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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034846
Receipt No. R000039735
Scientific Title Intervention trial for prevention by multidiscipline risk management to multiple risk events among people living in geriatric health service facilities
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/10

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Basic information
Public title Intervention trial for prevention by multidiscipline risk management to multiple risk events among people living in geriatric health service facilities
Acronym Risk events prevention in GHSF
Scientific Title Intervention trial for prevention by multidiscipline risk management to multiple risk events among people living in geriatric health service facilities
Scientific Title:Acronym Risk events prevention in GHSF
Region
Japan

Condition
Condition falls, aspiration pneumonia, pressure ulcers, dehydration, and fever
Classification by specialty
Geriatrics Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect on risk event reduction such as fall, aspiration pneumonia, pressure ulcers, dehydration, and fever by Multidisciplinary Risk management
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Frequency or risk events
Reduction of risk events

Events such as falls, aspiration pneumonia, pressure ulcers, dehydration, and fever
Key secondary outcomes Number needed to treat to reduce risk events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Risk management based on multidisciplinary care-management
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 Selection of the facility
Intervention group: Facility care-worker attended the risk-management lecture and pursuit the risk-management process according to the lecture.
Control group: conventional risk management

Participants
Newly admitted elderly patients to the facilities
Key exclusion criteria When the person or proxy family did not provide written informed consent
Target sample size 6000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Okochi
Organization Association of Japanese Geriatric service facilities
Division name Permanent director
Zip code
Address Kokuryu Shibakouen building6F 2-6-15 Shibakouen Minato-ku, Tokyo 105-0011
TEL 03-3432-4165
Email Jirookochi1222@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Takano
Organization Association of Japanese Geriatric service facilities
Division name No1 Division
Zip code
Address Kokuryu Shibakouen building6F, 2-6-15 Shibakouen Minato-ku, Tokyo 105-0011
TEL 03-3432-4165
Homepage URL http://www.roken.or.jp/wp/wp-content/uploads/2012/07/H26_kinouteika_report.pdf
Email takanota@roken.or.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of health, labor and welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Healthcare Quality Assessment, The University of Tokyo,
Department of Health Policy and Management, School of Medicine, Keio University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 23
Org. issuing International ID_1 Association of Japanese Geriatric service facilities
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.roken.or.jp/wp/wp-content/uploads/2012/07/H26_kinouteika_report.pdf
Number of participants that the trial has enrolled
Results
1. Facilities with risk managers scored better than facilities without risk manager in all of the following including fully implementing R4 system (odds ratio=with risk manager 1.50, without risk manager 0.10), using the risk manual booklet published by Zenroken (odds ratio=2.26 with risk manager, 0.53 without risk manager), and implementing risk management measures at the time of care planning (odds ratio=0.85 with RM, 0.53 without risk manager).

2. Facilities following standard risk management processes (intervention group) scored better than facilities not following standard risk management processes in all of the following including fully implementing R4 system (odds ratio=intervention 2.52, non-intervention 0.08), using Risk manual booklet (odds rate = intervention 1.48, non-intervention 0.74). In short, facilities with risk manager(s), and facilities following risk management processes are providing better quality of service in terms of risk management for elderly people.

3. However we could not observe reductions in personal outcomes such as number of falls, aspiration pneumonia or pressure ulcers as a result of intervention in this study.
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 Completed
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039735

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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