Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001469505p
Ethics application status
Submitted, not yet approved
Date submitted
14/11/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safe Recovery to Prevent Hospital Falls.
Scientific title
Evaluating the effectiveness of implementing a falls prevention patient education program (the Safe Recovery Program) led by falls champions in addition to usual care on falls rates in hospitals
Secondary ID [1] 313367 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital falls 335722 0
Fall-related injuries 335723 0
Condition category
Condition code
Injuries and Accidents 332288 332288 0 0
Fractures
Injuries and Accidents 332289 332289 0 0
Other injuries and accidents
Public Health 332419 332419 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An individualised patient fall prevention program is provided to eligible patients in the participating wards in addition to usual hospital care, alongside staff training. Patient component including being provided with a brochure or booklet designed specifically for the study and watching a video of either 3 or 8 minutes, tailored for ward and patient availability . Tailoring occurs with pre-post discussion approximately 5 to 10 minutes with patient to identify personally relevant messages and develop brief plan to manage their falls risk. Messages focus on tailored needs including seeking help from staff, using walking aids, discussing toileting needs. Brochure left with patient to review as desired and video reshown as desired. Initial intervention is provided by Allied Health Assistant aiming to provide within 48 hours of admission, supervised by Allied Health staff. Patient knowledge is evaluated by ongoing discussion and by questionnaire pre post sessions.

The education is reinforced by ward staff. Ward staff training is led by trained allied health and nursing falls champions. The education program is integrated with existing ward falls prevention management, also coordinated by the ward staff and falls champions. Falls champions and allied health receive initial training programs of between 1 and 4 hours and ward staff receive ongoing short training (approximately 15 to 20 minutes online and/ or on ward according to availability and staff rotations with aims for all staff to recieve at least one session of training. Champions and Allied health assistants receive training in the 2 months prior to commencement.

Wards enter the intervention at 5 week periods over the time of the trial (70 weeks) therefore some wards have a longer exposure to the intervention

Usual care involves falls risk assessment and treatment provided by ward staff from time of admission and as part of patients medical care and their multidisciplinary care, Hospital wide falls policies and practice and 24 hour care of patients. Staff at all hospitals follow mandated policies and guidelines for falls prevention and post fall care and patients are provided with falls prevention education in patient orientation materials and by staff throughout admission. In intervention wards patients will additionally be seen by the Allied Health Assistant and be provided with the video and booklet and have this education re-inforced by staff will receive specific training that assists them to respond to the patient to help them to meet their actions (e.g. asking for help) that are directed by the messaging.
Intervention code [1] 329946 0
Prevention
Comparator / control treatment
Usual care, which includes individualised falls risk management for all patients on participating wards and organisation wide safety and quality programs.
Control group
Active

Outcomes
Primary outcome [1] 339860 0
Rates of falls
Timepoint [1] 339860 0
Baseline and 70 weeks after baseline.
Secondary outcome [1] 441673 0
Fall injury rates
Timepoint [1] 441673 0
Baseline and 70 weeks after baseline
Secondary outcome [2] 441675 0
Patient and staff falls awareness, knowledge, and engagement in falls prevention. Assessed as a composite outcome, using custom designed surveys.
Timepoint [2] 441675 0
Staff and patients will be assessed at pre and post first training engagement. Staff surveyed separately also between 5 and 10 weeks after the intervention commences on their wards.
Secondary outcome [3] 441676 0
Economic benefit
Timepoint [3] 441676 0
End of trial

Eligibility
Key inclusion criteria
a) Ward level (effectiveness outcomes)
Wards for the trial will be medical, acute care wards, with some rehabilitation or surgical wards and enrol large numbers of older adults. Patients will be screened by their team to be medically stable to receive the patient component of the education.

b) Individual level (implementation outcomes)
Patients who are receiving care on participating wards and/ or their family will be eligible for inclusion. Patients who do not speak English will be included for consideration for interview if their family are present on the ward.

Staff who work on participating wards from the multidisciplinary team.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Ward level (effectiveness outcomes)
Wards that provide care for children <18 years, ante or post-natal services, intensive care or high dependency units or emergency departments will be excluded from consideration. These wards have a different context for falls events and therefore tailored strategies are required. Surgical units may be included if the patient population includes large numbers of older adults admitted and if the length of stay is greater than 48 hours. Short stay or ambulatory units are not included as they also have differing requirements for falls prevention programs.
Any patients who are deemed too unwell, or unable to be approached for other reasons (e.g. infection control, acute confusion) will be excluded by ward staff at the time of patient component of education delivery. However relevant staff interventions, such as noting strategies in the care plan and speaking to families, continue across the wards for all patients, regardless of which patients are personally shown the education.

b) Individual level (implementation outcomes)
Staff who have not worked on participating wards for at least six weeks will be excluded from participation as they will have limited knowledge and experience of the intervention. Patients who are not able to provide written informed consent, due to having a cognitive impairment diagnosed by the medical team will be excluded. Where patients have diagnosed dementia or acute confusion, their family members will be asked to participate in an interview to seek their reflections on the patient’s experience on the ward.

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)
Codes for each ward will be created by a CI not involved in any site or intervention delivery and used to allow for blinded randomisation of the 12 wards. The randomisation will occur before the start of the trial using a computer-generated number sequence by an independent third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will occur using a computer-generated number sequence by an independent third party. Wards will be randomised in pairs from one site, with further randomisation to split the pair into first or second position.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A stepped wedge cluster randomized controlled trial each ward enters at 5 week intervals.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
a) Ward level (effectiveness outcomes)
Fall rates and injury rates, will be compared using generalised linear mixed models following best practice stepped-wedge cRCT model specification. This includes a random cluster effect and random cluster by step effect. Each step period will be modelled as a fixed categorical effect to account for potential secular trends. The effect variable will switch from 0 to 1 as each cluster changes from control to intervention steps. Results for unadjusted (except clustering) and adjusted (by potential confounders) will be reported. Sensitivity analysis will consider a potential linear intervention effect to account for increasing familiarity with the intervention.

b) Individual level (implementation outcomes)
Quantitative data. Intervention delivery measured from research records, including proportion of patients who receive education, number of patient and staff training sessions, vCoP use, and associated surveys, will be summarized using descriptive statistics, then analyzed as appropriate to evaluate implementation fidelity, changes in awareness, knowledge and engagement in fall preventive strategies. Qualitative data. Data from interviews and open ended questions from surveys will be analyzed using inductive analysis. Themes will be developed inductively, based on the data itself, or deductively, informed by the guiding theoretical framework (Consoldiated Framework for Implementation Research (CFIR). Multiple researchers will review and discuss themes to enhance rigor, minimize bias, and ensure that interpretations are grounded in participants' experiences. NVivo software will be used to assist with coding and organizing the data systematically. All data will be de-identified to protect participant confidentiality. Findings from all datasets will be merged as a matrix to compare ward, hospital and organization level implementation barriers and enablers to success using the CFIR framework.

c) Economic evaluation
Cost-effectiveness analysis (CE) will estimate the incremental cost (healthcare system perspective) of implementing the intervention per fall averted. This will include trial-related-intervention resource use (e.g., staff training, delivering Safe Recovery program) and other healthcare use associated with usual care including post-fall care. We will record data, analyze and report findings following guidelines for trial-based CE analyses, incl. reporting resource use and costs (and valuation methods) for intervention & control conditions. Trial-based incremental CE ratio (ICER) will = [(CostIntervention) - (CostControl)] / [(EffectIntervention- EffectControl)]. Due to the potential for uncertainty and non-normal distributions, 95%CIs (costs & effect estimates) and 95% confidence ellipses (CE plane) will be derived from bootstrap resampling. CE acceptability curves will be prepared for a range of potential CE thresholds. To ensure findings are policy-ready, we will probabilistically model costs & effects of ongoing implementation from the perspective of hospitals with low, medium & high fall rates, including staff turnover & re-training (stochastic extrapolation modelling using following practice modelling guidelines) over 1, 5 and 10-yr time horizons. We will assess sensitivity of results to variation in measured resource use, effectiveness, discounting and unit costs (1-way and multi-way sensitivity analyses, in addition to probabilistic sensitivity analysis).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
3/07/2026
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 317806 0
Government body
Name [1] 317806 0
Department of Health and Aged Care - Medical Research Future Fund
Country [1] 317806 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 320137 0
None
Name [1] 320137 0
Address [1] 320137 0
Country [1] 320137 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316489 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316489 0
Ethics committee country [1] 316489 0
Australia
Date submitted for ethics approval [1] 316489 0
25/11/2024
Approval date [1] 316489 0
Ethics approval number [1] 316489 0

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

Contacts
Principal investigator
Name 138062 0
Prof Anne-Marie Hill
Address 138062 0
School of Allied Health UWA, 35 Stirling Hwy Crawley WA 6009
Country 138062 0
Australia
Phone 138062 0
+61400737570
Fax 138062 0
Email 138062 0
anne-marie.hill@uwa.edu.au
Contact person for public queries
Name 138063 0
Anne-Marie Hill
Address 138063 0
School of Allied Health UWA, 35 Stirling Hwy Crawley WA 6009
Country 138063 0
Australia
Phone 138063 0
+61400737570
Fax 138063 0
Email 138063 0
anne-marie.hill@uwa.edu.au
Contact person for scientific queries
Name 138064 0
Anne-Marie Hill
Address 138064 0
School of Allied Health UWA, 35 Stirling Hwy Crawley WA 6009
Country 138064 0
Australia
Phone 138064 0
+61400737570
Fax 138064 0
Email 138064 0
anne-marie.hill@uwa.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
Confidential hospital patient data.

Note: The study protocol is planned to be published as a paper in a journal


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.