Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001508864
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
4/11/2021
Date last updated
8/11/2022
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect on residents of a co-designed intervention on Residential Aged Care outdoor access
Scientific title
The effect of a co-designed intervention on safe access to outdoor spaces for people living in Residential Aged Care
Secondary ID [1] 305356 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lack of outdoor access 323689 0
Condition category
Condition code
Public Health 321222 321222 0 0
Health service research
Physical Medicine / Rehabilitation 321460 321460 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve an action research cycle (Defining the problem -> Action planning -> Taking action -> Analysis and evaluation -> Specifying learning and reflection) conducted in a residential aged care facility (RACF). Three facilities will implement the intervention. They include a mix of facility types and sizes in rural and metropolitan Victoria. Over a 4 month period, the intervention will be developed and implemented using an Action Plan Template and guidelines. This will include the following steps:
Step 1 (month 1): Baseline data (environmental audit, resident, family and staff surveys, policy review, routinely collected data on outdoor activities) will inform our understanding of the barriers to residents accessing outdoor spaces at each RACF. This data will be presented at a facility wide co-design workshop (1-2hours) where staff, residents, family and visitors will be invited to attend. An external research team member will present the baseline data. Possible priorities to address and strategies for safely improving outdoor access and activity will be discussed.
Step 2 (month 2): After this initial workshop, a smaller working group will be established with interested staff, residents and their family/carers who will undertake the action research cycle at their facility. The working group will be supported by the external research team who will provide any information regarding research evidence to support the process and inform decisions and the action plan.
Step 3 (month 2): The working group will determine up to four goals to overcome barriers to safe access to outdoor spaces at their facility. While small environmental modifications could be required to facilitate this process, we envisage that the strategies developed will focus on staff policies and practices and the development of activities that promote outdoor use. Large physical design modifications are out of the scope of this project but suggestions can be provided to facilities as part of the feedback process.
Step 4 (month 2): The working group will develop an action plan using an Action Plan Template and guidelines developed for this project but based on previous work using action research (Haralambous B, et al. 2010: A protocol for an individualised, facilitated and sustainable approach to implementing current evidence in preventing falls in residential aged care facilities. BMC Geriatrics, 17; 10). This includes naming the person responsible to complete each action, setting a timeline, identifying and obtaining resources needed and planning for possible obstacles to change.
Step 5 (months 3-4): The working group supported by the research team will implement, monitor and evaluate the roll-out of the action plan. The process for evaluating the action plan will be developed and incorporated into the action plan. For example, if the action plan aims to increase the number of outdoor morning teas arranged by the activities co-ordinator, then we will use existing data to audit how frequently they were previously run and the target number per week or fortnight that they intend to run them in the future. This will be monitored through the implementation and if the targets are not reached we will examine barriers to this and how we could overcome these barriers.
This is a pragmatic study that will be implemented and tailored taking account of local contexts and resources. The scale of the intervention as well as duration, frequency and number of meetings will vary according to these contexts. Each facility will receive funding to cover staff and equipment costs for implementing the study. Meetings will be held in person in each RACF. External researchers who will support the process will either attend in person or online depending on health and safety restrictions during the global pandemic. If there are no restrictions they will aim to have a mix of face to face and video-conferencing meetings. We will assess implementation of the intervention through recording number of meetings and attendance, completion of an action plan and extent to which action plan was implemented.
Intervention code [1] 321531 0
Lifestyle
Intervention code [2] 321952 0
Treatment: Other
Comparator / control treatment
3 months of seasonally matched routine data pre intervention will be used as a comparison. These data will be sourced from the participating aged care facilities from the matched seasonal periods throughout 2019-2020
Control group
Historical

Outcomes
Primary outcome [1] 328712 0
Staff perceptions of intervention goal attainment assessed by a facility wide staff survey using the 5-item goal achievement responses reported in: Turner-Stokes L, Williams H. Goal attainment scaling: a direct comparison of alternative rating methods. Clinical rehabilitation. 2010;24(1):66-73.
Timepoint [1] 328712 0
The survey will be distributed immediately after the intervention and will be collected for a one month period.
Secondary outcome [1] 400066 0
Number of outdoor activities organised by activities coordinators/lifestyle staff as recorded in routine lifestyle staff calendars.
Timepoint [1] 400066 0
Three month period seasonally controlled, pre and post intervention period.
Secondary outcome [2] 400068 0
Staff perceptions of use of outdoor spaces assessed by a facility wide staff survey adapted from the one page staff survey included in the Dementia Therapeutic Garden Audit Tool developed by Dementia Australia (www.enablingenvionrments.com.au). This tool was adapted from the Alzheimer’s Garden Audit Tool (AGAT): Cooper Marcus, Clare. 2007. "Alzheimer's Garden Audit Tool." Journal of Housing for the Elderley 21 (1-2): 179-191.
Timepoint [2] 400068 0
The survey will be distributed immediately pre and post the intervention and will be collected over a one month period.
Secondary outcome [3] 400069 0
Facility policies encourage and support safe use of outdoor spaces (assessed with a policy review)
Timepoint [3] 400069 0
Immediately pre and post intervention
Secondary outcome [4] 400070 0
Resident perceptions of changes in practices to improve access to RACF outdoor spaces. This will be collected through 1 hour focus groups and/or 15-30 minute interviews with up to a total of 10 residents at each facility. All residents at participating facilities will be invited to participate and the first 10 eligible and consenting residents will take part. The questions have been designed specifically for this study.
Timepoint [4] 400070 0
Interviews and focus groups will occur in the six weeks immediately post intervention.
Secondary outcome [5] 400072 0
Number of referrals to internal or external mental health services in the facility. A study-specific survey will be completed by authorised facility staff using routinely collected facility wide data.
Timepoint [5] 400072 0
Three month period seasonally controlled, pre and post intervention period.
Secondary outcome [6] 400073 0
Number of severe responsive behaviours in the facility. A study-specific survey will be completed by authorised facility staff using routinely collected facility wide data.
Timepoint [6] 400073 0
Three month period seasonally controlled, pre and post intervention period.
Secondary outcome [7] 401163 0
Falls rates per 1000 bed days (inside and outside). A study-specific survey will be completed by authorised facility staff using routinely collected facility wide data.
Timepoint [7] 401163 0
Three month period seasonally controlled, pre and post intervention period.
Secondary outcome [8] 401164 0
Number of residents falling inside. A study-specific survey will be completed by authorised facility staff using routinely collected facility wide data.
Timepoint [8] 401164 0
Three month period seasonally controlled, pre and post intervention period.
Secondary outcome [9] 401879 0
Family member/visitor perceptions of changes in practices to improve access to RACF outdoor spaces. This will be collected through 1 hour focus groups and/or 15-30 minute interviews with up to a total of 10 family members/visitors at each facility. All family members/visitors known to participating facilities will be invited to participate and the first 10 eligible and consenting respondents will take part. The questions have been designed specifically for this study.
Timepoint [9] 401879 0
Interviews and focus groups will occur in the six weeks immediately post intervention.
Secondary outcome [10] 401882 0
Number of residents falling outside. A study-specific survey will be completed by authorised facility staff using routinely collected facility wide data.
Timepoint [10] 401882 0
Three month period seasonally controlled, pre and post intervention period.

Eligibility
Key inclusion criteria
All residents, their family/carers and facility staff at each site are eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any resident or family unable to verbally communicate in English will not be eligible to participate. Staff who are unable to read English may not be able to complete the staff surveys.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Each site will implement a tailored intervention that is based on the priorities and needs of each site. Data collection will compare care provided to patients before and after the intervention is implemented at each site (historical comparison group).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As a pragmatic trial we have not performed a power analysis but include all residents, family, visitors and staff at the participating site as potential participants. The facility in total have capacity to accommodate 124 residents. Routinely collected data will be collected at a facility level for all residents and robust qualitative data is based on richness rather than sample sizes.

Quantitative data: We will use frequencies to describe the extent to which staff perceived each project goal to be achieved using the Goal Attainment Scale. Using facility wide staff surveys we will compare pre- and post- survey responses regarding staff perceptions of outdoor usage using t-tests and chi-square tests (or relevant non-parametric data where data is not normally distributed). These statistic will also be used to compare pre and post- intervention data for number of outdoor activities organised by the activities coordinator/lifestyle staff, number of mental health referrals, number of severe episodes of responsive behaviours and number of falls and falls per 1000 bed days (inside and outside). For these measures we will retrospectively collect 12 months of data pre-intervention. Post intervention we will collect equivalent routinely collected data for a 3 month period. This will allow for a seasonal adjustment to compare an equivalent three months pre and post intervention.

Qualitative data: The policy audit and environmental audit data are descriptive summarising key strengths and limitations of existing policy and the outdoor environment to inform the intervention. We will qualitatively assess using descriptive methods whether there have been any changes in policies from baseline to post-intervention and assess whether any changes are considered enhancement in policy to improve the safe use of outdoor spaces. Post-intervention focus groups will be audio-recorded and transcribed verbatim. Transcripts will be thematically analysed using NVivo software to enable line-by-line coding. We will group codes into broader themes. The themes will help us explore what changes were made due to the intervention and whether further changes are required. These findings will also provide resident and family perspectives on the impact of the intervention. This will provide rich data in which to analyse the impact of the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/11/2021
Actual
10/10/2022
Date of last participant enrolment
Anticipated
28/01/2023
Actual
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
100
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38929 0
3028 - Altona Meadows

Funding & Sponsors
Funding source category [1] 309502 0
Other Collaborative groups
Name [1] 309502 0
Melbourne Ageing Research Collaboration
Country [1] 309502 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Melbourne Ageing Research Collaboration
Address
34-54 Poplar Road Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 310748 0
None
Name [1] 310748 0
Address [1] 310748 0
Country [1] 310748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309288 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 309288 0
Ethics committee country [1] 309288 0
Australia
Date submitted for ethics approval [1] 309288 0
20/07/2021
Approval date [1] 309288 0
28/10/2021
Ethics approval number [1] 309288 0
165/21

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

Contacts
Principal investigator
Name 113638 0
Ms Sue Williams
Address 113638 0
National Ageing Research Institute
34-54 Poplar Road Parkville VIC 3052
Country 113638 0
Australia
Phone 113638 0
+61 383872614
Fax 113638 0
Email 113638 0
[email protected]
Contact person for public queries
Name 113639 0
Sue Williams
Address 113639 0
National Ageing Research Institute
34-54 Poplar Road Parkville VIC 3052
Country 113639 0
Australia
Phone 113639 0
+61 383872614
Fax 113639 0
Email 113639 0
[email protected]
Contact person for scientific queries
Name 113640 0
Kayla Lock
Address 113640 0
National Ageing Research Institute
34-54 Poplar Road Parkville VIC 3052
Country 113640 0
Australia
Phone 113640 0
+61 38387 2305
Fax 113640 0
Email 113640 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
Our ethically approved protocol states information collected will only be used for the purpose of the research project and it will only be disclosed with participant’s permission, except as required by law.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12968Study protocol  [email protected]
12969Informed consent form  [email protected]
12970Ethical approval  [email protected]



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.