UMIN-CTR Clinical Trial

Basic information
Public title	Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research
Acronym	Advance Care Planning conducted by non-physician providers in Japanese primary care clinics
Scientific Title	Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research
Scientific Title:Acronym	Advance Care Planning conducted by non-physician providers in Japanese primary care clinics
Region	Japan

Condition
Condition	N/A
Classification by specialty	Medicine in general Geriatrics Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this evaluation is to establish an understanding of a practical way of ACP by non-physician providers in Japanese primary care clinics, including (1) Feasibility of ACP conducted by non-physician providers; and (2) Effective timing to conduct ACP systematically in busy workflow.
Basic objectives2	Others
Basic objectives -Others	Feasibility
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We will assess feasibility of ACP conducted by non-physician providers in Japanese primary care clinics by data from semi-structured interview and questionnaire.
Key secondary outcomes	We will assess effective timing to conduct ACP systematically in busy workflow by data from semi-structured interview and questionnaire.

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	Other
Interventions/Control_1	We will train non-physician providers to be ACP facilitators. They will facilitate ACP for patients who are willing to discuss future medical care.
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	We will include patients who are willing to discuss future medical care, such as patients at the time of getting an opinion letter for LTC insurance, at the time of discharge and at the time of transition to regularly home visit use.
Key exclusion criteria	We will exclude patients who cannot express their thoughts.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Mochizuki
Organization	Japan Association for Development of Community Medicine (JADECOM)
Division name	Institute of Community Medicine
Zip code	1020093
Address	2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
TEL	03-5212-9152
Email	t-mochizuki@jadecom.or.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Horie
Organization	Japan Association for Development of Community Medicine
Division name	Institute of Community Medicine
Zip code	1020093
Address	2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
TEL	03-5212-9152
Homepage URL
Email	hhorie@jadecom.jp

Sponsor
Institute	Japan Association for Development of Community Medicine (JADECOM)
Institute
Department

Funding Source
Organization	Japan Association for Development of Community Medicine (JADECOM)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Oregon Health & Science University Department of Family Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	JADECOM IRB
Address	2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
Tel	03-5212-9152
Email	hhorie@jadecom.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	東通村診療所(青森県)、久瀬診療所(岐阜県)、西浅井地区診療所(滋賀県)、都祁診療所(奈良県)、

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 12 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	Completed
Date of protocol fixation	2018 Year 12 Month 06 Day
Date of IRB	2018 Year 12 Month 06 Day
Anticipated trial start date	2019 Year 02 Month 12 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 12 Day
Last modified on	2019 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040710