UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040217
Receipt number 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 14:00:46

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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 or person

Institute

Fujita Health University

Institute

Department

Personal name



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

Value
https://center6.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