Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000150640
Ethics application status
Approved
Date submitted
31/01/2023
Date registered
16/02/2023
Date last updated
16/02/2023
Date data sharing statement initially provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and evaluation of a conflict management workshop for medical students
Scientific title
This study aims to develop and evaluate a conflict management workshop for final year medical students.
Secondary ID [1] 308624 0
Nil known
Universal Trial Number (UTN)
U1111-1286-1319
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Experiences of workplace conflict 328523 0
Mental effects of experiencing workplace conflict 328524 0
Physical effects of experiencing workplace conflict 328945 0
Emotional effects of experiencing workplace conflict 328946 0
Condition category
Condition code
Mental Health 325541 325541 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A random sample of students from the enrolled Doctor of Medicine Year 4 (MD4) cohort will be invited to take part in the study. The study will start with an online survey developed for this study directed at collecting demographic data, estimates of the frequency and degree of conflict experienced whilst on placement, and information about the extent to which these experiences affect the participant. It will also ask for a self-assessment of comfort and competence in dealing with conflict using Likert scales. It will use validated tools to measure baseline empathy, emotional intelligence, and conflict style. The survey will be administered through a link sent to the student's student email address. The surveys will take a total of approximately 15-20 minutes to complete. This data will be used to develop a four-part workshop on conflict resolution that addresses the needs of the cohort, drawing from a range of published/ well-recognised conflict management tools listed in the study proposal. The study will progress to an unblinded randomised controlled design, with the students who have done the survey being randomised into an intervention group and a control group.

The intervention group will be invited to participate in four face to face workshops lasting up to 4 hours each, delivered by the members of the faculty who are experienced in workshop facilitation and have prior training and experience in each of the key areas (leadership, conflict, emotional intelligence). These will take place on the university campus.
The workshops will be face to face and are likely to be interactive and involve role-playing activities with actors. The exact content of them and therefore how they are run will be determined by the survey results, so it is not possible to outline it at this time. The participants will not be involved in working groups, further interviews, or intervention design, however 2 members of the research team have just graduated from MD4 and will provide input.

The workshop will be developed by the research team lead by Dr Kate Jutsum, and delivered by various members of the research team (who have experience in various of the related fields), and by external providers where necessary (for example, specific agencies who are able to supply actors, or have specialist training in areas that are highlighted in the survey as deficient, e.g. Emotional Intelligence). We expect to begin workshop development by the end of March (the surveys being completed by mid-March), and deliver the workshops in May-June. The students will be able to choose from workshops run at various times to suit their schedules. Attendance registers will be kept for all workshops.

Examples of possible workshop content include:
- For Emotional Intelligence (EI), simulation activities in which the student plays the patient, or structured education sessions in which the student receives feedback on their own assessed EI and how this could be strengthened
- For Personal Wellbeing, a workshop on stress management
- For Interpersonal relationships, and teamwork, simulation activities that involve interprofessional learning
- For communication skills, a workshop on non-verbal communication.
Intervention code [1] 325075 0
Behaviour
Intervention code [2] 325076 0
Lifestyle
Intervention code [3] 325077 0
Treatment: Other
Comparator / control treatment
The control group progresses through the usual medical curriculum. They will receive access to their personalised survey results and all of the workshop content once the study is complete in December 2023.
Control group
Active

Outcomes
Primary outcome [1] 333383 0
Change in reported confidence in handling conflict immediately and at 6 months post-intervention.
This data will be collected using a survey designed for this study.
Timepoint [1] 333383 0
6 months post-intervention
Primary outcome [2] 333780 0
Change in reported competence in handling conflict immediately and at 6 months post-intervention.
This data will be collected using a survey designed for this study,
Timepoint [2] 333780 0
6 months post-intervention
Secondary outcome [1] 416870 0
Change in objective scores of empathy
The Empathy Quotient is a validated tool that will be used to collect this data.
Timepoint [1] 416870 0
6 months post- intervention
Secondary outcome [2] 418281 0
Change in objective scores of emotional intelligence (EI)
The Workgroup Emotional Intelligence Profile - Short version (WEIP-S) is a validated tool that will be used to assess EI.
Timepoint [2] 418281 0
6 months post-intervention
Secondary outcome [3] 418528 0
Percentage of students who have personally experienced workplace conflict whilst on placement.
Assessed using survey developed for the study. Actual prevalence figures will be used to fine tune the RCT sample sizes, as anticipated prevalence is currently being extrapolated from non-medical student sources.
Timepoint [3] 418528 0
At time of initial survey
Secondary outcome [4] 418530 0
Percentage of students who have witnessed workplace conflict whilst on placement.
Assessed using survey developed for the study.
Timepoint [4] 418530 0
At time of initial survey
Secondary outcome [5] 418531 0
Qualitative evaluation of the way in which witnessed or experienced conflict has affected participants.
Assessed using free text qualitative questions in survey developed for the study.
Timepoint [5] 418531 0
At time of initial survey

Eligibility
Key inclusion criteria
Participants will be drawn from the enrolled University of Western Australia (UWA) Doctor of Medicine year 4 (MD4) cohort of 2023. The entire cohort will be listed in alphabetical order in Excel, then allocated a number using Excel random number generation, and reordered according to that number. The first 100 of the cohort by allocated number will then be invited to participate in the study.
There are no additional inclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include inability to attend the proposed training, not having completed Doctor of Medicine Year 3 (MD3) at UWA during 2022, anticipated inability to complete all Integrated Medical Practice 3 rotations over the course of 2023, unwillingness to undergo psychometric testing, lack of informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For this study, an estimated sample size of 112 students will be needed. This is based off an expected year-group population of 200. The prevalence of experienced workplace conflict amongst medical students is not known, but studies in similar populations report 71%, which was used to calculate sample size. This will be fine-tuned as necessary using actual prevalence data from the intake survey for this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2023
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 312863 0
University
Name [1] 312863 0
University of Western Australia
Country [1] 312863 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Medical School
2nd Floor Harry Perkins
6 Verdun Street
Nedlands
WA
6009
Country
Australia
Secondary sponsor category [1] 314522 0
None
Name [1] 314522 0
Address [1] 314522 0
Country [1] 314522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312140 0
Human Research Ethics Office, UWA
Ethics committee address [1] 312140 0
Ethics committee country [1] 312140 0
Australia
Date submitted for ethics approval [1] 312140 0
13/11/2022
Approval date [1] 312140 0
17/11/2022
Ethics approval number [1] 312140 0
2022/ET000929

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123622 0
Dr Kate Jutsum
Address 123622 0
Medical School
2nd Floor Harry Perkins North
6 Verdun Street
Nedlands
WA
6009
Country 123622 0
Australia
Phone 123622 0
+61 0864572325
Fax 123622 0
Email 123622 0
[email protected]
Contact person for public queries
Name 123623 0
Kate Jutsum
Address 123623 0
University of Western Australia Medical School
2nd floor, Harry Perkins North
6 Verdun St
Nedlands
WA
6009
Country 123623 0
Australia
Phone 123623 0
+61 0861511107
Fax 123623 0
Email 123623 0
[email protected]
Contact person for scientific queries
Name 123624 0
Kate Jutsum
Address 123624 0
University of Western Australia Medical School
2nd floor, Harry Perkins North
6 Verdun St
Nedlands
WA
6009
Country 123624 0
Australia
Phone 123624 0
+61 0861511107
Fax 123624 0
Email 123624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
Available for what types of analyses?
For individual participant data meta-analysis
How or where can data be obtained?
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in UWA's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals may be obtained by emailing the principal investigator ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.