Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000735651
Ethics application status
Approved
Date submitted
1/07/2014
Date registered
11/07/2014
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Communication Skills Training for Healthcare Workers as a technique to reduce patient perpetrated violence: A Randomized Clinical Trial.
Scientific title
Among Healthcare workers, does Communication Skills Training or mentalization training reduce patient perpetrated violence.
Secondary ID [1] 284892 0
Nil
Universal Trial Number (UTN)
U1111-1158-6871
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient aggression 292344 0
Traumatic Stress 292345 0
Condition category
Condition code
Injuries and Accidents 292673 292673 0 0
Other injuries and accidents
Public Health 292705 292705 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Communication Skills Training.

This consists of a scripted group training called "It's All About Communication" that uses video examples of clinical situations together with a workbook and trainer's guide.

The aim is for participants to reflect on their communication style and to teach them how to analyze, reflect, and modify their communication depending on the patient or client's circumstances.

The training programme consists of four weekly, face to face group sessions, administered by a facilitator using the training materials, lasting between 50 and 75 minutes.
Intervention code [1] 289705 0
Prevention
Intervention code [2] 289738 0
Behaviour
Comparator / control treatment
Mentalization.

The control group will be offered four sessions of mentalization practice, using a an acceptance and compassion model.

The training programme consists of four weekly, face to face group sessions, administered by a facilitator using the training materials, lasting between 50 and 75 minutes.
Control group
Active

Outcomes
Primary outcome [1] 292518 0
Perception of Patient Aggression Scale, NZ modification (POPAS-NZ)
Timepoint [1] 292518 0
Baseline, post intervention (at week four), one month later (week eight, three and six months later
Secondary outcome [1] 309132 0
Impact of Events Scale, Revised, Patient completed.
Timepoint [1] 309132 0
Baseline, post intervention (at week four), one month later (week eight, three and six months later
Secondary outcome [2] 309133 0
Interpersonal communication competence scale (ICCS)
Timepoint [2] 309133 0
Baseline, post intervention (at week four), one month later (week eight, three and six months later
Secondary outcome [3] 309134 0
Kessler 10, Patient completed
Timepoint [3] 309134 0
Baseline, post intervention (at week four), one month later (week eight, three and six months later

Eligibility
Key inclusion criteria
Working in a healthcare or disability setting.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Caring for a member of one's personal family.
2. Unable to speak English.
3. Not a Registered Health Care Professional

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)
Within two regions of New Zealand, all healthcare providers will be contacted and permission requested to recruit from the organization.

Once this is obtained, potential participants will be met in their workplace and invited to participate. They will be given a consent form and information sheet, and time to consider and consult with family or others as to if they will participate.

Once groups of seven to nine participants in each workplace are indentified, the group will be assigned to an intervention randomly.

We cannot conceal the intervention from the group, and all outcomes are self-reported.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use computer generated random numbers held by a person outside the study, at a central site, to allocate intervention
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster (or group) randomisation, from multiple organizations.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to provide 80% power to detect differences of 0.5 SD between arms of the study at follow-up (i.e., moderate effect sizes) for the primary continuous outcomes, using two-sided tests at the 0.05 level and assuming a correlation between baseline and follow-up values of r=0.5 or higher, we would need the equivalent of 48 participants in each arm with full data. As this would involve participants nested within groups (mean of 8.5 participants/group) and nested within organisations (mean of 20 participants/organisation), assuming ICCs of 0.05 and 0.01 for these respectively, producing design effects of 1.375 and 1.19, this resulted in a final sample size of 79/group. To allow for approximately 20% loss to follow-up, 100 participants will be recruited to each arm of the study (total n=200).
Appropriate summary statistics will be presented for all outcomes of interest. Differences in changes between the two arms of the study will be examined using appropriate regression models (linear for continuous, binary logistic for dichotomised, and Poisson or negative binomial for count outcomes) adjusting for baseline values. Standard regression diagnostics will be used in each case. As missing data will potentially be informative, differences between participants with and without follow-up data will be conducted along with sensitivity analyses to examine the robustness of any findings. All statistical tests will be conducted at the two-sided 0.05 level. Stata 13.1 and R 3.1.0 (or later versions) will be used for all analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2014
Actual
9/02/2015
Date of last participant enrolment
Anticipated
Actual
8/02/2016
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
200
Accrual to date
Final
134
Recruitment outside Australia
Country [1] 6183 0
New Zealand
State/province [1] 6183 0
Otago, Auckland

Funding & Sponsors
Funding source category [1] 289515 0
Charities/Societies/Foundations
Name [1] 289515 0
Hume Memorail Fund
Country [1] 289515 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
P O Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 288202 0
Individual
Name [1] 288202 0
Christopher Gale
Address [1] 288202 0
Department of Psychological Medicine
University of Otago
P O Box 913
Dunedin 9054
Country [1] 288202 0
New Zealand
Other collaborator category [1] 279607 0
Individual
Name [1] 279607 0
Nicola Swain
Address [1] 279607 0
Department of Psychological Medicine University of Otago P O Box 913 Dunedin 9054
Country [1] 279607 0
New Zealand
Other collaborator category [2] 279608 0
Individual
Name [2] 279608 0
Maria Baby
Address [2] 279608 0
Department of Psychological Medicine University of Otago P O Box 913 Dunedin 9054
Country [2] 279608 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291260 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 291260 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 291260 0
New Zealand
Date submitted for ethics approval [1] 291260 0
19/08/2014
Approval date [1] 291260 0
02/12/2014
Ethics approval number [1] 291260 0

Summary
Brief summary
Patient initiated violence is a workplace hazard in all healthcare settings, for trained and untrained staff. A previous pilot study showed that training in communication skills decreased the rate of such aggression. In this group-randomized trial we will compare communication skills training with mindfulness, to see which decreases the risk of patient violence over six months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49570 0
Dr Christopher Gale
Address 49570 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
P O Box 913
Dunedin 9054
Country 49570 0
New Zealand
Phone 49570 0
+64 3 4797355
Fax 49570 0
+64 3 474 7934
Email 49570 0
[email protected]
Contact person for public queries
Name 49571 0
Nicola Swain
Address 49571 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
P O Box 913
Dunedin 9054
Country 49571 0
New Zealand
Phone 49571 0
+64 3 474 7299
Fax 49571 0
+64 3 474 7934
Email 49571 0
[email protected]
Contact person for scientific queries
Name 49572 0
Christopher Gale
Address 49572 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
P O Box 913
Dunedin 9054
Country 49572 0
New Zealand
Phone 49572 0
+ 64 3 474 7355
Fax 49572 0
+64 3 474 7934
Email 49572 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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