Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002007213
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
14/12/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Creating respectful workplaces for nurses in regional acute care settings
Scientific title
Utilising educational workshops (The Respectful Workplace Workshops) to improve workplace behaviour amongst registered nurses in the regional acute care setting
Secondary ID [1] 294207 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace culture 306849 0
Condition category
Condition code
Other 305944 305944 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In 2013, Hunter New England Local Health District (HNELHD) developed the Respectful workplace policy in response to recognition that many employee related grievances were related to incivility or “workplace discourtesy” (HNELHD, 2016). It is recognised that incivility or ‘workplace discourtesy’ if allowed to continue can manifest into higher levels of bullying and harassment (HNELHD, 2016). The policy and the proceeding development of Respectful Workplace Workshops for HNELHD staff, has been focusing on reinforcing expected values based behaviours in the workplace (HNELHD, 2016).

The respectful workplace workshops consisted of three modules all delivered face to face by one of two employees of the Respectful Workplace team whom have worked in the workforce devision of HNEHEALTH for at least 2 years. One member was located in the New England North West Region and the other located in the newcastle region. The workshops were delivered multiple times at 2 regional acute care hospitals over a period of 3 months to increase ability of nurse attendance.

The following is an overview of the workshops;
Module 1 – Introduction to respectful workplaces – Participants are challenged and encouraged to consider individual responsibilities and contributions to supporting a respectful workplace, including responding to unhelpful behaviour from others.
Module 2 – Straight Talk TM- Participants will learn about and practice using a conversation structure which helps them to communicate clearly, directly and respectfully in a concise manner with concrete outcomes.
Module 3 – Coaching for resolving conflict – Explores the role of the manager in supporting a respectful workplace, and supports managers in using the Assisted resolution pathway, and coaching for resolving conflict.
The workshops utilise various methods of teaching styles including educational lectures, and group work involving role play in order to achieve the learning outcomes.

All staff who met the inclusion criteria at the interventional sites were encouraged to attend Modules 1 and 2, and Module 3 was designed specifically for manager attendance only. Module 1 and 2 required staff to attend for 2 hours for each, and Module 3 also required NUMs to attend for a further 4 hours. This study design was non-randomised, and relied on staff volunteering for attendance at the workshops.

Upon completion of the workshops at the intervention sites, the Respectful Workplace team sent through the total numbers only (no names) of participant Registered Nurses/Nurse Unit Manager/New Graduate from each ward at each intervention site.

Intervention code [1] 300496 0
Behaviour
Comparator / control treatment
The control group consisted of nurses from two regional acute care hospitals who did not have the opportunity to attend the educational intervention.
Control group
Active

Outcomes
Primary outcome [1] 308118 0
Exposure to bullying and incivility as measured via the Respectful workplace behaviour questionairre.

For the purpose of this study workplace bullying was defined as behaviour which is offensive, intimidating, intended to humiliate or threatening and is directed at a staff member or a group of staff members, and occurring in the course of or related to work in NSW Health.
Workplace bullying will generally meet the following criteria:
• It is repeated and systematic (although a serious single incident can also constitute bullying)
• It is unwelcome and unsolicited
• The recipient/s consider/s the behaviour to be offensive, intimidating, intended to humiliate or threatening
• A reasonable person would consider the behaviour to be offensive, intimidating, intended to humiliate or threatening (NSW Health, 2011)

For the purpose of this study workplace incivility was defined as lower level, ‘subtle’ forms of workplace mistreatment. Examples of workplace incivility may include but are not limited to - having your ideas or opinions dismissed, having derogatory or demeaning remarks made about your work, feeling belittled or humiliated, being started at/watched/followed, being yelled at or being excluded from social activities.

Timepoint [1] 308118 0
Respectful workplace behaviour questionairre was utilised pre intervention and followed up between 2-4 months post intervention. Negative workplace behaviour was measured using the NAQ-R (Negative acts questionnaire revised), and bullying and incivility were measured via participants indicating how often they were exposed to bullying/incivility ranging from Not at all, Yes, rarely. Yes, now and then. Yes several times per week. Yes, daily.
Primary outcome [2] 308119 0
Change/modification of ways of coping as measured by the ways of coping questionnaire
Timepoint [2] 308119 0
Ways of coping measured in pre intervention and 2 - 4 months post intervention
Secondary outcome [1] 353993 0
To assess if learning outcomes from Respectful workplace workshops 1 - 2 have been met (all new graduates, nurses and NUMS).

Firstly, assess the participants awareness of policy within the health district
Timepoint [1] 353993 0
As measured in the respectful workplace questionnaire pre and post intervention.
This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.
Secondary outcome [2] 354640 0
Secondly, measure the participants self assessed ability to utilise the self resolution pathway (part of the health districts policy and procedure for management of negative workplace behaviour).




Timepoint [2] 354640 0
As measured in the respectful workplace questionnaire pre and post intervention.
This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.
Secondary outcome [3] 354901 0
Thirdly, to assess the participants self assessed ability to challenge disrespectful behaviour
Timepoint [3] 354901 0
As measured in the respectful workplace questionnaire pre and post intervention.
This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.
Secondary outcome [4] 354902 0
Lastly to assess, the participants knowledge of when to escalate to the assisted resolution pathway (part of the health districts policy and procedure for management of negative workplace behaviour).

Timepoint [4] 354902 0
As measured in the respectful workplace questionnaire pre and post intervention.
This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.
Secondary outcome [5] 354903 0
To assess if learning outcomes from workshop 3 (Nums only) have been met.

Firstly, the Nurse unit managers ability to utilise assisted resolution pathway (part of the health districts policy and procedure for management of negative workplace behaviour).


Timepoint [5] 354903 0
As measured in the respectful workplace questionnaire pre and post intervention This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.
Secondary outcome [6] 354904 0
Secondly, measure the nurse unit managers self assessed level of confidence in having difficult conversations.
Timepoint [6] 354904 0
As measured in the respectful workplace questionnaire pre and post intervention This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.
Secondary outcome [7] 354906 0
Lastly, to measure if there has been a self perceived significant change in the managers ability to manage and address bullying and incivility
Timepoint [7] 354906 0
As measured in the respectful workplace questionnaire pre and post intervention This is a study specific survey. Participants will also have the opportunity to participate in an interview (open ended questions) to discuss the workshop, and what changes if any they feel it is had upon their own and others behaviours.

Eligibility
Key inclusion criteria
The inclusion criteria for hospitals include:
1) Acute Hospital within HNELHD
2) Low percentage of previous attendance at Respectful Workplace Workshops.
3) Run or Provide a Transition to Practice Program (TPP)

The inclusion criteria for units/wards include:
1) Located in one of nominated hospitals
2) Is a medical/surgical ward.
3) Employs new graduate nurses
4) NUM is in a permanent position and will remain in position for duration of the study.

The inclusion criteria for new graduate nurses include:
1) Registered Nurse
2) Employed under 1 years
3) Employed in Transition to Practice Program (TPP).

The inclusion criteria for other registered nurses include:
1) Registered nurse
2) Working on participating unit/wards
3) Work at least 0.6 FTE
4) Will attend and complete the intervention

The inclusion criteria for NUMs include:
1) Manager of the participating unit
2) Working in permanent position
3) Will attend and complete the intervention


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for the units/wards include:
1) Those that are speciality wards (i.e. ED, NICU, Paediatrics, ICU)
2) Community health and mental health
3) Wards with Acting NUMs or wards with expected change of leadership over the study period.
The exclusion criteria for new graduate nurses include:
1) Employed over 2 years
2) Not on TPP
3) Those who will take extended leave during study period.

The exclusion criteria for other registered nurses include:
1) Work less than 0.6 FTE
2) Have attended HNELHD Respectful Workplace Workshops previously
3) Will take extended leave during study period.

The exclusion criteria for NUMs include:
1) Acting in Role
2) Have attended HNELHD Respectful Workplace Workshops previously
3) Will take extended leave during study period.

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



Intervention assignment
Other
Other design features
The hospitals for inclusion in the study were selected in consultation with the respectful workplace team by reviewing any previous attendance at the Respectful workplace workshops. In this study, some minimal potential RN participants from the selected sites may have already been exposed to the HNELHD Respectful Workplace training held at other hospitals, therefore a true experimental design and random sampling was not applicable. Two hospitals were assigned into the control group and two were assigned to the intervention group. Medical and surgical wards were selected for involvement to due to the high percentage of employment of new graduate nurses into those areas.

This is a mixed methods study with quantitative pre and post intervention survey data collection, and post intervention qualitative interviews also being undertaken.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a 30% consent rate, we anticipate there will be data from approximately 35 intervention nurses and 35 control nurses, which will give the study 80% power to detect a 0.7 SD (moderate Cohens effect size) reduction in exposure to bullying (total score of the NAQ-R) with 80% power and 5% type 1 error rate (Dr Chris Oldmeadow personal communication 7th November, 2017)

The primary data will be drawn from the total new graduate cohort from all four hospitals, registered nurses and NUMs working on the selected included wards/units. This includes new graduate participants (approximately n=64), other registered nurse participants (approximately n=152) and NUMs (n= 12). The total number of participants who will be invited to participate in the surveys and interviews is approximately 228. The expected response rate for the survey and/or interview is 30% (n=68).

The quantitative data will be analysed using the ‘Strata Corp’s Strata 14 Statistical Software’. Participant characteristics will be summarised separately for intervention and control sites. Since this is a non-randomised design we will assess differences between groups using chi-square tests for categorical variables (or Fishers exact) or t-tests for continuous variables.

Differences between intervention and control sites in exposure to bullying (as assessed by the total score of the NAQ-R) will be assessed in all nurses at each post baseline follow-up using a mixed effects linear regression model. The model will include fixed effects for treatment group (Intervention vs Control), time and the interaction between treatment and time. Random effects for the unit will also be included to model potential clustering of outcomes within a unit. A random effect for individual will model repeated measures on the same individual.

Exploratory subgroup analysis will restrict analysis to new graduate nurses and RNs separately (if numbers allow), and assess differences between intervention and control in instruments that were relevant to the different cohorts

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/03/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
228
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12415 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [2] 12416 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [3] 12417 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [4] 12418 0
The Maitland Hospital - Maitland
Recruitment postcode(s) [1] 24688 0
2340 - Tamworth
Recruitment postcode(s) [2] 24689 0
2430 - Taree
Recruitment postcode(s) [3] 24690 0
2350 - Armidale
Recruitment postcode(s) [4] 24691 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 298844 0
University
Name [1] 298844 0
The University of Newcastle
Country [1] 298844 0
Australia
Funding source category [2] 301361 0
University
Name [2] 301361 0
The University of Newcastle
Country [2] 301361 0
Australia
Primary sponsor type
University
Name
The University Of Newcastle
Address
University Drive Callaghan NSW 2258
Country
Australia
Secondary sponsor category [1] 300817 0
None
Name [1] 300817 0
Address [1] 300817 0
Country [1] 300817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299788 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299788 0
Ethics committee country [1] 299788 0
Australia
Date submitted for ethics approval [1] 299788 0
01/12/2017
Approval date [1] 299788 0
21/02/2018
Ethics approval number [1] 299788 0
Reference no: 17/12/13/4.11
Ethics committee name [2] 301933 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 301933 0
Ethics committee country [2] 301933 0
Australia
Date submitted for ethics approval [2] 301933 0
01/02/2018
Approval date [2] 301933 0
23/02/2018
Ethics approval number [2] 301933 0
H-2018-0078

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

Contacts
Principal investigator
Name 81566 0
A/Prof Sarah Jeong
Address 81566 0
The University Of Newcastle
PO Box 127
Ourimbah NSW 2258
Country 81566 0
Australia
Phone 81566 0
+61 2 43494535
Fax 81566 0
Email 81566 0
[email protected]
Contact person for public queries
Name 81567 0
Sarah Jeong
Address 81567 0
The University Of Newcastle
PO Box 127
Ourimbah NSW 2258
Country 81567 0
Australia
Phone 81567 0
+61 2 43494535
Fax 81567 0
Email 81567 0
[email protected]
Contact person for scientific queries
Name 81568 0
Sarah Jeong
Address 81568 0
The University Of Newcastle
PO Box 127
Ourimbah NSW 2258
Country 81568 0
Australia
Phone 81568 0
+61 2 43494535
Fax 81568 0
Email 81568 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
We will discuss with relevant ethics committee


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hawkins, N., Jeong, S., & Smith, T. (2020). Negati... [More Details]

Documents added automatically
No additional documents have been identified.