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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]

nil known

Universal Trial Number (UTN)

U1111-1306-1500

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

falls

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

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]

Prevention

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of the Rapid-Response Fall-Risk Assessment and Management Service Tools in the community aged care setting.

Timepoint [1]

Immediately post pilot testing (three-month period) of the Rapid-Response Fall-Risk Assessment and Management Service Tools.

Primary outcome [2]

Useability of the Rapid-Response Fall-Risk Assessment and Management Service Tools in the community aged care setting.

Timepoint [2]

Immediately post pilot testing (three-month period) of the Rapid-Response Fall-Risk Assessment and Management Service Tools.

Primary outcome [3]

Suitability of the Rapid-Response Fall-Risk Assessment and Management Service Tools in the community aged care setting.

Timepoint [3]

Immediately post pilot testing (three-month period) of the Rapid-Response Fall-Risk Assessment and Management Service Tools.

Secondary outcome [1]

Nil

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Ageing Futures Institute, UNSW

Address [1]

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

HammondCare

Address [2]

Country [2]

Australia

Primary sponsor type

Individual

Name

Lindsey Brett

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of New South Wales Research Ethics Committee A

Ethics committee address [1]

https://research.unsw.edu.au/research-ethics-and-compliance-support-recs

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/05/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This project aims to develop and then pilot the following:
(i) An evidence-based risk stratification algorithm for use by home care staff to identify deteriorating aged care clients who are at high fall-risk, drawing on recently available guidelines, followed by;

(ii) A structured mobility and falls assessment, using evidence-based tools, able to be delivered rapidly by a virtual (i.e., telehealth / videoconference enabled) consultation with an AHP aided by a member of the clients’ usual care team being present in the client’s home.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lindsey Brett

Address

HammondCare, 4 Spicer Avenue, Hammondville, NSW 2170

Country

Australia

Phone

+61287883900

Fax

[email protected]

Contact person for public queries

Name

Lindsey Brett

Address

HammondCare, 4 Spicer Avenue, Hammondville, NSW 2170

Country

Australia

Phone

+61287883900

Fax

[email protected]

Contact person for scientific queries

Name

Lindsey Brett

Address

HammondCare, 4 Spicer Avenue, Hammondville, NSW 2170

Country

Australia

Phone

+61287883900

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21980	Study protocol					387571-(Uploaded-01-05-2024-16-13-41)-Study-related document.pdf
21981	Ethical 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.

Trial Review

Documents added manually

Documents added automatically