UMIN-CTR Clinical Trial

Basic information
Public title	Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Acronym	Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Scientific Title	Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Scientific Title:Acronym	Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Region	Japan

Condition
Condition	Families who made a decision as a surrogate in emergency medical care center ICU.
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify experience and current condition of the families who made a decision about do not attempt resuscitation(DNAR) as a surrogate in emergency medical care center ICU.
Basic objectives2	Others
Basic objectives -Others	-
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Experience of the families who made a decision about do not attempt resuscitation(DNAR) as a surrogate in emergency medical care center ICU.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Families who made a decision about do not attempt resuscitation(DNAR) as a surrogate in emergency medical care center ICU.
Key exclusion criteria	1. The family of patient who was a victim or attempted suicide 2. The family of patient who was an infan t under the age of 15 3. The family who can't communicate in Japanese 4. The family who has problems in communicating with a researcher because of their health conditions 5. The family who shows distrust to a medical staff 6. The family who is under 20 years old 7. Judged as inappropriate participants by researcher in charge
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazuko Middle name Last name Shiraishi
Organization	Tokyo Woman's Medical University Hospital
Division name	Nursing Office
Zip code	162-8666
Address	8-1, Kawadacho,Shinjyuku-ku,Tokyo
TEL	03-3353-8111
Email	shiraishi.kazuko@twmu.ac.jp

Public contact
Name of contact person	1st name Kazumi Middle name Last name Ishizuka
Organization	Tokyo Woman's Medical University Hospital
Division name	Nursing Office
Zip code	162-8666
Address	8-1,Kawadacho,Shinjyuku-ku,Tokyo
TEL	03-3353-8111
Homepage URL
Email	kazumi.cc@tmd.ac.jp

Sponsor
Institute	Tokyo Woman's Medical University Hospital
Institute
Department

Funding Source
Organization	Tokyo Woman's Medical University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Women's Medical University Ethics Committee
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
Tel	03-3353-8111
Email	krinri.bm@twmu.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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	2016 Year 06 Month 28 Day
Date of IRB	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 07 Month 24 Day
Last follow-up date	2020 Year 03 Month 31 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 07 Month 24 Day
Last modified on	2020 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026862