Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001070921
Ethics application status
Approved
Date submitted
14/10/2011
Date registered
14/10/2011
Date last updated
26/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising the residential and community aged care workforce: The evidence-based development of clinical leadership in middle managers in aged care
Scientific title
The effect of the Clinical Leadership in Aged Care (CLiAC) program for residential and community aged care middle managers on the care work environment, care quality, staff turnover, stress/burnout, job satisfaction, and cost benefit, compared with a no program control group (NP)
Secondary ID [1] 273199 0
Nil
Universal Trial Number (UTN)
U1111-1123-2305
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical leadership in aged care 278955 0
Condition category
Condition code
Other 279134 279134 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
CLiAC has been developed based on the aged care-specific clinical leadership qualities framework (ACLQF) and informed by key principles of the content and evaluation of the Clinical Excellence Commission Clinical Leadership (CEC-CL) program. CLiAC aims to achieve safe, high-quality person-centred and evidence-based care by assisting care managers to develop effective team relationships and consumer/client-centred leadership strategies that enable them to deal with the day-to-day realities of care service.
CLiAC will be a structured program and delivered to middle managers from 6 residential aged care facilities and 6 community aged care services (intervention group) over 12 months by a program facilitator who will be mentored by an expert facilitator.
The core topics will be covered in 4 modules via 10 full day workshops, combined with action learning, case scenarios, one-on-one interactions with a program facilitator, and individual practice improvement projects and process evaluation including 360-degree review.
Intervention code [1] 269531 0
Behaviour
Comparator / control treatment
A no program control (NP) group will receive no special intervention or education. The NP group will continue usual care and practice for the duration of the study.
Control group
Active

Outcomes
Primary outcome [1] 279779 0
Work environment for aged care staff as assessed using a Work Environment Scale-R subscales and Multi-factor Leadership Questionnaire (MLQ)-S (for staff)
Timepoint [1] 279779 0
at 1.5 years after intervention commencement
Primary outcome [2] 279780 0
Care quality and safety for aged care recipients as assessed using clinical indicators (unplanned hospital admission, fall with injury, unintentional weight loss >2kgs, new pressure areas, new urinary tract infection) and a Person-centred Care Assessment Tool (P-CAT)
Timepoint [2] 279780 0
at baseline, and at 9 months and 18 months after intervention commencement
Primary outcome [3] 279781 0
Staff turnover rates
Timepoint [3] 279781 0
at baseline, and at 9 months and 18 months after intervention commencement
Secondary outcome [1] 294411 0
Cost benefits in terms of cost of retaining and recruiting aged care staff, as well as cost of care to aged care service providers
Timepoint [1] 294411 0
at baseline, and at 9 months and 18 months after intervention commencement
Secondary outcome [2] 294412 0
aged care managers' knowledge and skills in leadership and management as assessed using a modified NHS Leadership Centre Evaluation Questionnaire, Multi-factor Leadership Questionnaire (MLQ)-M (for managers) and Approaches to Dementia Questionnaire
Timepoint [2] 294412 0
at 9 months and 18 months after intervention commencement
Secondary outcome [3] 294414 0
aged care staff intention to stay and intention to leave as assessed using Workforce Dynamics Questionnaire
Timepoint [3] 294414 0
at baseline, and at 9 months and 18 months after intervention commencement
Secondary outcome [4] 294415 0
stress levels in aged care staff as assessed using Workforce Dynamics Questionnaire
Timepoint [4] 294415 0
at baseline, and at 9 months and 18 months after intervention commencement
Secondary outcome [5] 294416 0
job satisfaction for aged care staff as assessed using Workforce Dynamics Questionnaire
Timepoint [5] 294416 0
at baseline, and at 9 months and 18 months after intervention commencement

Eligibility
Key inclusion criteria
Site Inclusion Criteria:
Receive principal support for the study from the Executive Care Manager (ECM) or Community Care Manager (CCM).
ECMs or CCMs agreement that middle manager from their facility will not receive the intervention (CLiAC) during the study if they are randomly allocated to the non-intervention group.
Middle Manager/Care Staff Inclusion Criteria:
Currently work in a middle management or in a direct care role for the participating aged care organisation.
Have been employed by the participating organisation for a minimum of six months.
For community aged care services staff be involved in the delivery of extended aged care at home (EACH), EACH-D (dementia), and community aged care packages (CACP).
Consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sites which are currently (or in the near future) undergoing major management/structural changes.
Middle Manager/Care Staff Exclusion Criteria:
Staff involved in non direct care roles (e.g. administration, maintenance)

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)
Allocation involved contacting the holder of the allocation schedule who was at central administration site.

The lead CI (JEON) was invited to explain the study and its processes to senior managers of residential and community aged care services at one of the participating aged care organisation quarterly meetings. The senior managers had the opportunity to ask questions and clarify any issues at the meetings, and then pass this information to their staff and middle managers.

Initial site selection (site as unit of randomisation): according to the site eligibility criteria described earlier, the research team was advised of all potential eligible sites for the study by the participating aged care organisation central executive management.

Recruitment of managers to participate in the Clinical Leadership in Aged Care (CLiAC) program: 1) An invitation letter was sent to all senior and middle managers of eligible sites. All potential participants agreed to inclusion on the basis that they may not receive the intervention during the study, but if they were randomly allocated to the non-intervention group, they would have the option of being offered the intervention once the project is completed. 2) All sites that met the eligibility criteria were approached and invited to participate in random order until 12 Residential Aged Care Facilities and 12 Community Aged Care Services had agreed to participate. For this, sites were stratified by type (RACF or CACS) and randomly permuted within each stratum using software available at www.randomization.com. 3) Once the researchers had established the research sites (where middle managers had agreed to participate in the clinical leadership program), restricted randomisation was used to balance the groups. The intervention is being conducted as part of the participating organisation’s leadership development initiative, but the CIs and senior executives of the participating organisation have agreed that there will be no coercion imposed on the managers and the managers will need to volunteer to participate in the intervention and subsequent data collections.

Recruitment of Managers in the Survey: All managers from both intervention and non-intervention sites will be invited to participate in the survey. Return of their questionnaire will be considered as consent (implied consent).
Recruitment of care staff in the Survey: An invitation letter and a set of questionnaires will be sent to all eligible staff of the participating sites from the research team. Return of their questionnaire will be considered as consent (implied consent). The participants will be asked to return their completed questionnaire in the stamped return addressed envelope provided with the documentation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites were stratified by type of aged care (residential vs. community aged care). Within each stratum, restricted randomisation was used to balance the groups by: size of the service (number of clients), span of control (staff and management ratio) and geographical location (rural vs. urban). This was done using a program in Gauss supplied by Professor Larry Moulton of Johns Hopkins University, co-author of the textbook ‘Cluster Randomised Trials’.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised trial, randomised by site.

Apart from the managers receiving the clinical leadership program intervention (CLiAC), participating staff from all residential and community care sites will be blind to intervention allocation, however, due to the nature of the intervention maintaining blindness may not be feasible. To maximise blindness participating managers will be asked not to discuss their training with their work teams.
Research team members assessing the outcomes (assessor) and analysing the results/data (data analyst) will be blind to allocation of the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
31/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270024 0
Government body
Name [1] 270024 0
Australian Research Council
Country [1] 270024 0
Australia
Funding source category [2] 270025 0
Other
Name [2] 270025 0
Baptist Community Services NSW & ACT
Country [2] 270025 0
Australia
Primary sponsor type
Individual
Name
Yun-Hee Jeon
Address
Sydney Nursing School, Rm A5.13, Lv 5 M02, 88 Mallett Street, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 269000 0
Other
Name [1] 269000 0
Baptist Community Services NSW & ACT
Address [1] 269000 0
PO Box 655, Epping, NSW, 2121
Country [1] 269000 0
Australia
Other collaborator category [1] 252293 0
Individual
Name [1] 252293 0
Hal Kendig
Address [1] 252293 0
The University of Sydney, CERA Building 18 Concord Hospital, Concord, NSW 2139.
Country [1] 252293 0
Australia
Other collaborator category [2] 252294 0
Individual
Name [2] 252294 0
Judy Simpson
Address [2] 252294 0
The University of Sydney, A27 Edward Ford Building, NSW, 2006
Country [2] 252294 0
Australia
Other collaborator category [3] 252295 0
Individual
Name [3] 252295 0
Lynn Chenoweth
Address [3] 252295 0
University of Technology Sydney, Faculty of Nursing, Midwifery and Health, PO Box 123, Broadway, NSW, 2007
Country [3] 252295 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271980 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 271980 0
Ethics committee country [1] 271980 0
Date submitted for ethics approval [1] 271980 0
Approval date [1] 271980 0
25/01/2011
Ethics approval number [1] 271980 0
Database No. 13405
Ethics committee name [2] 271981 0
Baptist Community Services (BCS) Ethics Committee
Ethics committee address [2] 271981 0
Ethics committee country [2] 271981 0
Date submitted for ethics approval [2] 271981 0
Approval date [2] 271981 0
04/01/2011
Ethics approval number [2] 271981 0
EC00432

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

Contacts
Principal investigator
Name 33262 0
A/Prof Yun-Hee Jeon
Address 33262 0
Sydney Nursing School, The University of Sydney, 88 Mallett Street, Camperdown, NSW, Australia 2050
Country 33262 0
Australia
Phone 33262 0
+61 2 93510674
Fax 33262 0
Email 33262 0
[email protected]
Contact person for public queries
Name 16509 0
Yun-Hee Jeon
Address 16509 0
Sydney Nursing School, Rm A5.13, Lv 5 M02, 88 Mallett Street, Camperdown, NSW, Australia 2050
Country 16509 0
Australia
Phone 16509 0
61, 2, 9351 0674
Fax 16509 0
Email 16509 0
[email protected]
Contact person for scientific queries
Name 7437 0
Yun-Hee Jeon
Address 7437 0
Sydney Nursing School, Rm A5.13, Lv 5 M02, 88 Mallett Street, Camperdown, NSW, Australia 2050
Country 7437 0
Australia
Phone 7437 0
61, 2, 9351 0674
Fax 7437 0
Email 7437 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCluster Randomized Controlled Trial of An Aged Care Specific Leadership and Management Program to Improve Work Environment, Staff Turnover, and Care Quality.2015https://dx.doi.org/10.1016/j.jamda.2015.04.005
N.B. These documents automatically identified may not have been verified by the study sponsor.