Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000909426
Ethics application status
Approved
Date submitted
1/07/2025
Date registered
21/08/2025
Date last updated
21/08/2025
Date data sharing statement initially provided
21/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation and evaluation of a dashboard of predictive analytics and decision support to drive care quality and person-centred outcomes in aged care
Scientific title
Implementation and evaluation of a dashboard of predictive analytics and decision support to drive care quality and person-centred outcomes in aged care: a pragmatic cluster randomised controlled trial
Secondary ID [1] 308168 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 327888 0
Wellbeing 338628 0
Condition category
Condition code
Public Health 324974 324974 0 0
Health service research
Injuries and Accidents 334820 334820 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a two-arm, parallel-group, non-blinded, pragmatic cRCT with baseline measurement. Randomisation will be stratified by the size and location of the facilities with a 1:1 allocation ratio. The unit of randomisation will be a cluster (i.e., residential aged care facilities). The intervention sites will receive the dashboard of predictive analytics and decision support while the control sites will remain on usual care (i.e., no dashboard). The 20 study sites (10 intervention and 10 control sites) will be randomly selected from a total of 24 facilities managed by Anglicare. The intervention will be introduced across all intervention sites at the same time in Nov 2024. A 1-month intervention wash-in period will be allowed to allow the integration of the dashboard into routine practice. Since the intervention is an add-on to an existing system, 1 month will be sufficient to allow users to familiarise themselves with the dashboard. The impacts of the dashboard will then be compared between the intervention and the control sites after 12 months (excluding the wash-in period data). We will include two additional site for the pilot testing.

The intervention involves the implementation of a dashboard of predictive analytics and decision support to be used by aged care staff to improve the care of residential aged care clients in relation to falls related hospitalizations and quality of life. Staff and Macquarie University researchers will embed the dashboard within the care management systems within facilities and accessed via routine avenues within the facility (i.e. computer/tablet).. The dashboard utilizes data that has already been collected within Anglicare's electronic care management system to provide information on wellbeing scores as well as incorporating a dynamic falls risk predictive tool to inform residents daily falls risk. The dashboard will be used by staff in addition to other standard electronic and paper-based forms used to provide standard care. The dashboard will also include interventions or recommended actions to take to reduce resident falls risk based on clinical guidelines and the Peninsula Health Falls Risk Assessment Tool (PH-FRAT), commonly used in residential aged care. The content, design and functionality of the dashboard have been co-developed to ensure that it is suitable for implementation and use by staff. It is considered complementary to standard care.

Access to four datasets was obtained: the resident profile (includes residents’ demographics and admission information); all medications administered to residents; the organization’s PH-FRATs (this aged care providers used the PH-FRAT) to obtain information related to falls risk assessments; and incident dataset (includes information related to all fall incidents and pressure injuries;
The profile dataset included a free text field that reported the comorbidities along with other special needs of the patient at admission (ie, health status). From this field, comorbidities present at admission were identified using the R-programmed version of the “aged care health status algorithm” within PBI. The algorithm identifies the health conditions using free text fields from EHRs. All medications in the dataset were coded using the Anatomical Therapeutic Chemical codes. These datasets were then linked in the dashboard backend.
The extracted datasets for the study period underwent an external analysis for this study using R programming language (version 4.3.3; R Core Team) and were also subsequently used for its intended purpose within PBI. A descriptive analysis of the admission-related information from the resident profile dataset is reported appropriately.
Resident characteristics from the resident profile dataset, FRAT dataset, and daily medication administration data are recorded.

MQ-Dash is a system used to present data already extracted from other Anglicare systems, there is no data input required to use MQ-Dash and therefore there is no time burden on staff.

The dashboard practice points are taken from a rapid literature review conducted by the MQ team. Examples of practice points from MQ-Dash include: recommending a medication review with resident medical team, environmental recommendations such as clearing the floors of any potential trip hazards, extra resident supervision.

To monitor use of MQ-Dash a study specific questionnaire is used at the 3-month, 6-month and 12-month check-in point for the trial. This has questions on frequency of MQ-Dash use. For MQ-Dash usage we also use PowerBI analytics, which reports which users have opened and used MQ-Dash.
Intervention code [1] 324613 0
Prevention
Comparator / control treatment
Usual care is defined as the standard care practices that continue unchanged during the intervention period. Facilities assigned to control arm will continue the usual care which will not receive access to the dashboard or any related interventions arise from the dashboard (e.g. email reports).
Control group
Active

Outcomes
Primary outcome [1] 332776 0
Rate of all falls per 1000 resident-day (i.e., any falls regardless of whether an injury was involved, or hospitalisation was required) extracted from incident reports
Timepoint [1] 332776 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation (primary timepoint) Control: 0 months (baseline), 12 months post-dashboard implementation (primary timepoint)
Secondary outcome [1] 414676 0
Rate of injurous falls per 1000 resident-day (i.e. Falls resulting in some form of body injury) extracted from incident reports
Timepoint [1] 414676 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [2] 414677 0
Rate of falls requiring hospitalisation per 1000 resident-day (i.e. Falls that required hospital admission for further investigation or care) extracted from incident reports
Timepoint [2] 414677 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [3] 414678 0
Proportion of residents experiencing at least one fall extracted from incident reports
Timepoint [3] 414678 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [4] 414718 0
Change in QoL of the residents as measured by the Quality Of Life Aged Care Consumers (QOL-ACC) tool
Timepoint [4] 414718 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [5] 414719 0
Attendance at leisure and lifestyle activity during the study period as measured by aged care staff
Timepoint [5] 414719 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [6] 414720 0
In the study we will be evaluating the number of falls that have been classified as ‘requiring hospitalisation’. This data is taken from PH-Frat assessments logged in the Anglicare system. We can access the number of falls requiring hospitalisation. However, this is only reported in the incident reports. Sometimes even though it is being recorded as "required hospitalisation", resident may choose not to go to hospital due to the falls incident
Timepoint [6] 414720 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [7] 414721 0
We will access the PH-FRAT assessment data from the aged care provider and analyse the prevalence of these assessments over the study period longitudinally for both control and intervention sites. To compare the difference in prevalence trends between the control and intervention arms, we will use a generalized estimating equations (GEE) approach with a logistic link (or alternatively, a mixed-effects logistic regression model) to account for repeated measures and clustering within sites.
Timepoint [7] 414721 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation
Secondary outcome [8] 414722 0
Change in Falls Risk Increasing Drugs (FRIDs) e,g, antipsychotics. To calculate this we will use daily medication administration records. FRIDs include medications (eg, antipsychotics) that increase fall risk through their effects on the central nervous system and medications (eg, beta blockers) that increase fall risk by causing orthostatic hypotension. We used the Anatomical Therapeutical Chemical (ATC) classification codes to identify these medications and access the incident rates.
Timepoint [8] 414722 0
Intervention: 0 months (baseline), 12 months post-dashboard implementation Control: 0 months (baseline), 12 months post-dashboard implementation

Eligibility
Key inclusion criteria
Residential aged care facilities owned by partner provider
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not a residential aged care provider
Not owned by partner provider

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312426 0
Government body
Name [1] 312426 0
National Health and Medical Research Council
Country [1] 312426 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
75 Talavera Rd, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 314002 0
None
Name [1] 314002 0
Address [1] 314002 0
Country [1] 314002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311771 0
Macquarie University Human Research Ethics Committee: Medical Sciences
Ethics committee address [1] 311771 0
Ethics committee country [1] 311771 0
Australia
Date submitted for ethics approval [1] 311771 0
17/10/2022
Approval date [1] 311771 0
17/11/2022
Ethics approval number [1] 311771 0

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

Contacts
Principal investigator
Name 122310 0
Prof Johanna Westbrook
Address 122310 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Country 122310 0
Australia
Phone 122310 0
+61 2 98502402
Fax 122310 0
Email 122310 0
[email protected]
Contact person for public queries
Name 122311 0
Nasir Wabe
Address 122311 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Country 122311 0
Australia
Phone 122311 0
+61 2 98502442
Fax 122311 0
Email 122311 0
[email protected]
Contact person for scientific queries
Name 122312 0
Nasir Wabe
Address 122312 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Country 122312 0
Australia
Phone 122312 0
+61 2 98502442
Fax 122312 0
Email 122312 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data is owned by a third party, with access restricted to those approved by the data custodians. In addition, the data contains sensitive information regarding the private health information of individuals. We will be applying for permission to use and analyse the data for our project under strict ethical approvals. Data will be stored on password-protected MQ university Sharepoint, accessible only to study investigators, used only in accordance with the study protocol, and destroyed after 7 years following the publication of the main findings. Data may be transferred to MQ RDR will full restrictions (no access) with the stipulation to be destroyed after 7-years pending approval from the appropriate data custodians and ethics committee.



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.