UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042207 |
|---|---|
| Receipt number | R000048180 |
| Scientific Title | Timing of initial discussions of advance care planning among patients on maintenance dialysis: A cross-sectional study |
| Date of disclosure of the study information | 2020/10/22 |
| Last modified on | 2024/04/24 14:35:28 |
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Basic information
Public title
Timing of initial discussions of advance care planning among patients on maintenance dialysis: A cross-sectional study
Acronym
Timing of initial discussions of advance care planning among patients on maintenance dialysis
Scientific Title
Timing of initial discussions of advance care planning among patients on maintenance dialysis: A cross-sectional study
Scientific Title:Acronym
Timing of initial discussions of advance care planning among patients on maintenance dialysis: A cross-sectional study
Region
| Japan |
Condition
Condition
end stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to both elicit the preferences of patients on dialysis related to timing of ACP and describe the prevalence of ACP and the associated factors in this population. We will also elicit the perspectives of healthcare providers engaged in dialysis care.
Basic objectives2
Others
Basic objectives -Others
descriptive study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary study outcome is the proportion of participants whose indicate that they would consider it appropriate, a little late, or too late to conduct ACP at dialysis initiation (the first step in each trajectory)
Key secondary outcomes
Secondary outcomes will include the proportion of patients who report that they have completed ACP and whether this included discussion of preferences related to life-sustaining treatment and dialysis discontinuation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study will include patients with end-stage kidney disease (ESKD) undergoing hemodialysis or peritoneal dialysis aged 65 years or older who are within 10 years of dialysis initiation at the time of recruitment. We will exclude patients who are unwilling to participate and those who are cognitively able to provide informed consent due to moderate or severe dementia, a neurodegenerative disorder, or cerebrovascular disease.
The study will also include clinicians involved in caring for recruited patients including medical doctors, nurses, pharmacists, clinical engineers, nutritionists, and social workers.
Key exclusion criteria
as above
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamamoto |
Organization
Kyoto University
Division name
Department of healthcare epidemiology
Zip code
606-8501
Address
Sakyo-ku Yoshida konoecho, Kyoto city
TEL
075-753-4646
yamamoto.yosuke.5n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Tsujimoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of healthcare epidemiology
Zip code
606-8501
Address
Sakyo-ku Yoshida konoecho, Kyoto city
TEL
075-753-4646
Homepage URL
yssh0108@yahoo.co.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Nephrology and Hypertension, St Marianna University School of Medicine. Department of General Medicine, Shirakawa Satellite for Teaching And Research (STAR). Department of Nephrology, Inagi Municipal Hospital,
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Certified Review Board
Address
Sakyo-ku Yoshida konoecho, Kyoto city
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2020 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.protocols.io/view/timing-ofinitial-discussions-of-advance-care-plann-3byl4k3n2vo5/v1
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-024-02458-x/fulltext.html
Number of participants that the trial has enrolled
215
Results
The study involved 181 patients and 128 clinicians, with 131 patients (72%) and 84 clinicians (66%) preferring to start advance care planning when dialysis begins. Only 20 patients (11%) participated in such planning with a clinician, including 11 (6%) who discussed life-sustaining treatments and 8 (4%) who talked about continuing dialysis.
Results date posted
| 2024 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 181 patients studied, 131 (72%) were open to starting advance care planning at or before dialysis initiation while in good health. Thirteen (7%) thought this timing could be slightly late, but none found it too late. Nineteen (10%) were uncomfortable initiating planning at this stage. Discussions on planning when extremely frail were preferred by 14 patients (8%) and two clinicians (2%). Patient characteristics showed no significant correlation with preferences for proactive planning. Regarding life expectancy, 35 patients (20%) estimated less than 5 years, 50 (28%) between 5 and 10 years, 29 (16%) over 10 years, and 65 (36%) were unsure.
Participant flow
Out of 220 eligible patients on hemodialysis and 140 clinicians involved in their care, 181 patients (82%) and 128 clinicians (91%) gave informed consent and enrolled in the study.
Adverse events
none
Outcome measures
The primary outcome measured the proportion of participants who supported a proactive approach to advance care planning, categorizing their views on its timing around dialysis initiation as appropriate, a little late, or too late.
Secondary outcomes assessed the proportion of patients who had begun discussions on advance care planning with their clinicians by the time of survey completion, specifically regarding preferences for life-sustaining treatment and the continuation of dialysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048180
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