Trial Review

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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] 302508 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aggression management 319414 0
Condition category
Condition code
Public Health 317388 317388 0 0
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] 318832 0
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] 325425 0
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] 325425 0
Pre and immediately post intervention
Secondary outcome [1] 387907 0
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] 387907 0
Immediately post intervention
Secondary outcome [2] 392116 0
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] 392116 0
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] 306940 0
University
Name [1] 306940 0
Monash University
Country [1] 306940 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Building B
McMahon's Road
Frankston Victoria Australia 3199
Country
Australia
Secondary sponsor category [1] 307500 0
None
Name [1] 307500 0
Address [1] 307500 0
Country [1] 307500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307084 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 307084 0
Ethics committee country [1] 307084 0
Australia
Date submitted for ethics approval [1] 307084 0
14/09/2020
Approval date [1] 307084 0
12/10/2020
Ethics approval number [1] 307084 0
23695

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

Contacts
Principal investigator
Name 105974 0
Dr Kristin Lo / Katrina Recoche
Address 105974 0
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
PO Box 527, Frankston, VIC, 3199, Australia
Country 105974 0
Australia
Phone 105974 0
+61 399044509
Fax 105974 0
Email 105974 0
[email protected]
Contact person for public queries
Name 105975 0
Steven Lau
Address 105975 0
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 105975 0
Australia
Phone 105975 0
+61 425022006
Fax 105975 0
Email 105975 0
[email protected]
Contact person for scientific queries
Name 105976 0
Steven Lau
Address 105976 0
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 105976 0
Australia
Phone 105976 0
+61 425022006
Fax 105976 0
Email 105976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not included in our ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9463Study protocol    We intend to publish the study protocol in a journ... [More Details]



Results publications and other study-related documents

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