UMIN-ICDS Clinical Trial

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

falls, aspiration pneumonia, pressure ulcers, dehydration, and fever

Classification by specialty

Geriatrics

Nursing

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name

Organization

Ministry of health, labor and welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2018

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2018

Year

11

Month

10

Day

Last modified on

2018

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039735