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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040217
Receipt No. R000015829
Scientific Title Development of Medical Team Coaching Program
Date of disclosure of the study information 2020/04/22
Last modified on 2020/04/22

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Basic information
Public title Development of Medical Team Coaching Program
Acronym MTCP
Scientific Title Development of Medical Team Coaching Program
Scientific Title:Acronym MTCP
Region
Japan

Condition
Condition health professions, adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 While there are various medical teams in the medical field, team coaching for medical staff is a versatile team training method for medical teams to improve team competency for any medical team.
We develop Medical Team Coaching Program for medical staff and verify its effectiveness.
Basic objectives2 Others
Basic objectives -Others Develop a program tentative plan, implement the program for multiple medical teams, evaluate before and after the program using the developed evaluation scale, qualitative survey (log at the time of program, self-administered questionnaire survey about the program and semi-structured interview survey).
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation using the medical team evaluation scale developed before, immediately after, 3-4 months after, and 6 months after the program
Key secondary outcomes Program evaluation immediately after the program by the program participants using a self-administered questionnaire survey
Program evaluation immediately after program by program participants using semi-structured interview survey
Program evaluation immediately after program by the program implementer using semi-structured interview survey
Program evaluation during program by program participants using logs
Evaluation of the program in the program by the program operator using the log

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Program for approximately 3-4 months (pre-interview, 3-4 day group session, coaching session between required sessions)
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 Those who meet all of the following

Mie University Hospital, Ichishi Hospital, Kameyama City Medical Center, Takachaya Clinic, Tsu Family Clinic, Yokkaichi Hanazu Medical Center, Nagoya Kyoritsu Hospital, Kaikoukai Rehabilitation Hospital, West Medical Center Josai Municipal Hospital, Yamatotakada Municipal Hospital, Nachikatsura Town Onsen Hospital, Saiseikai Gose Hospital, Chukyo Hospital, Shima City Hospital, Izumi Hospital (Sendai City), Akitsu Konoike Hospital, Minami Seikyo Hospital , Mizoguchi Family Clinic

health care worker

Male and female over 20 years old

As a medical team, all members wish to participate in the entire program, and after obtaining informed consent sufficient to participate in this research, all the members have given their free written consent.
Key exclusion criteria Those who the research director or co-investigators determined to be inappropriate
Target sample size 84

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Taguchi
Organization Fujita Health University
Division name Community medicine
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Pref
TEL 0562-93-2000
Email taguchi8@gmail.com

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Taguchi
Organization Fujita Health University
Division name Community medicine
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Pref
TEL 0562-93-2000
Homepage URL
Email taguchi8@gmail.com

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, Fujita University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Mie University Hospital
Address 174, Edobashi 2-chome,Tsu-shi,Mie
Tel 059-232-1111
Email kk-sien@mo.medic.mie-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2718
Org. issuing International ID_1 Mie University
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 04 Month 22 Day

Related information
URL releasing protocol https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-16K09169/
Publication of results Partially published

Result
URL related to results and publications https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-16K09169/
Number of participants that the trial has enrolled 92
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason This study was planned to be funded by KAKENHI from FY2016 to FY2018, and a team coaching program was planned to be implemented for a total of six medical teams from FY2016 to FY2018.
Securing a medical team (participants) to implement the team coaching program was the subject of this study.
By 2017, the team coaching program was planned for 4 medical teams, but it was conducted for 2 medical teams.
In FY2018, a team coaching program was carried out for six medical teams, and a total of 10 teams were carried out for a total of 6 medical teams from FY2016 to FY2018.
As data collection, we conducted interviews and questionnaires immediately after and 3 months later, but a questionnaire 6 months after the implementation is necessary for data collection. The project will be extended for one year, the data obtained will be analyzed, the results will be announced, and a paper will be submitted.
Date of the first journal publication of results
Baseline Characteristics Ichishi Hospital, Mie University Hospital, Nagoya Kyoritsu Hospital, Shima City Hospital, Izumi Hospital (Sendai City), Akitsu Konoike Hospital, Mizoguchi Family Clinic
10 medical teams (80 medical staff)
Participant flow 1 Hold briefing sessions for the team coaching program.
2 The person in charge of research or the co-workers of the research team confirms eligibility for medical teams wishing to participate in the program.
3 The principal investigator or co-investigator will obtain verbal and written consent.
4 Report to the Research Secretariat and register 8 medical teams (about 10 people per team).
5 Immediately report to the Research Secretariat if consent is withdrawn, canceled, or dropped.
Adverse events Provide sufficient explanations to the research subjects, conduct surveys and programs after obtaining voluntary consent, explain that it is possible to withdraw consent at any time in the middle, information obtained is under study Also, after the research is completed, the information will be anonymized using the correspondence table, and strict strict storage management will be done with a key locked, information access will be restricted, and anonymity will be secured when the research results are published. I am doing it as planned. As a result, no personal information was leaked from the research subjects, and no serious psychological effects were reported by implementing the team coaching program.
Outcome measures Evaluation using the medical team evaluation scale developed before, immediately after, 3-4 months after, and 6 months after the program

Program evaluation immediately after the program by the program participants using a self-administered questionnaire survey
Program evaluation immediately after program by program participants using semi-structured interview survey
Program evaluation immediately after program by the program implementer using semi-structured interview survey
Program evaluation during program by program participants using logs
Evaluation of the program in the program by the program operator using the log
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 03 Month 07 Day
Date of IRB
2014 Year 04 Month 24 Day
Anticipated trial start date
2014 Year 04 Month 24 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 04 Month 22 Day
Last modified on
2020 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015829

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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