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Trial registered on ANZCTR


Registration number
ACTRN12624000647538p
Ethics application status
Submitted, not yet approved
Date submitted
1/05/2024
Date registered
20/05/2024
Date last updated
20/05/2024
Date data sharing statement initially provided
20/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and pilot of a rapid-response, virtual, fall-risk assessment and management service for community-dwelling aged care clients.
Scientific title
Development and pilot of a rapid-response, virtual, fall-risk assessment and management service for community-dwelling aged care clients.
Secondary ID [1] 311825 0
nil known
Universal Trial Number (UTN)
U1111-1306-1500
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 333361 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330045 330045 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 330454 330454 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A mixed-methods three-phase study, with each phase informing subsequent phases has been selected to address the study aim (develop and pilot test a rapid-response falls risk assessment and management service tool).

Stage 1: Community aged care staff and Allied Health Professionals (AHPs) focus groups (total duration: 2 months) - DEVELOPMENT STAGE
Focus groups will be conducted online (via Microsoft Teams) by a member of the research team. Participants will be HammondCare at Home (HC@H) clinical and client care managers, and HammondCare Restorative Care Team AHPs. Multiple focus groups will be scheduled over a 4 week period to accommodate all participants. However, each participant will only attend one focus group, which will run for 1 hour.

The focus groups will discuss findings from a scoping literature review, the key topics will be focused on current evidence on falls risk assessments and interventions for older adults, and virtual delivery of healthcare services in the community. The focus groups will be conducted to ensure that the rapid-response falls risk assessment and management service tool is not only theoretically sound but also practically applicable and able to be effectively delivered in the community aged care context, including within the scope of practice of community aged care staff (care worker, clinical manager, client care managers) and AHPs.

Strategies used to monitor adherence to intervention will not be required at this stage as it is a developmental stage, participation is voluntary, and participants are only required to attend one focus group.


Stage 2: Rapid-response falls risk assessment and management service tool development (total duration: 2 months) - DEVELOPMENT STAGE
This stage focuses on development of the two components of the tool, building on insights from Stage 1:
(i) A falls risk stratification algorithm that can be used by community aged care staff to identify deteriorating clients at an increased risk of falls. This could be either a paper-based or a dynamic questionnaire built into HC@H’s client management software.
(ii) Collation of a focussed set of evidence-based falls risk assessments and interventions that can be incorporated into an AHP assessment and able to be conducted virtually with the client (with the support of a HC@H staff member present in the home if needed).

Once the tool has been developed, participants (i.e. HC@H clinical and client care managers, and HammondCare Restorative Care Team AHPs) will be asked to work through real-world case scenarios using either the falls risk stratification algorithm (HC@H care workers and clinical and client care managers) or the virtual AHP falls risk assessment (HammondCare Restorative Care Team AHPs). This activity will take 30 minutes to complete, each participant will only have to complete this activity once. Possible scearios will include falls incidents (e.g. older adult falls outside whilst completing a functional task, older adult has a near miss fall whilst the HC@H csre worker is present) and changes/deterioration in mobiltiy or function (e.g. carer of the older adult reports a deterioation in mobility when out in the community. older adult reports an increased concern about falling when completing a household task).

Participate will then complete one online interview (via Microsoft Teams) one-to-one with a member of the research team to discuss the component of the tool they reviewed and their experience in completing the real-world scenario. This activity will take 30 minutes to complete.

Strategies used to monitor adherence to intervention will not be required at this stage as it is a developmental stage, participation is voluntary, and participants are only required to attend one interview.


Stage 3: Pilot of the rapid-response falls risk assessment and management service tool (total duration: 4 months) - INTERVENTION STAGE
This stage will assess the practicality and effectiveness of the developed tool in a community aged care service, incorporated into routine practice (when indicated). The falls risk stratification algorithm will be pilot tested by HC@H staff and clients; the virtual AHP falls risk assessment to be pilot tested by HammondCare Restorative Care Team AHPs and clients, with the support of a HC@H care worker or manager being present in the home. Examples of support may include assistance with use of the technology to access the virtual assessment, supervision when completing relevant assessment tasks, and further explanation of how to compelte an assessment task or intervention recommendation.

HC@H staff and HammondCare Restorative Care Team AHPs will recevie training on the use of the rapid-response falls risk assessment and management service tool, and how to incorporate it into routine practice. Training sessions will be scheduled during a 2-week period prior to recruitment for Stage 3. Participants will only be required to attend one training session in this time. The training sessions will be conducted by a member of the research team online (via Microsoft Teams). The sessions will be recorded to allow participsants to re-watch them as required during this Stage. They will also be proivded with a training pack (via email or saved to a HammondCare shared folder) they can refer to that summarises the key points of the training session.

The piloting of both the falls risk stratification algorithm and virtual AHP falls risk assessment will include a focus on the clinical utility, user acceptance, and ability for the rapid-response falls risk assessment and management service tool to be incorporated into routine practice. Pilot data will be collected from clinical records, an anonymous online survey completed by HC@H staff and HammondCare Restorative Care Team AHPs at the end of Stage 3, and an online Patient-Reported Experience Measure (PREM) survey (a paper-based alternative will be provided if needed/request) completed by HC@H clients after completion of their participation in Stage 3. The PREM survey will not be anonymous to allow for linkage with client demographic and clinical outcome data during the analysis stage. Clinical records and online surveys will also be reviewed to assess adherence and fidelity to the rapid-response falls risk assessment and management service tool.

Once the virtual AHP falls risk assessment has been completed, the AHP’s recommendations will be reported back to the client's HC@H clinical or client care (as appropriate) manager. Potential options may include a virtually delivered falls prevention program, a face-to-face AHP visit, liaison with GP or other usual care, which are all currently available services from HammondCare and are not the subject of this research (which is focussed on the development and pilot of the falls risk stratification algorithm and the virtual AHP falls risk assessment).
Intervention code [1] 328285 0
Prevention
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337806 0
Feasibility of the Rapid-Response Fall-Risk Assessment and Management Service Tools in the community aged care setting.
Timepoint [1] 337806 0
Immediately post pilot testing (three-month period) of the Rapid-Response Fall-Risk Assessment and Management Service Tools.
Primary outcome [2] 338223 0
Useability of the Rapid-Response Fall-Risk Assessment and Management Service Tools in the community aged care setting.
Timepoint [2] 338223 0
Immediately post pilot testing (three-month period) of the Rapid-Response Fall-Risk Assessment and Management Service Tools.
Primary outcome [3] 338224 0
Suitability of the Rapid-Response Fall-Risk Assessment and Management Service Tools in the community aged care setting.
Timepoint [3] 338224 0
Immediately post pilot testing (three-month period) of the Rapid-Response Fall-Risk Assessment and Management Service Tools.
Secondary outcome [1] 435052 0
Nil
Timepoint [1] 435052 0
Nil

Eligibility
Key inclusion criteria
Stage 1
HammondCare at Home managers:
Clinical or client care manager for HC@H at the time of the study.
18 years or older.
Provide written, informed consent.

HammondCare Restorative Care Team AHPs:
Physiotherapist, Occupational Therapist (OT), or Exercise Physiologist (EP) that are part of HammondCare’s Restorative Care Team at the time of the study.
18 years or older.
Provide written, informed consent.

Stage 2
HammondCare at Home staff:
Care workers, or clinical or client care manager for HC@H at the time of the study.
18 years or older.
Provide written, informed consent.

HammondCare Restorative Care Team AHPs:
Physiotherapist, Occupational Therapist (OT), or Exercise Physiologist (EP) that are part of HammondCare’s Restorative Care Team at the time of the study.
18 years or older.
Provide written, informed consent.

Stage 3
HammondCare at Home clients:
HammondCare at Home client at the time of the study.
Aged 65 years or older.
Provide written, informed consent to invovlement in this project.

HammondCare at Home staff:
Care workers, or clinical or client care manager for HC@H at the time of the study.
18 years or older.
Provide written, informed consent.

HammondCare Restorative Care Team AHPs:
Physiotherapist, Occupational Therapist (OT), or Exercise Physiologist (EP) that are part of HammondCare’s Restorative Care Team at the time of the study.
18 years or older.
Provide written, informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stage 1
HammondCare at Home managers:
Work outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.

HammondCare Restorative Care Team AHPs:
AHPs other than those specified in the inclusion criteria.
Work outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.

Stage 2
HammondCare at Home staff:
Work outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.

HammondCare Restorative Care Team AHPs:
AHPs other than those specified in the inclusion criteria.
Work outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.

Stage 3
HammondCare at Home clients:
Reside outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.
Insufficient English proficiency that prevents involvement in the virtual AHP falls risk assessment or survey.
Cognitive impairment that prevents their ability to provide informed consent.
Identified as at risk of falls and requires same day/urgent attention/referral as part of their usual care (e.g. urgent GP review due to a syncopal episode, same day review in the Emergency Department due to suspected head injury or fracture).

HammondCare at Home staff:
Work outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.

HammondCare Restorative Care Team AHPs:
AHPs other than those specified in the inclusion criteria.
Work outside of New South Wales (NSW), Australian Capital Territory (ACT), and Victoria.

Study design
Purpose of the study
Prevention
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
Safety/efficacy
Statistical methods / analysis
Qualitative analysis:
A phenomenology methodology will be adopted for the analysis of qualitative data from all stages (transcripts from focus groups, interviews, and open-ended survey responses). This approach is designed to capture the lived experiences and perceptions of participants, focusing on their subjective experiences and interpretations. Thematic analysis using an inductive framework will be conducted to identify, analyse, and report themes within the data in NVivo. Two investigators will independently code the data, grouping similar content into themes that emerge directly from the data. A third investigator will review discrepancies to ensure consensus is reached.

Quantitative analysis:
Descriptive methods in SPSS will be used to summarise the client demographics and PREM survey results to get an overview of participant characteristics, participant experiences, and user acceptance. Clinical utility and operational feasibility will be considered through analyse of frequency of falls risk stratification algorithm use, time taken to complete assessments, recruitment rates, assessment outcomes and recommendations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
13/01/2025
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC

Funding & Sponsors
Funding source category [1] 316165 0
University
Name [1] 316165 0
Ageing Futures Institute, UNSW
Country [1] 316165 0
Australia
Funding source category [2] 316173 0
Commercial sector/Industry
Name [2] 316173 0
HammondCare
Country [2] 316173 0
Australia
Primary sponsor type
Individual
Name
Lindsey Brett
Address
Country
Australia
Secondary sponsor category [1] 318345 0
None
Name [1] 318345 0
Address [1] 318345 0
Country [1] 318345 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314990 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 314990 0
Ethics committee country [1] 314990 0
Australia
Date submitted for ethics approval [1] 314990 0
02/05/2024
Approval date [1] 314990 0
Ethics approval number [1] 314990 0

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

Contacts
Principal investigator
Name 133342 0
Dr Lindsey Brett
Address 133342 0
HammondCare, 4 Spicer Avenue, Hammondville, NSW 2170
Country 133342 0
Australia
Phone 133342 0
+61287883900
Fax 133342 0
Email 133342 0
lbrett@hammond.com.au
Contact person for public queries
Name 133343 0
Lindsey Brett
Address 133343 0
HammondCare, 4 Spicer Avenue, Hammondville, NSW 2170
Country 133343 0
Australia
Phone 133343 0
+61287883900
Fax 133343 0
Email 133343 0
lbrett@hammond.com.au
Contact person for scientific queries
Name 133344 0
Lindsey Brett
Address 133344 0
HammondCare, 4 Spicer Avenue, Hammondville, NSW 2170
Country 133344 0
Australia
Phone 133344 0
+61287883900
Fax 133344 0
Email 133344 0
lbrett@hammond.com.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21980Study protocol    387571-(Uploaded-01-05-2024-16-13-41)-Study-related document.pdf
21981Ethical approval    Will be uploaded once available.



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.