Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000096358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/12/2025
Date registered
Help: Date registered
23/01/2026
Date last updated
Help: Date last updated
23/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and impact of SAIFR (Systematic Approach to the Implementation of Falls Recommendations) for older clients in community rehabilitation: a pilot cluster randomised trial
Scientific title
Feasibility and impact of SAIFR (Systematic Approach to the Implementation of Falls Recommendations) for older clients in community rehabilitation: a pilot cluster randomised trial
Additional trial identifiers [1] 316201 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SAIFR
Related trial records

Health condition
Health condition(s) studied:
Falls 340194 0
Condition category
Condition code
Public Health 336389 336389 0 0
Health service research
Injuries and Accidents 336390 336390 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a hybrid type 2 pilot stepped wedge randomised controlled trial comprising two sites. It will evaluate the feasibility and impact of SAIFR (Systematic Approach to the Implementation of Falls Recommendations) in the community rehabilitation program setting. The World Guidelines for Falls Prevention and Management for Older Adults and the Preventing Falls and Harm from Falls in Older People: Best Practice Guidelines for Community Care in Australia will be implemented, following the SAIFR approach. The trial coordinator implementing the falls guidelines is a physiotherapist with over 20 years clinical experience.
The target population of this study will be clients of the community rehabilitation program who are seen by occupational therapy or physiotherapy and are aged 65 years or over from whom routinely collected data and survey responses will be analysed. These clients will also be invited to participate in a semi-structured interview to describe their experience with the SAIFR implementation intervention, as will the occupational therapists and physiotherapists of the community rehabilitation program.
As part of the intervention, in comparison to usual care, clients will receive fall prevention care that more closely and consistently aligns to the recommendations in the World Falls Guidelines and Australian Falls Guidelines for community dwelling older people, including tailored education on physical activity, tailored education on falls prevention, progressive balance, strength and mobility exercises, home hazard reduction and interventions tailored according to fall risk assessment. They will receive behaviour change support from their therapists to help make necessary changes to reduce their falls risk.
The pilot trial will commence with a period of usual care that will extend for 3 months at one community rehabilitation program site (site 1) and 6 months for the second community rehabilitation program site (site 2). Pre-implementation (baseline) data will be collected during this time. The order of commencement of implementation will be randomly determined with a coin toss. The implementation intervention will be delivered in site 1 over a 3-month period and then, in turn, will be delivered in site 2, also over a 3-month period. The implementation strategies for therapists will involve:
-1 hour training and education session about the World Falls Guidelines and Australian Falls Guidelines (broadly and specifically aligned to the community settings). One training and education session will occur per site, during the implementation phase. The training and education session will be conducted in-person and a recording will also be made available for therapists who cannot attend on the day. Attendance at the training and education session will be recorded. The education session will include an introduction regarding the trial, the problem of falls, the challenge of implementing fall prevention guidelines in health services, orientation to the World Falls Guidelines, strength and source of recommendations, a summary of general falls prevention recommendations from the World Falls Guidelines, key themes from recommendations in the World Falls Guidelines, orientation to the Australian Falls Guidelines, differences between the World Falls Guidelines and Australian Falls Guidelines, a summary of general falls prevention recommendations from the Australian Falls Guidelines, key themes from recommendations in the Australian Falls Guidelines, community-specific recommendations from both the World Falls Guidelines and Australian Falls Guidelines.
-2 hour training and planning workshop. One workshop will occur per site, during the implementation phase. The workshop will be conducted in-person. Attendance at the training and planning workshop will be recorded. The workshop will include an introduction regarding the trial, recap of key points from training and education session, mapping of the current journey of clients at risk of falls in the Community Rehabilitation Program, consideration of current gaps according to the COM-B framework of behaviour change, consideration of integration of recommendations within existing processes, sharing of possible resources/training/support that could be considered, planning for next steps.
-development and enhancement of local processes, including documentation. For example, existing assessment forms may require edits to improve adherence with recommendations, existing telephone triage questions may need to be adapted, processes for referrals for other health professional input may need to be streamlined. This will be determined in collaboration with the therapists working in the Community Rehabilitation Program.
-promotion of the World Falls Guidelines and Australian Falls Guidelines by the project lead, including responding to questions, attending appropriate team meetings and providing regular updates in-person and via email. Other promotional material and/or strategies will be determined in collaboration with the therapists working in the Community Rehabilitation Program.
Implementation strategies will be guided by the COM-B model of behaviour change. A post-implementation period of 6 months at site 1 and 3 months at site 2 will follow implementation at each site, during which time post-implementation data will be collected, including semi-structured interviews of clients and therapists.
Intervention code [1] 332825 0
Prevention
Intervention code [2] 332826 0
Behaviour
Description of the comparator or control
The pre-implementation phase (usual care) for 3 months at site 1 and 6 months at site 2 will be the comparator. Usual care within the community rehabilitation program involves home-based or centre-based therapeutic management of injuries and health conditions which may include some fall prevention interventions. Examples of usual care fall prevention interventions include home assessments, gait re-education and provision of a written fall prevention brochure.
Control group
Active

Outcomes
Primary outcome [1] 343910 0
Impact (reach): Proportion of older clients (65 or older) seen by occupational therapy or physiotherapy (or both) with evidence of engagement with one of the key recommendations aligned to community fall prevention, i.e.: fall risk screening as per guidelines, at least one fall risk with actioned intervention, education on physical activity / fall prevention, home hazard reduction assessment /intervention or tailored / progressed exercise program
Timepoint [1] 343910 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Primary outcome [2] 343911 0
Impact (implementation): Proportion of clients completing the falls survey who have taken action to reduce falls
Timepoint [2] 343911 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Primary outcome [3] 343912 0
Trial feasibility (recruitment): Number of clients and therapists with completed semi-structured interviews (audio-recorded interviews of approximately 30 minutes, conducted by a member of the research team)
Timepoint [3] 343912 0
On completion of the post-implementation phase (12 months)
Secondary outcome [1] 456108 0
Impact (effectiveness): Proportion of older clients (65 and older) seen by occupational therapy and physiotherapy (or both) who fell during their episode of care with the community rehabilitation program (fall risk)
Timepoint [1] 456108 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [2] 456109 0
Impact (effectiveness): The rate of falls per episode of care for older clients (65 and older) seen by occupational therapy or physiotherapy (or both) in the community rehabilitation program (fall rate)
Timepoint [2] 456109 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [3] 456110 0
Impact (adoption): Proportion of occupational therapists and physiotherapists with evidence of delivering on one of three of the key recommendations aligned to community fall prevention, i.e.: actioning at least one intervention aligned to a fall risk, providing education on physical activity / fall prevention or prescribing a tailored / progressed exercise program. The components will also be evaluated individually.
Timepoint [3] 456110 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [4] 456112 0
Trial feasibility (data collection methods): Proportion of older clients (65 and older) seen by occupational therapy or physiotherapy (or both) who completed a falls survey
Timepoint [4] 456112 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [5] 456114 0
Trial feasibility (timely progression): Timely progression of steps in the study; progression to second site within 3 weeks of intended time frame and completion of implementation within intended time frame (3 months per site)
Timepoint [5] 456114 0
On completion of post-implementation phase (12 months)
Secondary outcome [6] 456115 0
Composite secondary outcome of trial feasibility (acceptability) and Impact (implementation): Engagement, satisfaction, participation and feedback of clients and occupational therapists and physiotherapists
Timepoint [6] 456115 0
Post-implementation phase
Secondary outcome [7] 456267 0
Impact (reach): Proportion of older clients (65 or older) seen by occupational therapy or physiotherapy (or both) with evidence of fall risk screening as per guidelines
Timepoint [7] 456267 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [8] 456268 0
Impact (reach): Proportion of older clients (65 or older) seen by occupational therapy or physiotherapy (or both) with evidence of at least one fall risk with actioned intervention
Timepoint [8] 456268 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [9] 456269 0
Impact (reach): Proportion of older clients (65 or older) seen by occupational therapy or physiotherapy (or both) with evidence of education on physical activity / fall prevention
Timepoint [9] 456269 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [10] 456270 0
Impact (reach): Proportion of older clients (65 or older) seen by occupational therapy or physiotherapy (or both) with evidence of home hazard reduction assessment /intervention
Timepoint [10] 456270 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [11] 456271 0
Impact (reach): Proportion of older clients (65 or older) seen by occupational therapy or physiotherapy (or both) with evidence of tailored / progressed exercise program
Timepoint [11] 456271 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the pre-implementation phase (baseline / usual care) and the post-implementation phase
Secondary outcome [12] 456272 0
Impact (implementation): Proportion of community rehabilitation clients aged 65 years or older and seen by occupational therapy or physiotherapy (or both) who participate in exercise interventions as intended
Timepoint [12] 456272 0
At 3 months post admission to the community rehabilitation program or discharge from the community rehabilitation program (whichever occurs sooner) during the post-implementation phase

Eligibility
Key inclusion criteria
Clusters will be two community rehabilitation program sites at Eastern Health.
Recruitment of participants is planned for semi-structured interviews only, as follows.
Clients:
Aged 65 years and older
Receive occupational therapy or physiotherapy care (or both) in the community rehabilitation program
Able to provide written, informed consent
Clinicians:
Occupational therapists and physiotherapists (18 years or older) of the community rehabilitation program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Clients:
Less than 65 years
Unable to provide written, informed consent
Requiring an interpreter to participate in an interview
Clinicians:
Nil

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 concealed. Centralised randomisation by an independent researcher, not involved in the study. After sites are enrolled, the independent researcher will contact the lead researcher by email with the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of the commencement of implementation with a coin toss by an independent researcher who is not otherwise involved in the trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge, cluster randomised controlled trial with two sites and two steps
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Reach outcomes:
The statistical comparison of the two groups (pre-implementation and post-implementation) will be assessed using a two proportion z-test of independent samples, with significance level set at 0.05.

The null hypothesis will be that there is no significant change in the proportion of clients reached (p<0.05) when comparing pre-implementation and post-implementation phases. The alternate hypothesis will be that will be a significant change in the proportion of clients reached (p<0.05) when comparing pre-implementation and post-implementation phases.

Effectiveness outcomes:
Power calculations have indicated that this study is not sufficiently powered to show a significant change in fall rates or fall risk and therefore effectiveness is included as a secondary outcome only, as follows:

Fall Risk: The proportion of community rehabilitation program clients aged 65 years or older reporting one fall, comparing the pre-implementation (control) and post-implementation (intervention) phases, descriptively.

Fall Rate: The number of falls per by community rehabilitation program clients aged 65 years or older and seen by occupational therapy or physiotherapy (or both) in the pre-implementation (control) phase will be compared with the number in the post-implementation (intervention) phase, descriptively.

Adoption outcomes:
Power calculations have indicated that this study is not sufficiently powered to show a significant change in fall rates or fall risk and therefore adoption is included as a secondary outcome only and descriptive statistics (e.g. total numbers, percentages) will be used to analyse adoption outcomes.

Implementation outcomes:
The proportion of community rehabilitation program clients aged 65 years or older and seen by occupational therapy or physiotherapy (or both) participating in exercise interventions as intended in the post-implementation phase will be analysed, based on medical record audit and client diaries. This content analysis of the exercise programs will include information regarding the frequency of exercise sessions, the number of missed or incomplete sessions, and the proportion of sessions completed under supervision.

The proportion of community rehabilitation program clients aged 65 years or older and seen by occupational therapy or physiotherapy (or both) who respond positively to the falls survey question – “While you have been a client at this community rehabilitation program, have you taken any action suggested by your therapists to reduce your risk of falls?” will be recorded, comparing the pre-implementation and post-implementation phases.

The statistical comparison of the two groups (pre-implementation and post-implementation) in regard to the falls survey question will be assessed using a two proportion z-test of independent samples, with significance level set at 0.05.

The null hypothesis will be that there is no significant change in the proportion of clients responding positively to the falls survey question (p<0.05) when comparing pre-implementation and post-implementation phases. The alternate hypothesis will be that will be a significant change in the proportion of clients responding positively to the falls survey question (p<0.05) when comparing pre-implementation and post-implementation phases.

Reflexive thematic analysis will be used to identify themes from the client and clinician interviews regarding their experience with the application of the Systematic Approach to the Implementation of Falls Recommendations (SAIFR) in the Community Rehabilitation Program. An inductive approach will be taken, where coding and theme development are directed by the content of the data rather than pre-determined. Steps will include familiarisation with the data through reading and re-reading transcripts, assignation of codes to words or short phrases that capture the essence of the content, grouping of codes into patterns or overarching ideas, refining and validating themes across entire dataset, defining and naming themes and then writing up and presenting the themes in line with the research question.

Feasibility of study methods:
The proportion of clients with a completed falls survey in both pre and post implementation phases will be calculated. The number of clients and clinicians with a completed interview will also be calculated. Whether the study progresses according to the anticipated timelines will be reported. Themes of engagement, satisfaction, participation and feedback will also be recorded in the Research Log and described narratively.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
28/02/2027
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29024 0
Wantirna Health - Wantirna
Recruitment hospital [2] 29025 0
Peter James Centre - Forest Hill
Recruitment postcode(s) [1] 45304 0
3152 - Wantirna
Recruitment postcode(s) [2] 45305 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 320806 0
Government body
Name [1] 320806 0
Eastern Health
Country [1] 320806 0
Australia
Funding source category [2] 320908 0
University
Name [2] 320908 0
La Trobe University
Country [2] 320908 0
Australia
Primary sponsor type
Government body
Name
Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 323458 0
University
Name [1] 323458 0
La Trobe University
Address [1] 323458 0
Country [1] 323458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319327 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 319327 0
Ethics committee country [1] 319327 0
Australia
Date submitted for ethics approval [1] 319327 0
19/11/2025
Approval date [1] 319327 0
09/12/2025
Ethics approval number [1] 319327 0
LR25-093-124139
Ethics committee name [2] 319339 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 319339 0
Ethics committee country [2] 319339 0
Australia
Date submitted for ethics approval [2] 319339 0
10/12/2025
Approval date [2] 319339 0
10/12/2025
Ethics approval number [2] 319339 0
LR25-093-124139

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

Contacts
Principal investigator
Name 146994 0
Ms Melanie Haley
Address 146994 0
Allied Health Clinical Research Office, Level 2, 5 Arnold Street, Box Hill 3128
Country 146994 0
Australia
Phone 146994 0
+61412187353
Fax 146994 0
Email 146994 0
[email protected]
Contact person for public queries
Name 146995 0
Melanie Haley
Address 146995 0
Allied Health Clinical Research Office, Level 2, 5 Arnold Street, Box Hill 3128
Country 146995 0
Australia
Phone 146995 0
+61412187353
Fax 146995 0
Email 146995 0
[email protected]
Contact person for scientific queries
Name 146996 0
Melanie Haley
Address 146996 0
Allied Health Clinical Research Office, Level 2, 5 Arnold Street, Box Hill 3128
Country 146996 0
Australia
Phone 146996 0
+61412187353
Fax 146996 0
Email 146996 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: La Trobe University institutional repository: OPAL

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.