UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038916 |
|---|---|
| Receipt number | R000044371 |
| Scientific Title | Group-based educational intervention for advance care planning in primary care: a quasi-experimental study in Japan |
| Date of disclosure of the study information | 2019/12/17 |
| Last modified on | 2019/12/17 19:12:28 |
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Basic information
Public title
Group-based education for advance directives and advance care planning
Acronym
Group-based education for advance directives and advance care planning
Scientific Title
Group-based educational intervention for advance care planning in primary care: a quasi-experimental study in Japan
Scientific Title:Acronym
Group-based educational intervention for advance care planning in primary care: a quasi-experimental study in Japan
Region
| Japan |
Condition
Condition
Non-cancer chronic diseases
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether a video-supported group-formatted advance care planning program for older primary care patients with stable medical conditions results in a better advance directive completion rate and a greater likelihood of familial discussions regarding advance care planning compared to an individual discussion with a physician
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Advance directive completion
Key secondary outcomes
Familial discussion
Satisfaction with the discussion session
Perceptions and attitudes about advance care planning
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An educational video and brochure on advance care planning and advance directives were offered to all participants in the study. Then, participants in the intervention arm attended a 60-minute group discussion with other participants, which was facilitated by one of the study investigators. The group discussion addressed preferences about medical care at the end of life and the purpose of advance care planning. After the discussion, the participants were tracked for a period of time during which two regular visits to their attending physician were made. Their physicians allocated time for answering questions about the advance care planning if it was needed.
Interventions/Control_2
After watching the video, participants in the control arm engaged in a 20-minute individual discussion with their primary care physician on the same discussion topics. After the discussion, the follow-up visits were done in the same manner as those for participants in the intervention arm.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible participants were adult patients aged 65 years or older who regularly visited an assigned physician in the trial site for chronic illness care. They were required to have seen their physicians more than three times and to be legally competent.
Key exclusion criteria
Those who had already completed advance directives or living wills were ineligible for this study. Those who regularly visited another physician of any specialty were also excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Tsuda |
Organization
Kikugawa Family Medicine Center
Division name
Medical Department
Zip code
437-1507
Address
1055-1 Akatsuchi, Kikugawa, Shizuoka
TEL
0537-73-2267
syu-net@ba3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Tsuda |
Organization
Kikugawa Family Medicine Center
Division name
Medical Department
Zip code
437-1507
Address
1055-1 Akatsuchi, Kikugawa, Shizuoka
TEL
0537-73-2267
Homepage URL
syu-net@ba3.so-net.ne.jp
Sponsor or person
Institute
Kikugawa Family Medicine Center
Institute
Department
Personal name
Funding Source
Organization
None
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 Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.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
菊川市家庭医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.hama-med.ac.jp/research/clinical-res/erc/index.html
Publication of results
Unpublished
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201402225778227537&rel=1#%7B%22category%22%3A%220%22%2C%
Number of participants that the trial has enrolled
109
Results
Advance directive completion rates were high for both group and individual arms but did not significantly differ between arms (85.7% vs. 80.4%, p=0.45). Only one-fifth of patients in both arms discussed advance care planning with their family after the intervention (20.7% and 21.7%, p=0.89). Patients in the group arm rated their experience slightly higher than those in the individual arm (4.2 and 3.9 out of 5, p=0.023).
Results date posted
| 2019 | Year | 12 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants' mean age was 76.1 in the group arm and 78.8 in the individual arm. Most of them perceived their health status as good or excellent (88.8% and 73.9%, respectively). Only 11.5% and 13.0% of the participants in each arm were familiar with advance directives before the intervention.
Participant flow
A total of 133 eligible older adults were invited to participate. Of them, 109 agreed to participate, with 63 assigned to the group arm and 46 to the individual arm. After the allocation, three and two participants in the group and individual arms, respectively, did not attend the discussion session, and three and nine, respectively, did not complete the second questionnaire after engaging in their allocated discussion session.
Adverse events
None
Outcome measures
Advance directive completion
Familial discussions
Satisfaction with the discussion sessions
Perceptions and attitudes about advance care planning
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044371
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