UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050619 |
|---|---|
| Receipt number | R000057656 |
| Scientific Title | Study of Advance Care Planning by Acute Care Physician (ACP-2 study) |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2025/03/18 14:10:12 |
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Basic information
Public title
Study of Advance Care Planning by Acute Care Physician (ACP-2 study)
Acronym
ACP-2 study
Scientific Title
Study of Advance Care Planning by Acute Care Physician (ACP-2 study)
Scientific Title:Acronym
ACP-2 study
Region
| Japan |
Condition
Condition
Emergency Medicine
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the extent to which acute care physicians perform ACP.
2. To examine whether ACPs performed by acute care physicians vary by region and facility.
3. To determine whether ACPs performed by acute care physicians are related to patient satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Whether or not ACP is performed during emergency department admission.
1-1. Rate the following on a 4-point scale (If ACP was performed)
Has the surrogate decision maker been identified?
Has the patient's understanding of the disease been confirmed?
Have treatment goals been shared?
Has the patient's medical record been adequately documented?
1-2. Related items (advance directives, DNAR, DNI, BSC, etc.)
(2) Questionnaire regarding inpatient care to be administered to patients
2-1. Has there been adequate discussion between the patient and the health care provider?
2-2. Were the patient's own values shared with the medical staff?
2-3. Were the patient's wishes reflected in the treatment?
2-4. Does the patient feel satisfied with the treatment?
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
| 65 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients admitted to each facility on an emergency basis and treated primarily by acute care physicians
Key exclusion criteria
Patients who declined to participate in the study through an opt-out format
Patients deemed inappropriate by the attending physician
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Natsuo |
| Middle name | |
| Last name | Kamimura |
Organization
Niigata Univercity Medical and Dental Hospirtal
Division name
Advanced Emergency and Critical Care Center
Zip code
951-8520
Address
Asahimachido-ri 1-bannchou, 754, Niigata City, Niigata, Japan
TEL
025-223-6161
8788kanatsu@gmail.com
Public contact
Name of contact person
| 1st name | Natsuo |
| Middle name | |
| Last name | Kamimura |
Organization
Niigata Univercity Medical and Dental Hospirtal
Division name
Advanced Emergency and Critical Care Center
Zip code
951-5820
Address
Asahimachido-ri 1-bannchou, 754, Niigata City, Niigata, Japan
TEL
025-223-6161
Homepage URL
https://www.jaam.jp/info/2022/info-ACP-2_study.html
8788kanatsu@gmail.com
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
Ethics Committee of Niigata University
Address
Asahimachido-ri 1-bannchou, 757, Niigata City, Niigata, Japan
Tel
025-227-2625
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
| 2023 | Year | 08 | Month | 31 | 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
336
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will set the data collection period for eligible patients at one day to three months in the month following the completion of ethical review and study preparation at each participating site.
Management information
Registered date
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057656
