UMIN-CTR Clinical Trial

Public title

Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan

Acronym

Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan

Scientific Title

Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan

Scientific Title:Acronym

Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan

Region

Japan

Condition

Nurses and care workers in a private nursing home in Japan

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine feasibility and efficacy of an integrated care pathway for end-of-life care in a private nursing home in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Attitude of nurses and care workers toward end-of-life care;
Nurse's attitude scale on end-of-life care towards older adults and Frommelt Attitude TowardCare Of Dying scale - Form B, Japanese version

Key secondary outcomes

1.Efficacy and feasibility of ICP evaluated by semi-structured interview to nurse and care worker

2. Interdisciplinary team practice of nurses and care workers:Assessment Scale of Health Care Professionals' Recognition of a Successful Interdisciplinary Team Approach in Health Care Facilities for the Elderly

3.Efficacy and feasibility of ICP evaluated by items developed for this project

4. Efficacy and feasibility of ICP evaluated by semi-structured interview to managers

5. Feasibility of ICP evaluated by semi-structured interview to residents, families, and bereaved family

6. Administrative data of the nursing home including the number of urgent hospitalization and mortality in the institution

7. Description in daily record of nurses and care workers and in checklist including number of conferences and description in conferences

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

An complex intervention for nurses and care workers using an integrated care pathway that is developed by the authors for Japanese private nursing homes
The ICP has 5 components;
(1) Education regarding procedure of the ICP for staffs
(2) Education regarding quality EOL care for staffs
(3) Standardized multidisciplinary checklist of EOL care process
(4) Regular interdisciplinary conference
(5) Audit of description of checklist by administrator and educators in the institution

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Nurses and care workers in the facility.

Key exclusion criteria

Staff who cannot communicate in Japanese

Target sample size

50

Name of lead principal investigator

1st name	Hiroki
Middle name
Last name	Fukahori

Organization

Faculty of Nursing and Medical Care, KEIO UNIVERSITY

Division name

Devision of Gerontological nursing

Zip code

252-0883

Address

4411 Endo, Fujisawa-shi, Kanagawa

TEL

0466-49-6206

Email

fukahori@sfc.keio.ac.jp

Name of contact person

1st name	Chihiro
Middle name
Last name	Yamagata

Organization

The Jikei University

Division name

School Of Nursing

Zip code

182-8570

Address

8-3-1 Kokuryo-cho Choufu,Tokyo

TEL

03-3480-8686

Homepage URL

Email

yamagata.chihiro@jikei.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Faculty of Nursing and Medical Care, KEIO UNIVERSITY

Address

4411 Endo, Fujisawa-shi, Kanagawa

Tel

0466-49-6200

Email

nmc-hm@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

松戸ニッセイエデンの園（千葉県）

Date of disclosure of the study information

2016

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

https://www.mdpi.com/2227-9032/9/9/1194

Number of participants that the trial has enrolled

79

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

Recruitment status

Main results already published

Date of protocol fixation

2016

Year

06

Month

02

Day

Date of IRB

2016

Year

10

Month

27

Day

Anticipated trial start date

2016

Year

11

Month

02

Day

Last follow-up date

2018

Year

03

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

06

Month

02

Day

Last modified on

2022

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026013