UMIN-CTR Clinical Trial

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