Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000191291
Ethics application status
Approved
Date submitted
28/11/2017
Date registered
7/02/2018
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Capability, capacity, and culture change: Building confidence and competence in nurses to prevent, recognise, and respond to clinically deteriorating patients in mental health units
Scientific title
A workplace culture program targeting confidence and competence in nurses to prevent, recognise, and respond to clinically deteriorating patients in mental health units
Secondary ID [1] 293450 0
None
Universal Trial Number (UTN)
U1111-1205-7445
Trial acronym
CUBIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinically deteriorating in-patients in mental health units 305629 0
Condition category
Condition code
Public Health 304850 304850 0 0
Health service research
Mental Health 305451 305451 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An organisational change consultant will work with nurse leaders and nurses to collectively identify the type and style of strategies that will support them in achieving key objectives. The positive workplace culture program will focus on assisting staff to develop strategic self-awareness of their leadership style, strengths, motivations, drivers, and potential weaknesses particularly in the context of leading and co-creating culture change. Two programs will run concurrently – one for the nurse leaders, which will focus on leadership capability and cultural transformation and a program run ‘at the coal face’ with Nurses.

The Positive Workplace Culture Program will be tailored to the individual sites based on findings from baseline focus groups and questionnaires. The program will be delivered by an organisational change consultant in Phase 2 (3-15 months) of the study. The program will be delivered to nurse leaders in group sessions during professional development time, and to nurses in groups during in-services.

Phases 1, 3 and 4 consist of the collection of both quantitative (surveys and audit) and qualitative (individual interviews and focus groups) data. Baseline data will be collected during Phase 1 (0-2 months). The Positive Workplace Culture Program will be implemented during Phase 2 (3-15 months) and is briefly described above. The immediate impact of the Positive Workplace Culture Program will be measured during Phase 3 (16-18 months), while the sustainability of the Positive Workplace Culture Program will be assessed during Phase 4 (19-21 months).
Intervention code [1] 299715 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304052 0
Staff knowledge relating to recognising and responding to clinically deteriorating patients in mental health units will be assessed by a questionnaire designed specifically for this study.
Timepoint [1] 304052 0
Phase 4 (19-21 months: sustainability) is the primary endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Primary outcome [2] 304249 0
Staff skills relating to recognising and responding to clinically deteriorating patients in mental health units will be assessed by a questionnaire designed specifically for this study.
Timepoint [2] 304249 0
Phase 4 (19-21 months: sustainability) is the primary endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Primary outcome [3] 304250 0
Staff attitudes relating to recognising and responding to clinically deteriorating patients in mental health units will be assessed by a questionnaire designed specifically for this study.
Timepoint [3] 304250 0
Phase 4 (19-21 months: sustainability) is the primary endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Secondary outcome [1] 340795 0
Adverse events in mental health in-patients will be assessed by examining IIMS and SAC data.
Timepoint [1] 340795 0
Phase 4 (19-21 months: sustainability) is the main endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Secondary outcome [2] 340796 0
Use of restraints on mental health in-patients will be assessed by examining IIMS and SAC data.
Timepoint [2] 340796 0
Phase 4 (19-21 months: sustainability) is the main endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Secondary outcome [3] 340797 0
Incidence of aggression in mental health in-patients will be assessed by examining IIMS and SAC data.
Timepoint [3] 340797 0
Phase 4 (19-21 months: sustainability) is the main endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Secondary outcome [4] 340798 0
Compliance with Observation Policy for Mental Health Inpatient Units will be audited using the Quality Audit Reporting System (QARS) developed by the Clinical Excellence Commission.
Timepoint [4] 340798 0
Phase 4 (19-21 months: sustainability) is the main endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Secondary outcome [5] 340799 0
Staff engagement time with mental health in-patients will be examined using a time and motion approach (in-house “Activity Follow” tool) to measure direct patient time. The frequency and content of documentation in medical records will also be examined.
Timepoint [5] 340799 0
Phase 4 (19-21 months: sustainability) is the main endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.
Secondary outcome [6] 341369 0
Use of seclusion for mental health in-patients will be assessed by examining IIMS and SAC data.
Timepoint [6] 341369 0
Phase 4 (19-21 months: sustainability) is the main endpoint.
Data will also be collected during Phase 1 (0-2 months: baseline) and Phase 3 (16-18 months: immediate impact).
Data will be collected only once during each phase.

Eligibility
Key inclusion criteria
All nursing staff (mental health nurse leaders and nurses) working in the adult in-patient mental health units at Bankstown, Campbelltown and Liverpool Hospitals will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data from questionnaires will be entered and analysed using IBM SPSS Statistics for Windows Version 24. Descriptive statistics will be used to summarise the characteristics of participants and aggregate scores, percentages, central tendency and spread of variables will be computed. Continuous data will be expressed as mean, standard deviation (SD) and range. Categorical data will be expressed as median and interquartile range (IQR), and nominal data as frequencies and percentages. Conditional on the results of tests of normality of the SAQ scores, independent t-test or the non-parametric equivalence, the Mann-Whitney U test, will be used to test for statistical significance, between SAQ score at baseline and the two follow-ups. A p value of <0.05 will be considered statistically significant.

Qualitative data from the focus groups will be coded and analysed using QSR NVivo Version 11 (QSR International Pty Ltd, Doncaster, Vic., Australia). An inductive approach to thematic analysis will be undertaken to determine latent themes within the data (Braun and Clarke 2006). Initial codes will be generated for each focus group. These initial codes will then be grouped into main themes and confirmed for both focus groups.

The data collection tool (CUBIC Questionnaire) was developed for this study, and consists of a number of validated tools including the Organisational Culture Assessment Instrument (OCAI) (Suderman, J. (2012). Using the Organizational Cultural Assessment (OCAI) as a tool for new team development. Journal of Practical Consulting, 4(1), 52-58) and the Safety Attitudes Questionnaire (SAQ) (Soh, S.-E., Barker, A., Morello, R., Dalton, M., & Brand, C. (2016). Measuring safety climate in acute hospitals: Rasch analysis of the safety attitudes questionnaire. BMC Health Services Research, 16(1), 497. doi:10.1186/s12913-016-1744-4).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/02/2018
Actual
16/05/2018
Date of last participant enrolment
Anticipated
Actual
31/10/2018
Date of last data collection
Anticipated
1/05/2019
Actual
Sample size
Target
210
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9442 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 9443 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 9444 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 18156 0
2200 - Bankstown
Recruitment postcode(s) [2] 18157 0
2560 - Campbelltown
Recruitment postcode(s) [3] 18158 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 298076 0
Government body
Name [1] 298076 0
Nursing and Midwifery Office
Country [1] 298076 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
South Western Sydney Local Health District
Locked Bag 7279
Liverpool BC NSW 1871
Country
Australia
Secondary sponsor category [1] 297153 0
Other
Name [1] 297153 0
Centre for Applied Nursing Research
Address [1] 297153 0
Centre for Applied Nursing Research
Locked Bag 7103
Liverpool BC NSW 1871
Country [1] 297153 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299098 0
SWSLHD Research and Ethics Office
Ethics committee address [1] 299098 0
Ethics committee country [1] 299098 0
Australia
Date submitted for ethics approval [1] 299098 0
29/08/2017
Approval date [1] 299098 0
11/10/2017
Ethics approval number [1] 299098 0
HREC/17/LPOOL/363, Local Project Number HE17/198

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2213 2213 0 0
/AnzctrAttachments/374055-CUBIC_Protocol_V1_20170828.pdf (Protocol)
Attachments [2] 2214 2214 0 0
/AnzctrAttachments/374055-CUBIC_Approval_NEAF_20171011.pdf (Ethics approval)
Attachments [3] 2215 2215 0 0
/AnzctrAttachments/374055-CUBIC_Approval_SSA_20171027.pdf (Ethics approval)
Attachments [4] 2216 2216 0 0
/AnzctrAttachments/374055-CUBIC_PIS_Master_Managers_V1_20170828.pdf (Participant information/consent)
Attachments [5] 2217 2217 0 0
/AnzctrAttachments/374055-CUBIC_PIS_Master_Nurses_V1_20170828.pdf (Participant information/consent)
Attachments [6] 2229 2229 0 0
/AnzctrAttachments/374055-CUBIC_FocusGroupQuestionGuide_Baseline_V1_20170828.pdf (Supplementary information)
Attachments [7] 2230 2230 0 0
/AnzctrAttachments/374055-CUBIC_FocusGroupQuestionGuide_FollowUp_V2_20170920.pdf (Supplementary information)
Attachments [8] 2757 2757 0 0
/AnzctrAttachments/374055-CUBIC_Questionnaire_V3_20180403.pdf (Other)

Contacts
Principal investigator
Name 79278 0
Dr Bronwyn Everett
Address 79278 0
Centre for Applied Nursing Research
Locked Bag 7103
Liverpool BC NSW 1871
Country 79278 0
Australia
Phone 79278 0
+61 2 8738 9360
Fax 79278 0
Email 79278 0
[email protected]
Contact person for public queries
Name 79279 0
Bronwyn Everett
Address 79279 0
Centre for Applied Nursing Research
Locked Bag 7103
Liverpool BC NSW 1871
Country 79279 0
Australia
Phone 79279 0
+61 2 8738 9360
Fax 79279 0
Email 79279 0
[email protected]
Contact person for scientific queries
Name 79280 0
Bronwyn Everett
Address 79280 0
Centre for Applied Nursing Research
Locked Bag 7103
Liverpool BC NSW 1871
Country 79280 0
Australia
Phone 79280 0
+61 2 8738 9360
Fax 79280 0
Email 79280 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
No individual data will be available.


What supporting documents are/will be available?

No Supporting Document Provided



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.