Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001184167
Ethics application status
Approved
Date submitted
18/07/2019
Date registered
22/08/2019
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
From Medical Students to Junior Doctors - Feasibility of a Mentor supported transition through the “Resident Ready Network”
Scientific title
From Medical Students to Junior Doctors - Feasibility of a Mentor supported transition through the “Resident Ready Network”
Secondary ID [1] 298687 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RRN - The Resident Ready Network
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 313634 0
Depression 313665 0
Anxiety 313666 0
Condition category
Condition code
Mental Health 312062 312062 0 0
Depression
Mental Health 312127 312127 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions or study conditions are 1.) active participation in the Resident Ready Network (RRN) a near-peer mentoring program, or 2.) the control group.

Both conditions will involve reading the information sheet, understanding the project, and signing an informed consent form. All participants will sign up to becoming a member on a digital mentoring platform called 'Chronus'. This will be the platform used for participant contact and data collection points; however, only the RRN group will receive approximately 12-months of active near-peer mentoring.

The near-peer mentoring program, the Resident Ready Network (RRN) has been developed in consultation with medical students, doctors and researchers in South-East Queensland. The RRN will provide students with a semi-structured support network to develop a professional relationship with a junior doctor. The RRN is embedded and supported by the Chronus digital mentor platform and linked in through University of Queensland (UQ) services and processes.

Chronus is an online mentoring platform, which provides a framework allowing users to create, implement and manage mentoring programs. This platform hosts’ hundreds of worldwide mentoring programs, and the University of Queensland, Australia, has recently invested in and endorsed Chronus to promote mentoring through UQ. UQ has formalised a contractual agreement which is in line with the Universities’ policies and procedures. The mentor program is securely locked and only accessible to approved users’, with password-protected logins. UQ has embedded its’ own specific code of conduct, and privacy and confidentially agreement within the platform, and all participants, upon signing up to Chronus, are required to abide by the terms and conditions.

Medical students and junior doctors will be invited to provide informed consent and sign up through Chronus and create individual profiles. Baseline data will also be collected through Chronus as individuals sign on to the mentoring platform.

Within Chornus, UQ medical students (to-be mentees) can peruse mentor profiles and self-select a mentor that they feel might suit their needs. For those who do not wish to self-select, a 'best fit' algorithm with be run to determine best mentor-mentee pairs.

‘The Launch’ event, will be held at The Translational Research Institute (TRI), on campus at the Princess Alexandra Hospital (PAH), and will act as a welcome session and icebreaker for the first meeting of all matched mentor/mentee pairs. The launch has been planned as an introduction and networking evening, in a safe environment, known to both junior doctors and medical students and will be delivered over a 2hr timeframe. Guest speakers will share their experiences with mentoring, to highlight possible benefits and also different approaches to mentoring. Speakers for the launch evening will include the primary investigators (to describe how the RRN will function/expectations etc), as well as specialist medical consultants as well as trainee junior doctors who have engaged in other mentoring programs (do describe their previous experiences and lessons learned). This session will all be delivered face to face at the launch event. Ideas on goal setting in mentoring to achieve targeted outcomes will also be discussed. A ‘mentor agreement/objective guide’ will be available for pairs that desire more structure and support, whereas other pairs may freely chat and get to know each other at the launch. The desired outcome is for pairs to start building rapport, and from there they can shape and plan their future mentoring interactions. All available resources to support the relationship will be emailed prior to the launch event such that users who can’t attend this session have access to the same resources as those who do attend.

The RRN is designed to be semi-structured, whereby participants will meet initially at the RRN-hosted launch, which will offer them information, guidance, and some structure; however, from there participants can decide the frequency, duration and style of their mentoring interactions. it is expected tat mentor/mentee pairs meet at least 2 times per year for 1hr each time. At the launch, participants will receive a mentor agreement, and a mentor record, which they can use to guide their ongoing contact.

The RRN is designed ultimately to encourage individuals to interact in a naturalistic and comfortable way, allowing participants to tailor their mentoring experience to best suit them, as opposed to a ‘prescribed interaction’ or scripted relationship. To further support them on their personal journey, they also have access to many resources through UQ, Queensland Health and Chronus, and they will receive quarterly prompts to stay engaged.
Through the Chronus mentoring platform, mentors and mentees have access to online resources and support; example documents available to all members include ‘Helpful mentoring tips’ and ‘10-reminders for effecting mentoring’. These are resources designed for any chronus mentoring program but this resources tab (accessed via user home-page "Help Resources") will also include the RRN specific PICF's/Research Protocol. Chronus members can also access linked services at UQ including student support consultants for any extra information on mentoring and the specifics of the RRN.

Participants can engage in an online ‘Discussion Board’, where participants can interact with each other. These are designed to be ‘peer-peer’ discussion boards, meaning there will be two separate discussion boards; a mentor only discussion board, and a mentee only discussion board. These discussion boards are designed to allow within group conversations, and participants can share their experience and ideas with others in the same group. As previously described, Chronus has an agreement with UQ and all members agree to abide by the rules and regulations, and code of conduct established by UQ, so we do not anticipate any problematic interactions through the discussion board, and thus we do not believe it requires strict monitoring.

To further encourage participant engagement, mentors and mentees will receive emailed reminders at 3, 6 and 9 month time points, which will prompt users to meet up with their mentor/mentee. These reminders are strategically scheduled for times that are discrete from foreseeable high-stress events, including study weeks, assessment weeks, student graduation and public holidays and will include encouragement to meet with their mentor/mentee, suggestions to access help resources as necessary and to remind users how far into the 12 month relationship they are. At the halfway mark, participants will receive a reminder email with a short questionnaire to assess engagement and progress.


To signify the conclusion and to ‘disengage’ from the RRN, users will be emailed a notification at the 10 and also 12-month marks to remind them of the timeframes of the program-supported relationship. These notifications will function as prompts, for example "this may be the last opportunity to meet up” with their respective mentors/mentees. It will also remind them that while this specific structured and supported relationship, through Chronus and the RRN will be terminated at 12-months, that there are other support and networking opportunities available through many avenues, including Queensland Health. This will be an opportunity for users to thank their mentoring buddies and to discuss if any ongoing communication, independent of the RRN, will be looked upon as being favourable in the future. After the 12-months they will receive a final farewell email which will also invite them to complete the post-RRN measures and invite them to a RRN “Finale” BBQ function. Both functions - the Launch and the BBQ will be held at TRI. The invitation to the Finale will be extended to all participants in the entire research project, including those that did not receive a mentor or mentee (the control group). We hope this will further strengthen links within the hospital system and allow participants to network with a wider group of colleagues.


Please see the below section for details on the control group.
Intervention code [1] 314981 0
Prevention
Intervention code [2] 314982 0
Lifestyle
Intervention code [3] 315004 0
Behaviour
Comparator / control treatment
The control group will be informed about the entire project, they will sign the informed consent form, and also sign up to the digital mentor platform Chronus (to complete the requsite research surveys). The control group however will not have an active profile online, and they will not be visible nor matched with a junior doctor. This group can continue on with life as usual, and they can access their normal supports including any UQ support and student services, however, they will not receive active RRN mentoring. All control group participants will be deactivated from chronus at the end of the 12 month intervention period (after they have completed requisite study surveys) and they will be invited to the RRN “Finale” BBQ and networking function.
Control group
Active

Outcomes
Primary outcome [1] 320690 0
As a pilot study, our primary outcome is the feasibility of the RRN. Being a novel and innovative program, one outcome will be to describe the RRN framework, matching, and experience with the RRN. Descriptive statistics associated with the RRN will be explored including number of people recruited, number of successful matches and demographics of the participants. Chronus resources, use of the the Chronus platform, and contacts made with the RRN team will also be collected to inform of overall feasibility and acceptability. Pair speicifc intricacies will be explored, for example length of mentor relationships, participant retention, number of meetings per year and the mode, and content and the style of mentoring. Participant satisfaction will be assessed through the follow-up survey embedded within Chronus and through participant focus groups, which will provide more rich and in-depth feedback.

Chronus resources, use of the the Chronus platform, and contacts made with the RRN team will also be collected to inform of overall feasibility and acceptability.
Timepoint [1] 320690 0
Assessment will be undertaken at 3 monthly intervals from the start of the RRN and more detailed review at conclusion, 12 months.
Primary outcome [2] 320691 0
Perceived Stress Scale-10 (PSS-10). The PSS-10 has been psychometrically validated and chosen as it has been widely used within the health sector, whilst also having low participant burden, being a relatively short questionnaires.

Timepoint [2] 320691 0
Time points 0 (after recruitment) and timepoint 12 months.
Primary outcome [3] 320892 0
Perceived Social Support from friends survey (PSS-Fr)
The PSS - Fr has been psychometrically validated and chosen as it has been widely used in the health care system.
Timepoint [3] 320892 0
Time points 0 (after recruitment) and timepoint 12 months.
Secondary outcome [1] 372537 0
Participant experience as assessed by semi structured focus groups
Timepoint [1] 372537 0
After the conclusion of the RRN (at approximately 12 months)
Secondary outcome [2] 373272 0
Mentoring Functions Questionnaire (MFQ-9). The MFQ-9 has been psychometrically validated and chosen as it has been widely used in the health care system.
Timepoint [2] 373272 0
At the conclusion of the RRN, time point 12 months

Eligibility
Key inclusion criteria
Recruitment
The two target participant groups will be recruited in parallel, however through different processes. The recruitment phase represents phase one.

Medical Students
All senior medical students (in their fourth and final year of medical school) from the Metro South Division of UQ were identified as potential participants. To gauge interest in the program and increase awareness of the RRN, a brief introduction to the RRN was done during the university preparation week in January, at the Translational Research Institute, PAH. In accordance with ethical approval, all fourth-year medical students will receive a follow-up email, which will describe the RRN. Students will then be able to reply with an expression of interest to participate in the RRN. Official recruitment is planned for the end of August, whereby students will receive a formal invitation with an information sheet and consent form. Participants will need to provide informed consent and create a login and sign into ‘Chronus’, the digital mentor platform through which the mentor program is organised.

Junior Doctors
All junior doctors (resident medical officers in their first, second and third postgraduate years) at the PAH (one of the Metro South teaching hospitals) were identified as potential participants. The first point of contact will be investigators scheduling a short introductory meeting, to describe the available mentoring opportunity. Through email correspondence junior doctors will also be able to inform project staff if they would be interested to participate in the RRN. Official recruitment is planned for August, whereby junior doctors will receive a formal invitation with an information sheet and consent form. Junior doctors will also be required to provide informed consent and create a login and sign into Chronus.

Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mentees : will be excluded if they are not a UQ fourth year medial student enrolled in the Metro South Division of UQ
Mentors : will be excluded if they are not a junior doctor at the PAH.

General exclusion criteria : i.) anyone unable to commit to the RNN for the 12-month duration (inclusive of holiday periods)
ii.) anyone currently committed to and participating in another formal mentoring program.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After medical students have completed the informed consent process and all baseline questionnaires, they will be randomised to one of the two groups, 1.) active participation in the RRN, or 2.) the control group. This will be done via central allocation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process will be completed online using block randomization (group size = 2)(randomizer.org), whereby an unbiased randomisation list will be generated for the medical students. Furthermore, researchers will not have seen any baseline data at the point of randomisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The people analysing the results/data (data analyst) will be blind to group allocation; however participants and organisers of the RRN will not be blind to group allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We acknowledge the difficulties in the nature of this research. This research focuses on mentoring, which is based largely on interpersonal relationships and social connection, thus all individual and mentor relationships will be different. It is inherently challenging to define ‘mentoring,’ on an individual level, let alone group level, and thus challenging to accurately measure mentoring and any outcome or change resulting from this relationship.

We acknowledge that as a pilot RCT, sample size limitations may restrict analyses and we may be left with insufficient power to explore statistically significant outcome changes. Regardless of this, we believe this is an important body of work given the identified need, a need voiced by UQ medical students themselves, and a need identified in the wider literature.

As a pilot study, our main aims are to look at feasibility, acceptability and utility of the RRN. Being a novel and innovative program, one outcome will be to describe the RRN framework, matching, and experience with the RRN. Descriptive statistics associated with the RRN will be explored including number of people recruited, number of successful matches, and demographics of the participants. Use of Chronus resources and the platform will also be explored, and contacts made with the RRN team will also be collected to inform of overall feasibility and acceptability. Pair specific details will be discussed, including length of mentor relationships, participant retention, number of meetings per year and the mode, content and the style of mentoring. Participant satisfaction will be assessed through the follow-up survey embedded within Chronus and the participant focus groups, which will provide more rich and in-depth feedback.

The three tools that were chosen to look at RRN impact were the PSS-10, PSS-Fr (Mentor) and MFQ-9. Perceived stress and perceived social support will be assessed with the graduating medical students, pre- and post- and the impact of the mentor relationship on these outcomes will be compared between the RRN and the control group. As a pilot study, this data can be used to look for trends in the data, estimate effect sizes, inform power calculations and inform future RRN implementation. Perceived social support is suggested to help people manage stress, and this questionnaire was also used pre-post, in both control and active RRN group. The MFQ-9 will explore the perceived quality of the mentor relationship, and this will be analysed alongside of PSS-10 and PPS-Fr (Mentor) scores (this will only be done in the active RRN group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2019
Actual
Date of last participant enrolment
Anticipated
10/10/2019
Actual
Date of last data collection
Anticipated
13/11/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14222 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 27210 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303238 0
University
Name [1] 303238 0
University of Queensland
Country [1] 303238 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 303307 0
None
Name [1] 303307 0
None
Address [1] 303307 0
Country [1] 303307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303783 0
The Metro South Health HREC (registration number EC00167).
Ethics committee address [1] 303783 0
Ethics committee country [1] 303783 0
Australia
Date submitted for ethics approval [1] 303783 0
Approval date [1] 303783 0
03/07/2019
Ethics approval number [1] 303783 0
HREC/2019/QMS/52087

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

Contacts
Principal investigator
Name 94790 0
Ms Jacqueline Byrne
Address 94790 0
PA-Southside Clinical Unit
Faculty of Medicine, The University of Queensland
UQ QEII Jubilee Hospital Training Centre
Level 2, QEII Jubilee Hospital
Locked Bag 2, Archerfield, QLD, 4108
Country 94790 0
Australia
Phone 94790 0
+61 434818373
Fax 94790 0
Email 94790 0
jacqui.byrne@griffith.edu.au
Contact person for public queries
Name 94791 0
Mick Devlin
Address 94791 0
PA-Southside Clinical Unit
Faculty of Medicine, The University of Queensland
UQ QEII Jubilee Hospital Training Centre
Level 2, QEII Jubilee Hospital
Locked Bag 2, Archerfield, QLD, 4108
Country 94791 0
Australia
Phone 94791 0
+61 431673669
Fax 94791 0
Email 94791 0
michael.devlin@uq.edu.au
Contact person for scientific queries
Name 94792 0
Jacqueline Byrne
Address 94792 0
PA-Southside Clinical Unit
Faculty of Medicine, The University of Queensland
UQ QEII Jubilee Hospital Training Centre
Level 2, QEII Jubilee Hospital
Locked Bag 2, Archerfield, QLD, 4108
Country 94792 0
Australia
Phone 94792 0
+61 434818373
Fax 94792 0
Email 94792 0
jacqui.byrne@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data relating to feasibility and acceptability will be made available, but individual participant details, and their stress and social support scores will not be made available for individual participants. This is due to the personal nature of the data and the expected small sample size. All data will be de-identified and presented in aggregate form only.


What supporting documents are/will be available?




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.