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Trial registered on ANZCTR

Registration number

ACTRN12621000382875

Ethics application status

Approved

Date submitted

11/11/2020

Date registered

6/04/2021

Date last updated

6/04/2021

Date data sharing statement initially provided

6/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of an aggression management module on student knowledge, skills and confidence: A randomised controlled trial.

Scientific title

Effect of an aggression management module on student knowledge, skills and confidence: A randomised controlled trial.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Aggression management

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Before we finalise the modules, we will have up to four small group focus groups from a few disciplines to discuss the modules and make any changes before we start the RCT. These focus groups will be held by the researchers in person if possible otherwise online and there will be questions to the facilitate discussion. These focus groups will be 60-90 minutes duration and will occur up to a year before the RCT commences.

The RCT intervention is a set of three aggression management modules that has been constructed using Articulate RISE. The modules are approximately 30 minutes duration each.

Summary of the content of the online modules:
- recognising and preventing aggression including definition of aggression and violence
- communication tips using the pneumonic S.O.L.V.E.R.
- role of the student
- responding to aggression the basics eg: code grey, code blue, code black
- aggression in healthcare - case study scenario

These modules include a number of video clips of students being confronted by aggressive clients and shows what to do in these situations.

Mode of training:
- Quizzes
- Interactive activities
- Short videos / case studies

Intervention will be delivered once and involves three modules of duration 30 minutes approximately over a period of a week.

Intervention occurs online from any location.
If able to, the 90 minute discussion will be on campus but if not able to we will conduct this online. The 90 minutes discussion will occur after the module in the intervention group and before the module in the active control group.

Strategies used to assess adherence:
- we are able to obtain statistics from our Learning Management System (LMS) Moodle.

Intervention code [1]

Behaviour

Comparator / control treatment

There will be an active control that consists of a facilitated discussion about aggression. This may involve reading a media article/ watching some media footage/ reading the aggression statistics.

The participants will attend a 90 minute discussion on their experiences of aggression. It will be moderated by the researchers. It will be face to face on campus if able to otherwise it will occur online. This will occur after the module for the intervention group and before the module for the active control group.

We will keep attendance records.

Control group

Active

Outcomes

Primary outcome [1]

The Confidence in Coping with Patient Aggression Instrument (self-rating tool conducted by students)

This measures how confident students feel to work with aggressive clients.
An example item is: "How comfortable are you in working with an aggressive
patient?". Has an 11-point Likert scale from 1 very uncomfortable to 11 very comfortable

Timepoint [1]

Pre and immediately post intervention

Secondary outcome [1]

If we are able to do a simulation we can use the De-Escalating Aggressive Behaviour Scale (English version)

The EMDABS has seven items with associated best practice descriptions that may be used to inform de-escalation practice. The EMDABS can be used in evaluating training and education program and informs how these program and individual de-escalation practice may be improved.

The seven EMDABS item are:

Valuing the client
Reducing fear
Enquiring about client's issues and anxieties
Providing guidance to the client
Working out possible agreements
Remaining calm
Risky

The health professional marking the simulation can use this outcome measure to evaluate the student.

Timepoint [1]

Immediately post intervention

Secondary outcome [2]

If we are able to do a simulation the simulated patient can complete the Consultation and Relational Empathy measure.

This measures the level of empathy students demonstrate in the interaction with simulated clients / patients.

The items are:

How was the health professional at….

Making you feel at ease

Letting you tell your story

Really listening

Being interested in you as a whole person

Fully understanding your concerns

Showing care and compassion

Being positive

Explaining things clearly

Helping you to take control

Making a plan of action with you

Timepoint [2]

Immediately post intervention

Eligibility

Key inclusion criteria

Health professional students enrolled in the following courses:
- Bachelor of Physiotherapy
- Bachelor of Occupational Therapy
- Master of Social Work
- Bachelor of Radiation Sciences
- Bachelor of Paramedicine
- Bachelor of Radiography and Medical Imaging

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Students that have already had clinical experience as part of a university degree will be excluded from the RCT but can be included in the small focus groups that will be part of helping to improve the education module.

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)

Research assistant will use the random number generator in Microsoft Excel to allocate students to groups.

The database is independent and not accessible to study personnel except for the research assistant receiving an allocated intervention assignment for a specific student.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Microsoft Excel will be used to generate the random sequence.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Data will be collated and assessed for normality and skewness.
Data will be reported using frequency, mean (standard deviation), and medians (interquartile range) where appropriate.
The difference in the results of the pre and post outcome measures will be analysed using parametric or non-parametric statistics as appropriate.
Analysis will be performed using an intention to treat approach. Further sub group analysis will be included adjusting for gender, year level and current allied health course enrolment.
Items that are identified significant in univariate testing will be entered into a multivariate ordinal logistic regression model.
The strength of association will be reported using odds ratios (OR) and 95% confidence intervals (CIs).
All tests will be two-tailed unless otherwise stated, and results will be considered statistically significant if the p-value was < 0.05.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/05/2021

Actual

Date of last participant enrolment

Anticipated

27/09/2021

Actual

Date of last data collection

Anticipated

1/12/2021

Actual

Sample size

Target

276

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Building B
McMahons Road
Frankston Victoria Australia 3199

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Building B
McMahon's Road
Frankston Victoria Australia 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University 
Wellington Road Clayton
Victoria
Australia
3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/09/2020

Approval date [1]

12/10/2020

Ethics approval number [1]

23695

Summary

Brief summary

Following a systematic review and research led by the chief investigator Dr. Kristin Lo, we have found that:

1. Aggression is common in the healthcare setting. The 2011 Victorian Government Parliamentary Inquiry into violence and security arrangements in Victorian hospitals reported 2,662 potential or aggressive events occurring across four major regional hospitals over a 6-month period.
2. Aggression happens to students. An Australian study identified nearly 60% of second and third year (87 total) nursing students had experienced non-physical aggression and violence in the clinical setting. Physical aggression amounted to over a third of the second year students and one quarter of third year students (51 total).
3. Students are more likely to be on the receiving end of acts of aggression as inexperienced.
4. Student do not feel confident managing clients who are aggressive.
5. Consequences of aggression include: increased student attrition, long term physical and psychological damage to the student population.
6. There are a lack of high quality trials, such as randomised controlled trials, investigating the effects of specific education on management of aggression. 
7. Education delivered in studies reporting increased student confidence include lower duration combined with a mixture of online and face to face delivery of the content. Short simulations are also found to be sufficient to improve knowledge in managing aggression.

So, we know that aggression in clinical placements is common for health professional students, students are needing support, and there are suggestions regarding education delivery for improving students' management of aggression.

We believe the significance of providing students with basic aggression management education before attending placements will result in:
1. Increased student confidence in identifying and managing aggression.
2. Reducing the negative physical and psychological effects of aggression.
3. Improved client management

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kristin Lo / Katrina Recoche

Address

School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
PO Box 527, Frankston, VIC, 3199, Australia

Country

Australia

Phone

+61 399044509

Fax

[email protected]

Contact person for public queries

Name

Steven Lau

Address

Department of Physiotherapy
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
PO Box 527, Frankston, VIC, 3199, Australia

Country

Australia

Phone

+61 425022006

Fax

[email protected]

Contact person for scientific queries

Name

Steven Lau

Address

Department of Physiotherapy
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
PO Box 527, Frankston, VIC, 3199, Australia

Country

Australia

Phone

+61 425022006

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

This was not included in our ethics approval.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9463	Study protocol				We intend to publish the study protocol in a journ... [More Details]

Results publications and other study-related documents

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