Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001395729p
Ethics application status
Submitted, not yet approved
Date submitted
13/10/2022
Date registered
1/11/2022
Date last updated
1/11/2022
Date data sharing statement initially provided
1/11/2022
Type of registration
Prospectively 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] 308187 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 327928 0
Wellbeing 327929 0
Condition category
Condition code
Public Health 324996 324996 0 0
Health service research
Injuries and Accidents 325103 325103 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 cluster RCT. 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 early 2023. 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. During this wash-in period, we will conduct two 1-hour training – (1) to describe the nature of the dashboard (e.g., its contents) and (2) to demonstrate how it is used using various real-life scenarios. The training will be conducted for all staff involved in resident care across the intervention sites.
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). The intervention involves implementing 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. The dashboard is based on a dynamic risk predictive and monitoring tool that was developed using multiple electronic databases (e.g., medications, incident reports, demographic and health status). It provides real-time person-centred actionable recommendations to prevent falls. The dashboard will be used on a daily basis as part of routine resident care.
Staff and Macquarie University researchers will embed the dashboard within the care management systems within facilities and access via routine avenues within the facility (i.e. computer/tablet). The dashboard utilizes data already collected within Anglicare's electronic care management system to provide information on well-being scores and incorporate a dynamic falls risk predictive tool to inform residents of 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.
Intervention code [1] 324635 0
Prevention
Intervention code [2] 324723 0
Treatment: Other
Comparator / control treatment
Usual care. The usual fall prevention program involves a manual process of post-fall risk assessment and interventions. It does not involve proactive measures to prevent falls.
Control group
Active

Outcomes
Primary outcome [1] 332810 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 in the existing aged care provider electronic system. The incident reports database contains falls incident-related information such as type of incident (e.g., injurious falls), date and time of incidents and hospitalization status (e.g., transfer to hospital required).
Timepoint [1] 332810 0
Intervention: 0 months (baseline), 12 months (primary timepoint) post-intervention wash-in period.
Control: 0 months (baseline), 12 months (primary timepoint) post-intervention wash-in period.
Secondary outcome [1] 414753 0
Rate of injurious falls per 1000 resident-day (i.e. Falls resulting in some form of body injury) extracted from incident reports in the existing aged care provider electronic system.
Timepoint [1] 414753 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [2] 414754 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 in the existing aged care provider electronic system.
Timepoint [2] 414754 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [3] 414755 0
The proportion of residents experiencing at least one fall extracted from incident reports in the existing aged care provider electronic system.
Timepoint [3] 414755 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [4] 414756 0
Change in QoL of the residents as measured by the Quality Of Life Aged Care Consumers (QOL-ACC) tool.
Timepoint [4] 414756 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [5] 414757 0
Attendance at leisure and lifestyle activities (a composite measure) during the study period as measured by aged care staff. This is measured using a structured data collection tool already implemented in the study sites and electronically available in the aged care provider electronic system.
Timepoint [5] 414757 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [6] 414758 0
The number of ED and or inpatient hospital admissions (as a composite measure) during the study period. This data will be obtained from hospitalisations records using the New South Wales's Emergency Department Data Collection (EDDC) and Admitted Patient Data Collection (APDC) databases.
Timepoint [6] 414758 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [7] 414759 0
The number of Peninsula Health Falls Risk Assessment Tool (PH-FRAT) assessments and actions (as a composite measure) taken during the study period. This data will be obtained from the aged care provider's FRAT database contains information on the existing falls risk assessment tool (PH-FRAT).
Timepoint [7] 414759 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.
Secondary outcome [8] 414760 0
Change in Falls Risk Increasing Drugs (FRIDs) e,g, antipsychotics. This data will be obtained from the aged care provider's electronic medication administration database which contains information on medications each resident received on daily basis.
Timepoint [8] 414760 0
Intervention: 0 months (baseline), 12 months post-intervention wash-in period.
Control: 0 months (baseline), 12 months post-intervention wash-in period.

Eligibility
Key inclusion criteria
Residential aged care facilities owned by a partner provider. No participant-specific inclusion criteria.
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 concealed at the cluster/group level. This will be conducted using a computer software program generated random allocation numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation is employed using facility size and the proportion of dementia residents in the stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312443 0
Government body
Name [1] 312443 0
National Health and Medical Research Council
Country [1] 312443 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
75 Talavera Rd, North Ryde NSW 2113
Australia
Country
Australia
Secondary sponsor category [1] 314021 0
None
Name [1] 314021 0
Address [1] 314021 0
Country [1] 314021 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311789 0
Macquarie University Human Research Ethics Committee: Medical Sciences
Ethics committee address [1] 311789 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Ethics committee country [1] 311789 0
Australia
Date submitted for ethics approval [1] 311789 0
17/10/2022
Approval date [1] 311789 0
Ethics approval number [1] 311789 0

Summary
Brief summary
We will implement an intervention to improve the quality of care for residents in aged care facilities. The intervention consists of an electronic dashboard on falls and quality of life. It is intended for use by aged care staff and predicts the risk of falls and poor well-being and presents information, action areas and clinical evidence-based recommendations that can be inputted by staff to minimize the resident risk of poor health outcomes. To evaluate the dashboard we will be conducting a cluster-randomised controlled trial where we will randomise 20 facilities into intervention and control groups (i.e. 10 in each group). The intervention will be introduced across all intervention sites at the same time in early 2023. 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 sites for the pilot testing.
The primary outcome we will look at is the rate of all falls (i.e., any falls regardless of whether an injury was involved, or hospitalisation was required). We hypothesise that the intervention will reduce the rate of falls in the intervention group in comparison to the facilities in the control group. The secondary outcomes include: injurious falls, falls requiring hospitalisation, client wellbeing, social service use (attendance at leisure and lifestyle activities), hospital service use, use of the Peninsula Health Falls Risk Assessment Tooland change in use of Falls-Risk Increasing Drug use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122370 0
Prof Johanna Westbrook
Address 122370 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Country 122370 0
Australia
Phone 122370 0
+61 2 98502402
Fax 122370 0
Email 122370 0
johanna.westbrook@mq.edu.au
Contact person for public queries
Name 122371 0
Dr Nasir Wabe
Address 122371 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Country 122371 0
Australia
Phone 122371 0
+61 2 98502442
Fax 122371 0
Email 122371 0
nasir.wabe@mq.edu.au
Contact person for scientific queries
Name 122372 0
Dr Nasir Wabe
Address 122372 0
Macquarie University, 75 Talavera Rd, North Ryde NSW 2113
Country 122372 0
Australia
Phone 122372 0
+61 2 98502442
Fax 122372 0
Email 122372 0
nasir.wabe@mq.edu.au

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.