UMIN-CTR Clinical Trial

Basic information
Public title	Study of antipsychotic prescribing trends in a multi-modal care communication-educated healthcare facility.
Acronym	Study of antipsychotic prescribing trends in a multi-modal care communication-educated healthcare facility.
Scientific Title	Study of antipsychotic prescribing trends in a multi-modal care communication-educated healthcare facility.
Scientific Title:Acronym	Study of antipsychotic prescribing trends in a multi-modal care communication-educated healthcare facility.
Region	Japan

Condition
Condition	Behavioral and psychological symptom of dementia
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Retrospective analysis of annual trends in antipsychotic prescribing in healthcare facilities with multimodal care communication education.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Annual prescription rates of antipsychotic drugs newly prescribed to patients admitted to healthcare facilities.
Key secondary outcomes	Annual prescription costs of antipsychotic drugs newly prescribed to patients admitted to a healthcare facility.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	65 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients aged 65 years and over admitted to a healthcare facility with multimodal care communication education between 2021 to 2021.
Key exclusion criteria	Age under 65 years old
Target sample size	1600

Research contact person
Name of lead principal investigator	1st name Miwako Middle name Last name Honda
Organization	National Hospital Organization Tokyo Medical Center
Division name	Geriatric Research Division
Zip code	152
Address	2-5-1, Higashigaoka, Meguro Tokyo, Japan
TEL	0334110111
Email	honda-1@umin.ac.jp

Public contact
Name of contact person	1st name Miwako Middle name Last name Honda
Organization	National Hospital Organization Tokyo Medical Center
Division name	Geriatric Research Division
Zip code	1520021
Address	2-5-1, Higashigaoka, Meguro Tokyo, Japan
TEL	0334110111
Homepage URL
Email	honda-1@umin.ac.jp

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Tokyo Medical Center
Address	2-5-1, Higashigaoka, Meguro Tokyo, Japan
Tel	0334110111
Email	miwako.honda@tmcgrc.org

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	郡山市医療介護病院（福島県）

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 05 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	Open public recruiting
Date of protocol fixation	2022 Year 03 Month 07 Day
Date of IRB	2022 Year 03 Month 07 Day
Anticipated trial start date	2022 Year 03 Month 07 Day
Last follow-up date	2027 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The Koriyama Medical Care Hospital in Koriyama City, Fukushima Prefecture, has introduced multimodal care communication techniques as nursing and care staff education since 2014. This observational study provides observations on changes in psychotropic medication prescribed to inpatients before and after the change in staff education.

Management information
Registered date	2022 Year 04 Month 05 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054058