UMIN-CTR Clinical Trial

Basic information
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
Condition	Nurses and care workers in a private nursing home in Japan
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	松戸ニッセイエデンの園（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
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

Progress
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
Other related information

Management information
Registered date	2016 Year 06 Month 02 Day
Last modified on	2022 Year 05 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026013