Bunkyo-ward, Tokyo in Japan
TEL
0358414828
saito.yoshiyuki.86x@kyoto-u.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
University of Tokyo
Division name
Department of Health Economics & Outcomes Research, Graduate School of Pharmaceutical Sciences
Zip code
1130033
Address
Hongo 7-3-1, Bunkyo-ward, Tokyo in Japan
TEL
0358414828
Homepage URL
saaito.yoshiyuki.86x@kyoto-u.jp
Sponsor or person
Institute
Department of Health Economics & Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Branch of Japan Health Insurance Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Health Informatics,
Graduate School of Medicine
& School of Public Health, Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
n/a
Address
n/a
Tel
n/a
n/a
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
this trial is pragmatic trial conducted by health insurer.
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
