Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001238662
Ethics application status
Approved
Date submitted
5/10/2023
Date registered
30/11/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and preliminary efficacy of a Hospital Fall Prevention Moments of Care intervention: a pilot trial
Scientific title
Feasibility and preliminary efficacy of a Hospital Fall Prevention Moments of Care intervention: a pilot trial
Secondary ID [1] 310733 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 331675 0
Immobility 331676 0
Health literacy 331677 0
Condition category
Condition code
Injuries and Accidents 328404 328404 0 0
Fractures
Physical Medicine / Rehabilitation 328405 328405 0 0
Physiotherapy
Public Health 328406 328406 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Falls Prevention Moments of Care is a pragmatic intervention that centers around hospital caregiver and patient engagement. It consists of two intervention parts A and B, which will be co-produced then delivered by existing hospital caregivers, and evaluated during the pilot trial.

Eligible caregivers are nursing and allied health staff employed by SJGHC on study wards who engage with patients during moments of care when the intervention will be delivered. All patients are eligible to receive interventions and delivery occurs according to time-points. Depending on when potential patients are admitted to study wards, will determine if they receive control condition or intervention A alone or in combination with intervention B. The order of which study ward cluster will commence the trial will be determined randomly using sealed opaque envelopes that are opened immediately prior to commencement of a successive cluster ward allocation to receive the interventions. All clusters will commence in control condition for 4 weeks. Caregivers on study wards will then receive training to deliver intervention A before crossing over to intervention delivery for 4 weeks. At the conclusion of the 4-week intervention A intervention delivery, caregivers will then receive training to deliver intervention B, which would be delivered concurrently with intervention A for another 4-weeks. Randomisation of the 4 cluster wards to commence the trial are separated by 2 week intervals. Follow-up data collection occurs for 4 weeks after the cluster has been exposed to the intervention subsets (control, intervention A, intervention A + B). The trial duration is 26 weeks. A further 16 weeks of study duration has been allocated to enable data analysis, reporting, and publication of findings.

The objective of the inter-professional caregiver training is to enhance fidelity of intervention implementation during the trial. This will be facilitated by building i) caregiver knowledge, attitude, and skills to identify patient falls risks and utilize clinical reasoning to plan and implement the falls prevention interventions; and ii) nurture a positive culture for inter-professional collaboration towards implementation of falls interventions. Lessons learned from an inter-professional education evaluation by Shaw and colleagues (2022) were drawn into this study’s caregiver training development, in particular by utilizing the 4P model of educational design (Kiegaldie, 2021). During pre-trial, ten clinical educators will be convened for 1-hour on three occasions over a period of 12 weeks to work together as an interdisciplinary group and co-produce the education plan, intervention scripts, and timetable for the 1-hour caregiver training sessions to be provided prior to intervention delivery on each cluster/ study ward. The clinical educators are nursing and allied health staff employed by SJGHC, some have postgraduate qualifications, and all have experience in their roles as clinical educators at the hospital site.

Once the trial commences, clinical educators will be rostered to provide training for caregivers during 2-weeks prior to commencement of intervention phases on the four cluster wards. There will be 2 clinical educators rostered to attend per session. Education sessions will be 1-hour in duration rostered to occur during the last 1 hour of a caregiver’s allocated shift. There are expected to be 8 caregivers per session, and a total of approximately 50 caregivers who will require training on each cluster ward prior to intervention phases. There will be a separate 1-hour education session for each intervention A and B. Sessions will be delivered face to face in the hospital conference room and simulation ward bedrooms. Study ward caregiver education content will include:
1) information about minimum falls prevention interventions in the hospital Falls Risk Assessment and Management Plan (FRAMP-CI) and cognitive assessments (4AT) and integrating clinical reasoning to implement targeted patient falls education (intervention A), and supervised mobilization (intervention B) during moments of care.
2) Intervention scripts provided to caregivers who will then practice use with simulated patient cases. The scripts promote patient engagement by opening the conversation during the admission moment of care about the problem of falls in hospital when mobilizing around the room and bathroom, and showing patients how to be safe when mobilizing in their room, including use of a walking aid and the patient’s own footwear. The script invites patients to be involved in their own falls prevention, to be empowered to call for assistance, and to keep in check with how they are feeling about their ability and move safely off the bed and chair throughout the day. Reinforced messaging and opportunity to engage with patients will occur during the handover moment of care, and any change required to support the falls prevention care plan agreed between the patient and the caregiver during that shift. For patients who have diverse needs, such as diagnosis of dementia or delirium, additional strategies are discussed during the education, including prompting to use clinical reasoning and existing best practice care.

Clinical educator teaching methods include demonstrating delivering the intervention to the patient, including from diverse cultural and linguistic backgrounds and those with impaired cognition due to delirium, impaired hearing, and vision. Interactive teaching strategies will be employed to develop clinical reasoning, critical thinking, and educating others into daily clinical practice (Von Colln-Appling & Giuliano, 2017). For example, by utilizing problem-based learning, in-situ simulation, real-life case-studies and group discussions; reflective thinking, and trouble-shooting potential barriers to implementation amongst their peers.

Intervention A: Moments of Care Falls Education was developed as a novel, theory-driven, tailored intervention that aims to address the gaps in clinical applicability of existing fall prevention evidence in the contexts of variable clinical practices and variable individual caregiver and patient attitudes and behaviors, but be feasible for delivery by existing caregivers (i.e., without additional staff). The intervention that will be delivered by caregivers is developed using the Behavior Change Wheel (BCW) framework based on the Capability-Opportunity-Motivation-Behavior (COM-B) model, which suggests that behavior change is enabled by modifying a patient’s capability, opportunity, and motivation to engage in the target behavior (Michie, 2011). The intervention will be delivered to patients by nursing or allied health caregivers who have been trained to deliver the intervention. This education is delivered at the patients’ hospital bedside on admission day 0 and whenever the patient moves to another room or ward. Patient education will be reinforced at regular bedside handover, which are moments of care completed by nursing caregivers during shift changes at 0700, 1300, 1430; 1900, and 2100. This occurs between up to four nursing caregivers and potentially the allied health caregivers who stand in the patient’s room. They are encouraged to engage and check-in with the patient during handover to gain their subjective perspective of how they are recovering, if there have been any changes in their condition, and if their confidence in their mobility is the same as when the care board was last updated. Engagement and education provided during handovers will be documented by caregivers in patients’ paper-based progress notes.

Intervention B: Education to promote daily mobilization of patients will be provided by a nursing or allied health caregiver including overseen by ward physiotherapist per shift for patients who are medically safe to mobilize independently with or without a walking aid. Collaboration between caregivers across disciplines will be encouraged through caregiver training prior to the intervention phase. The goal is to promote patient mobility during hospitalization. As outlined in caregiver training prior to intervention commencement, caregivers will document completion of Intervention B in patients’ bedside hospital Falls Risk Assessment and Management Plan (FRAMP-CI) using dated free text in the ‘individualized interventions for falls prevention and delirium management’ section, and in patients’ paper based progress notes.
Intervention code [1] 327148 0
Behaviour
Comparator / control treatment
All patients who are located on study wards will receive usual care as control during the initial control periods. In this regard ‘usual care’ includes many aspects that are designed to achieve high-quality care, including prevention of falls and is expected to meet all requirements for accreditation against standards specified by the Australian Commission on Safety and Quality in Healthcare. Usual care consists of nursing caregivers completing an assessment of patients’ falls risk upon admission to the ward, which is repeated if the patient moves to another ward, has a fall, or has a change in medical condition or change in cognition as can occur with development of delirium. The individual patient assessment is completed using the hospital Falls Risk Screening Tool (FRAMP-CI), which has integrated two separate validated tools, the Peninsula Health Falls Risk Assessment Tool (Haines et al., 2006) and the 4AT (Anand et al., 2019). Following assessment, interventions are recommended as a part of the action plan that are documented in the FRAMP-CI that remains at the patient bedside, and incorporated into daily comprehensive care plans. Action plans address patient falls risk factors such as ensuring adequate fluid intake, access to walking aids, footwear and sensory aids, and promoting sitting out of bed. Environmental risk factors are also addressed on the FRAMP-CI, including ensuring adequate room lighting, and removal of obstacles. Orientation of patient to the room and bathroom and promotion of sitting out of bed as much as possible are included in the FRAMP-CI as minimum intervention for falls and delirium risk factors. Mobilization can occur, but targeted daily mobilization is not a component of usual care.
Control group
Active

Outcomes
Primary outcome [1] 336264 0
Caregiver acceptability of the co-produced education for intervention A and B
Timepoint [1] 336264 0
Immediately following caregiver education delivery, prior to intervention phase and following informed consent of the caregiver receiving the education
Primary outcome [2] 336265 0
Fidelity of Intervention A and B delivery and integration into moments of care at cluster level
Timepoint [2] 336265 0
on a weekly basis throughout the trial.
Primary outcome [3] 336266 0
Patient knowledge and attitude towards falls prevention for a purposive sample following written informed consent of the patient participant receiving control or falls prevention intervention A, or A combined with B.
Timepoint [3] 336266 0
The PI will approach patient participants at the bedside to gain written informed consent, prior to survey completion. The time-point for survey completion will be when patient participants are receiving care on study wards during either control or intervention phases. If the patient participant is agreeable, surveys may be recorded in order to gain perspectives in their real voice. The survey is not delivered as a pre-post survey, but as a single survey per participant.
Secondary outcome [1] 427617 0
Number of falls on study wards / clusters
Timepoint [1] 427617 0
At baseline prior to trial commencement and at follow-up after both interventions have been delivered on study wards
Secondary outcome [2] 428276 0
Falls injuries on study wards / clusters
Timepoint [2] 428276 0
At baseline prior to trial commencement and at follow-up after both interventions have been delivered on study wards
Secondary outcome [3] 428277 0
Number of patients who fall on study wards / clusters
Timepoint [3] 428277 0
At baseline prior to trial commencement and at follow-up after both interventions have been delivered on study wards
Secondary outcome [4] 428278 0
Characteristics of fall events
Timepoint [4] 428278 0
At baseline prior to trial commencement and at follow-up after both interventions have been delivered on study wards
Secondary outcome [5] 428279 0
length of stay of people who fall
Timepoint [5] 428279 0
At baseline prior to trial commencement and at follow-up after both interventions have been delivered on study wards
Secondary outcome [6] 428280 0
discharge destination
Timepoint [6] 428280 0
At baseline prior to trial commencement and at follow-up after both interventions have been delivered on study wards
Secondary outcome [7] 428281 0
30-day mortality (censored at hospital discharge)
Timepoint [7] 428281 0
30 days from hospital discharge
Secondary outcome [8] 428282 0
6-month readmissions to study hospital
Timepoint [8] 428282 0
6-months from hospital discharge

Eligibility
Key inclusion criteria
There are two ‘levels’ of participation:
1. Approximately 200 study ward caregivers responsible for providing patient care on study wards who will receive training to deliver the interventions prior to commencement. Eligible caregivers are nursing and allied health staff employed by SJGMPPH on study wards who engage with patients during moments of care when the intervention will be delivered. There are approximately 50 caregivers who work on each of the four study wards, rather than moving across different wards, including with permanent or casual SJGMPPH employment contracts. A purposive sample of these study ward caregivers will undertake a qualitative survey during follow-up to gather primary feasibility outcomes, and this will occur following written informed consent.
2. Patients who are admitted to study wards and may include people who are highly dependent on medical care or people with a cognitive impairment, an intellectual disability, or a mental illness. Patient state of alertness and cognition will be measured using the 4AT score (Anand et al., 2019), which is a validated cognitive screen already in use at the hospital as a part of usual care. Participants who are assessed as having possible cognitive impairment (4AT score between 1 and 3), or possible delirium and cognitive impairment (score of 4 or more), will continue to be included, and caregiver training will guide intervention delivery. A purposive sample of these patients will undertake a semi-structured survey during control and intervention delivery to determine feasibility outcomes, and this will occur following written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The stepped-wedge cluster design will be conducted with uni-directional cross-over from control to intervention phase with the unity of randomization being the time that the cluster crosses over to receive an intervention subset.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a feasibility study and the data will inform sample size calculation for a future stepped-wedge or cluster RCT designed to have sufficient statistical power to detect treatment effects that are of a plausible size. This study will determine the target sample size, number of clusters, and cluster duration sufficient to provide an accurate estimate of the effectiveness and safety of the interventions. It is intended that this trial would occur at other SJGHC hospital sites. It should be noted that this pilot study is not powered to detected statistically significant changes in the measures of effectiveness of reducing incidence of falls and length of stay.

Data for the feasibility components of the study will be analyzed using descriptive statistics (mean, standard deviation and percentages), proportion of patients admitted who received the interventions, and counts and proportions of observed moments of care corresponding to the intervention components. Evaluation of difference in the delivery of interventions will be evaluated by comparison of proportions using Chi-squared method and comparison of means or medians using appropriate parametric or non-parametric tests, depending on distribution of data. This analysis will not take into account the effect of clustering.

A preliminary evaluation of the effect of the interventions on the incidence of falls and the proportion of patients who fall will be conducted using methods that comply with recent CONSORT extension statement for stepped wedge trials (Hemming et al., 2018). Analysis of both the incidence of falls and proportions of patients who fall will be performed using generalized estimating equations that account for clustering, using the R package. Design characteristics of a future cluster trial are intended to use Bayesian, rather than frequentist methods, and are beyond that which is necessary to specify in this protocol.

To determine effectiveness on behavior change elements, data will be analyzed using generalized linear mixed models to compare differences within and between groups over time (pre/post). A post-hoc analysis will be completed using the group differences to determine the required sample size for a future adequately powered study using these outcomes. All statistical analyses will be conducted using Stata v17 (StataCorp, College Station, TX). Interview transcripts and observational data such as field notes will be analyzed using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
15/02/2024
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
10000
Accrual to date
20000
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25702 0
St John of God Hospital, Midland - Midland
Recruitment postcode(s) [1] 41526 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 314958 0
Hospital
Name [1] 314958 0
St John of God Midland Public and Private Hospital
Country [1] 314958 0
Australia
Primary sponsor type
Hospital
Name
St John of God Midland Public and Private Hospital
Address
1 Clayton Rd, Midland WA 6056
Country
Australia
Secondary sponsor category [1] 316974 0
None
Name [1] 316974 0
Address [1] 316974 0
Country [1] 316974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313937 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 313937 0
PO Box 5753, ST Georges Tce, Perth WA 6831
Ethics committee country [1] 313937 0
Australia
Date submitted for ethics approval [1] 313937 0
02/11/2023
Approval date [1] 313937 0
14/02/2024
Ethics approval number [1] 313937 0

Summary
Brief summary
St John of God Health Care (SJGHC) want to develop an innovative solution to prevent falls at Midland hospital as a model for other hospital sites. The incidence of falls is influenced by the complexity of the ward environment and patient characteristics such as age and cognitive status. A common theme of falls that occur in hospital is that many patients do not accurately identify their risk of falling. Studies have identified unwillingness of patients to ask for assistance when mobilizing in hospital, often because they don’t want to be a burden to caregivers. As such, communication between patients and caregivers is a potentially modifiable factor that influences the ‘risk-taking’ behavior of inpatients. Another factor that may be contributing to the risk of falls during the hospital admission, as well as after discharge is that the prevention of falls may have created a disincentive to mobilize patients. Immobility, imposed to prevent falls, may, itself, be an important contributor to falls and subsequent disability. Individualized patient education is an important strategy for falls prevention and will be implemented during the trial to understand what works best for patients and caregivers at Midland hospital. We will use the admission moment of care to engage with the patient and their family and demonstrate how to safely mobilize around their room and take action to prevent their own falls. An additional intervention will address the daily mobilization of inpatients. The first phase will co-design interdisciplinary caregiver training for effective delivery of patient focused falls education during the trial. This project is motivated by the need to impact hospital falls prevention and to understand if the caregiver training and patient education is feasible for consideration in a larger trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129850 0
Dr Chiara Naseri
Address 129850 0
St John of God Midland Public and Private Hospital, 1 Clayton St, Midland WA 6056
Country 129850 0
Australia
Phone 129850 0
+61 089462 4138
Fax 129850 0
Email 129850 0
chiara.naseri@sjog.org.au
Contact person for public queries
Name 129851 0
Dr Chiara Naseri
Address 129851 0
St John of God Midland Public and Private Hospital, 1 Clayton St, Midland WA 6056
Country 129851 0
Australia
Phone 129851 0
+61 089462 4138
Fax 129851 0
Email 129851 0
chiara.naseri@sjog.org.au
Contact person for scientific queries
Name 129852 0
Dr Chiara Naseri
Address 129852 0
St John of God Midland Public and Private Hospital, 1 Clayton St, Midland WA 6056
Country 129852 0
Australia
Phone 129852 0
+61 089462 4138
Fax 129852 0
Email 129852 0
chiara.naseri@sjog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In line with the National Health and Medical Research Council's Open Access Policy, de-identified data and underlying published results will be made available.
When will data be available (start and end dates)?
At the time of publication as per open access guidelines and available for 5 years after publication (December 2024 - December 2029).
Available to whom?
De-identified database may be made available upon request to the PI with evidence that the requesting researcher has complied with ethics requirements in maintaining privacy of data, and the data request is consistent with the aims of their approved proposal.
Available for what types of analyses?
Only to achieve the aims of the approved proposal
How or where can data be obtained?
Access subject to approvals by the Principal Investigator Dr Chiara Naseri (chiara.naseri@sjog.org.au)


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.