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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041532
Receipt No. 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 2020/08/24

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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
Email 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
Email saaito.yoshiyuki.86x@kyoto-u.jp

Sponsor
Institute Department of Health Economics & Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 24 Day
Date of IRB
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 03 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
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047252

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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