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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045135
Receipt No. R000051562
Scientific Title A study of Advance Care Planning (ACP) for elderly patients admitted urgently to the Emergency Center and ICU in Niigata Prefecture
Date of disclosure of the study information 2021/12/01
Last modified on 2021/08/12

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Basic information
Public title A survey on Advance Care Planning (ACP) for elderly patients admitted urgently to an emergency center and ICU in Niigata Prefecture
Acronym A survey on Advance Care Planning (ACP) for elderly patients admitted urgently to an emergency center and ICU in Niigata Prefecture
Scientific Title A study of Advance Care Planning (ACP) for elderly patients admitted urgently to the Emergency Center and ICU in Niigata Prefecture
Scientific Title:Acronym A study of Advance Care Planning (ACP) for elderly patients admitted urgently to the Emergency Center and ICU in Niigata Prefecture
Region
Japan

Condition
Condition Elderly patients admitted urgently to the Emergency Center or ICU in Niigata Prefecture
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the status of ACP acquisition in elderly patients admitted to emergency center and ICU in Niigata Prefecture, and to clarify the relationship between patient background, institutional factors, and social factors (urban and non-urban areas, etc.)
Basic objectives2 Others
Basic objectives -Others To determine the relationship between ACP acquisition in two periods before and after the COVID-19 pandemic in japan.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ACP-related information (whether ACP was obtained before or after hospitalization)
Key secondary outcomes Age, gender, length of stay in the Emergency Center/ICU, length of stay in the hospital, and outcome
ADL before admission, at discharge from the Emergency Center/ICU, and at discharge from the hospital
Pre-existing medical conditions
Presence of invasive treatment and its details

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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men and women aged 75 years and older who were admitted to an emergency room or ICU in Niigata Prefecture
Key exclusion criteria Patients who refused to give consent
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Natsuo
Middle name
Last name Kamimura
Organization Niigata University Medical and Dental Hospital
Division name Advanced Emergency Medicine and Critical Care Center
Zip code 951-8520
Address 754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL 025-223-6161
Email 8788kanatsu@gmail.com

Public contact
Name of contact person
1st name Natsuo
Middle name
Last name Kamimura
Organization Niigata University Medical and Dental Hospital
Division name Advanced Emergency Medicine and Critical Care Center
Zip code 951-8520
Address 754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL 070-5590-4830
Homepage URL
Email 8788kanatsu@gmail.com

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata University
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 IRB of Niigata University
Address 757 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel 025-227-2005
Email ethics@adm.niigata-u.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
2021 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participating facilities include Niigata University Medical and Dental Hospital, Niigata Prefectural Niihata Hospital, Niigata City Hospital, Japanese Red Cross Society Nagaoka Red Cross Hospital, Niigata University Regional Medical Education Center Uonuma General Hospital, and Niigata Prefectural Central Hospital.
Patients aged 75 and over who were hospitalized in an emergency will be eligible.
The period will be from October 1, 2019 to December 31, 2019 and October 1, 2020 to December 31, 2020.

Translated with www.DeepL.com/Translator (free version)

Management information
Registered date
2021 Year 08 Month 12 Day
Last modified on
2021 Year 08 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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