Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000044527
Ethics application status
Approved
Date submitted
1/11/2023
Date registered
18/01/2024
Date last updated
18/01/2024
Date data sharing statement initially provided
18/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of Safewards to manage the use of restrictive practices in residential aged care
Scientific title
Evaluating the effectiveness and feasibility of Safewards in managing restrictive practices for people with dementia and other complex needs in residential aged care.
Secondary ID [1] 310147 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 332425 0
Responsive behaviours 332426 0
Condition category
Condition code
Neurological 327586 327586 0 0
Dementias
Public Health 329115 329115 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aged care staff from a range of disciplinary backgrounds will be trained in the Safewards interventions. Safewards interventions include: clear mutual expectations, soft words, positive words, talk down, bad news mitigation, knowing each other, calm down methods, reassurance, discharge messages, mutual help meetings. The clinical educator from the aged care organisation and two trainers from the project team (one staff with lived experience and one mental health clinician) will provide on-site training of aged care staff. Training will be conducted face to face or via Teams and will consist of 12 minute sessions. Staff will be invited to attend training sessions for each intervention. Implementation of each intervention will occur concurrently with training over 12 weeks. We are aiming to train 50% of staff from each site in each intervention. Attendance will be monitored via a records sheet. An on-line community of practice group between sites will be established to share learnings and support implementation across sites.

Posters about Safewards will inform residents and families of the project. Letters will be sent to families informing them of Safewards. Families and residents will be invited to participate in relevant interventions e.g., know each other, meaningful messages.
Intervention code [1] 326563 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335420 0
Any change in use of restrictive measures in residential aged care determined by review of incident reports, medication charts.
Timepoint [1] 335420 0
3 months after commencement of interventions
Secondary outcome [1] 424467 0
Reach- the number of staff who are willing to participate in the intervention as measured by the training attendance records.
Timepoint [1] 424467 0
At completion of the implementation phase
Secondary outcome [2] 430226 0
Adoption- the number, proportion and representativeness on staff and settings who delivered the intervention as measured by Setting exclusions/inclusions (% units and reasons); Staff exclusions/inclusions (% of staff invited that participate in training); degree of implementation of Safewards (number of interventions implemented) and focus groups (or interviews) to understand staff perceptions of barriers and enablers to setting- and staff-level adoption.
Timepoint [2] 430226 0
At completion of Safewards implementation.
Secondary outcome [3] 430227 0
Implementation and maintenance- to determine the fidelity of delivery of the intervention. post implementation surveys to evaluate staff perceptions of uptake (feasibility and suitability) and adaptations made to the intervention for the setting; Safewards Fidelity Checklist to assess adherence to the Safewards program
Timepoint [3] 430227 0
Fidelity Checklist to be conducted 3 months and 6 months after commencement of Safewards. Post implementation survey to be conducted at completion of implementation phase.
Secondary outcome [4] 430228 0
Identification of the key contextual factors that supported successful implementation as informed by interviews and focus roups with aged care staff and leaders of the organization based on the Consolidated Framework for Implementation Research (CFIR) domains.
Timepoint [4] 430228 0
At completion of the implementation phase.
Secondary outcome [5] 430784 0
Reach- the proportion of staff who are willing to participate in the intervention as measured by the training attendance records.
Timepoint [5] 430784 0
At completion of the implementation phase
Secondary outcome [6] 430785 0
Reach- the characteristics of staff who are willing to participate in the intervention as measured by the training attendance records. As obtained from training attendance records.
Timepoint [6] 430785 0
At completion of the implementation phase

Eligibility
Key inclusion criteria
Aged care staff (n= 200) who work in the homes participating in the study and the organisational leaders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participation is voluntary and there are no exclusion criteria.

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/10/2023
Date of last participant enrolment
Anticipated
2/02/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
200
Accrual to date
51
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314308 0
Commercial sector/Industry
Name [1] 314308 0
Aged Care Research & Industry Innovation Australia (ARIIA)
Country [1] 314308 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Uniting Communities Incorporated
Address
43 Franklin Street, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 316256 0
University
Name [1] 316256 0
Flinders University
Address [1] 316256 0
Sturt Road, Bedford Park SA 5042
Country [1] 316256 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313419 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313419 0
Ethics committee country [1] 313419 0
Australia
Date submitted for ethics approval [1] 313419 0
22/05/2023
Approval date [1] 313419 0
16/10/2023
Ethics approval number [1] 313419 0
6173

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

Contacts
Principal investigator
Name 128094 0
Dr Suzanne Dawson
Address 128094 0
Flinders University, GPO Box 2100, Adelaide SA 5001
Country 128094 0
Australia
Phone 128094 0
+61 0435 716 477
Fax 128094 0
Email 128094 0
[email protected]
Contact person for public queries
Name 128095 0
Suzanne Dawson
Address 128095 0
Flinders University, GPO Box 2100, Adelaide SA 5001
Country 128095 0
Australia
Phone 128095 0
+61 0435 716 477
Fax 128095 0
Email 128095 0
[email protected]
Contact person for scientific queries
Name 128096 0
Suzanne Dawson
Address 128096 0
Flinders University, GPO Box 2100, Adelaide SA 5001
Country 128096 0
Australia
Phone 128096 0
+61 0435 716 477
Fax 128096 0
Email 128096 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


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.