Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12624001233516p
Ethics application status
Not yet submitted
Date submitted
18/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Date results provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Care Check (3Cs) for Prevention of Falls in Patients with Cognitive Impairment
Scientific title
Co-designed Caregiver Education for Prevention of Falls in Patients with Cognitive Impairment: a realist implementation, feasibility and preliminary effectiveness pilot study
Secondary ID [1] 312980 0
Nil known
Universal Trial Number (UTN)
Trial acronym
3Cs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 335162 0
Hospital Falls risk
 335163 0
Delirium 335164 0
Cognitive risk 335165 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331658 331658 0 0
Other physical medicine / rehabilitation
Neurological 331659 331659 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Care Check is a pragmatic caregiver education intervention that promotes proactive engagement between hospital caregivers and patients and their family. The caregiver education intervention will be co-designed by the research team, patient and family representatives, and hospital caregivers, making the education novel and relevant to the study wards at SJGMPPH. The intention of the caregiver education is to optimize the use of the existing Falls Risk Assessment and Management plus cognitive impairment tool (FRAMP-CI) by caregivers to determine feasibility and hospital caregiver practice change and the extent to which late-phase trial might be possible in the future to inform adoption into practice or policy (ACTA, 2019). The GUIDED logic model was utilized for reporting intervention development (O’Cathain, Croot, Duncan et al, 2019). The education intervention is described using the TIDier checklist (Hoffman et al., 2014). The question we are aiming to answer through the co-design process are how can existing FRAMP-CI tool for falls and cognitive risk screening, assessment, and management be regularly used by the multidisciplinary team to promptly identify patients with deteriorating cognitive state, and how can existing workflows be enhanced to support the patient with identified cognitive impairment? Caregiver participants and the researcher PI Naseri will purposefully engage in critical reflection during education sessions to understand real-life situations in the caregivers' workplace, and create solutions by applying their experience-based knowledge to change practice (Greenhalgh et al., 2019). This is also consistent with the objectives of Experience-Based Co-Design approach (Donetto et al., 2015; Ramos et al., 2020), as caregivers and researchers will participate during semi-structured interviews and satisfaction surveys to detail their experience to understand the feasibility (acceptability and adoption) of the caregiver education program and the strategies recommended through the education (Manafo et al., 2018). To operationalise the co-design approaches that focuses on caregivers and patients as end-users, the Generative Framework for Healthcare Innovation was applied to this study’s methodology, including the three major stages of pre-design, co-design, and post-design as conceptualised by Bird et al (2021).

The education intervention aims to enhance falls and cognitive care practice by multidisciplinary caregivers (nursing, allied health, medical officers) on study wards through using the existing FRAMP-CI tool during existing moments of care, such as admission and bedside handovers to screen all patients admitted to study wards and re-screening to proactively detect and manage falls and cognitive risk and decline, and personalize care through family and multidisciplinary engagement. The FRAMP-CI provides minimal and individualized interventions as a guide for caregiver clinical decision making, including prompting for multidisciplinary referrals and use of Top 5, which is a validated communication tool designed to enhance personalized care (Clinical Excellence Commission, 2015).

The 4-P model of education intervention design was utilized to draft the education intervention (Kiegaldie, 2021). This considers context of caregiver learners (presage), engagement with caregiver stakeholders to produce the education resource (planning), education content (process), and how the impact of the education will be evaluated (product).

The co-design component of the intervention commences by convening a stakeholder group of approximately 10 members for 1-hour on three occasions over a period of 2 months to work together as an interdisciplinary group and co-produce the education content and timetable for the 1-hour caregiver training sessions. The stakeholder group consist of nursing, allied health, and medical caregivers employed by SJGMPPH who have experience of working on study wards, including the Nurse Unit Managers, Physicians, Geriatricians, Clinical Educators, and Jan O-Shea a patient consumer representative and member of SJGMPPH Consumer Advisory Council, Convenor of Swan Dementia Café, a retired clinical nurse, who has lived experience as a carer for a person living with dementia. An honorarium of $50 per hour has been allocated in the budget to reimburse Jan O’Shea for her time to attend 3x 1 hour stakeholder meetings.

During pre-design during March-April 2025, education content that will be presented to the stakeholder group is a novel theory-driven, tailored education that aims to address 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, that is without additional staff. To address the complexity of the intervention, the education 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 person’s capability, opportunity, and motivation to engage in the target behavior (Michie, 2011). Co-design also considers the context of the ward, gaps identified in meeting target falls prevention guidelines and dementia and delirium care, existing documentation tools, moments of care, and availability of senior caregivers to support peer learning.

During co-design, implementation, and refinement phase that occurs for 6 months during May-October 2025, caregiver participants (N=approx.200) will attend the education session and receive a soft copy of the study poster. PI Naseri will deliver face to face education to caregiver participants during 60 minute sessions in training rooms on the study wards, this includes time for participants to complete the semi-structured evaluation survey. Survey feedback received from caregivers will be used to guide co-design of education content to enrich the feasibility and preliminary effectiveness on caregiver practice change and also on falls rates on study wards. Additional training support will be provided to caregiver participants on study wards by PI Naseri during implementation. 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). The iterative education implementation and evaluation across the wards with continuous collection of staff behavior change elements (capability, opportunity, motivation), and practice change observed through documentation audits will guide refinement of education content. Findings will be presented to the stakeholder group following the first and second cycle of education to enable collaboration on co-design of education content, so that by the end of the third cycle, the education will be optimized for the context in which it will be implemented. Lessons learned from an inter-professional education evaluation by Shaw and colleagues (2022) were drawn into this study’s caregiver education development, which also utilized the 4P model of educational design.

Study ward caregiver education content will include: 1) Information about minimum falls prevention interventions in the hospital Falls Risk Screening Tool and cognitive assessments (4AT) and integrating clinical reasoning to implement targeted patient falls and cognitive care interventions as signposted in the FRAMP-CI ; 2) Co-designed Intervention scripts refined by caregivers following practice use with simulated patient cases, such as Patient Mary who independently mobilizes but is now feeling unsteady and uncertain of where she is; and Patient Bob who had frequent falls leading up to hospital admission and requires assistance to mobilize and to feel assured but is not sure how to ask for assistance. 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 and their family caregivers to be involved in their falls prevention and for family to feel empowered to be a part of their loved one’s care at different times of the day to enable the patient to feel assured and orientated to their care, such as by sharing a meal with the patient, or attending therapy sessions. Reinforced messaging and opportunity to engage with patients and family caregivers will occur during the bedside 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 cognitive impairment risks as identified by the FRAMP-CI and 4AT, the tool outlines possible minimal interventions to be delivered and discussed with the patient and their family caregivers, including prompting to use Top5 communication tools and Sunflower room poster, with opportunity for review of action plans.

To evaluate the final Product of the education, caregiver acceptability will be measured using semi-structured surveys immediately following training sessions and the PI will conduct documentation audits during the trial to ensure fidelity of intervention delivery. A summary of the education program shows how the Kilpatrick (2016) levels and COM-B (Michie et al., 2011) models will be addressed during education co-design, implementation, and evaluation.

During post-design analysis that will occur for 2 months during November - December 2025, new evidence about the feasibility of education from perspective of caregivers, patients and family based on their satisfaction with their care, and falls efficacy, will be incorporated into translation requirements and action items to close the loop in supporting evidenced-based practice change and quality care that would be promoted through final reporting and dissemination during the subsequent 6-months.
Intervention code [1] 329518 0
Early detection / Screening
Intervention code [2] 329519 0
Treatment: Other
Intervention code [3] 329520 0
Prevention
Comparator / control treatment
Although there is no control condition for this non-randomized cohort study, a historical comparator will enable effectiveness of the co-designed education intervention on falls rates during the planned 6-month intervention period during May-October 2025, and 2-month follow-up during November - December 2025. The historical comparator will be falls rates on study wards at St John of God Midland Private and Public hospital during May - December 2024, gathered using existing hospital incident reporting methods (Riskman reporting). It should be noted that this pilot study is not powered to detected statistically significant changes in the measures of effectiveness in reducing the incidence of falls.
Control group
Historical

Outcomes
Primary outcome [1] 339394 0
Feasibility: Caregiver acceptability of the co-designed education
Timepoint [1] 339394 0
Immediately following caregiver education delivery
Primary outcome [2] 339396 0
Feasibility: Caregiver behavior change: prompt identification of patients with cognitive impairment by study ward caregivers, implementation of minimum interventions, and re-assessment
Timepoint [2] 339396 0
Baseline 2 months during March-April 2025, during 6-month implementation and refinement phase May-October 2025, and 2-month follow up November-December 2025.
Primary outcome [3] 339397 0
Feasibility: Expense for hospital to deliver x1 hour education sessions to caregivers
Timepoint [3] 339397 0
During 2-month follow-up period November - December 2025.
Secondary outcome [1] 439765 0
Preliminary Effectiveness: Falls rates
Timepoint [1] 439765 0
Historical comparator : May-December 2024; and during 6-month implementation and refinement phase May-October 2025, and 2-month follow up November-December 2025.
Secondary outcome [2] 439771 0
Patient and family satisfaction with their care
Timepoint [2] 439771 0
Baseline 2 months during March-April 2025, during 6-month implementation and refinement phase May-October 2025, and 2-month follow up November-December 2025.

Eligibility
Key inclusion criteria
Key inclusion criteria: there are two levels of participation:
1. Hospital caregivers: approximately 200 caregivers responsible for providing patient care on study wards who will receive the co-designed education intervention. Eligible caregivers are nursing, allied health, and medical caregivers employed by SJGHC on study wards who engage with patients during moments of care when the falls and cognitive care strategies promoted during the education sessions will be delivered to patients on study wards. There are approximately 100 caregivers who work on each study ward who have permanent or casual SJGHC employment contracts.
2. Patients who are admitted to study wards who may receive care from nursing, allied health and medical caregiver participants during 6-month implementation phase (N approx. 10,000 ) and may include people who are highly dependent on medical care or people with a cognitive impairment, an intellectual disability, or a mental illness. The study wards only admit adults from the age of 18 and over. Patients who speak English as a second language will be invited to use an interpreter to assist them to engage with the interventions in addition to a family member. The patient’s projected length of stay will not affect inclusion in the trial, as all eligible patients may receive the falls and cognitive care strategies promoted during the education from day of admission. If a patient is moved from an intervention to another ward they will no longer receive the interventions, but will be analyzed on an intention-to-treat basis. Patient state of alertness and cognition will be measured using the 4AT score (Bellelli et al., 2014), 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. A purposive sample of these patients (n= 10 per study ward at baseline and follow-up) and if appropriate, their family caregivers will undertake an anonymous net promotor score survey, which is an existing evaluation method used by the hospital, for which patients and family consent to completing to inform quality improvement.
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
Educational / counselling / training
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
Other
Other design features
Although there is no control condition for this non-randomized cohort study, a historical comparator will enable effectiveness of the co-designed education intervention on falls rates during the planned 6-month intervention period during May-October 2025, and 2-month follow-up during November - December 2025. The historical comparator will be falls rates on study wards at St John of God Midland Private and Public hospital during May - December 2024, gathered using existing hospital incident reporting methods (Riskman reporting). It should be noted that this pilot study is not powered to detected statistically significant changes in the measures of effectiveness in reducing the incidence of falls.
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.

Survey data will be exported from Redcap software and analyzed using Stata v18 (StataCorp, College Station, TX). Quantitative data gathered from semi-structured caregiver surveys, documentation audits, caregiver and patient-family satisfaction surveys, and Riskman falls data will be analyzed using descriptive statistics (mean, standard deviation and percentages) and generalized linear mixed models to compare differences within the study wards over time. Analysis of both the incidence of falls and proportions of patients who fall will be performed using generalized estimating equations. Qualitative data from semi-structured survey comments and researcher field notes will be analyzed using thematic analysis. 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
24/10/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27118 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 43196 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 317420 0
Hospital
Name [1] 317420 0
St John of God Midland Public and Private Hospital
Country [1] 317420 0
Australia
Primary sponsor type
Hospital
Name
St John of God Midland Public and Private Hospital
Address
Country
Australia
Secondary sponsor category [1] 319704 0
None
Name [1] 319704 0
Address [1] 319704 0
Country [1] 319704 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316142 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 316142 0
Ethics committee country [1] 316142 0
Australia
Date submitted for ethics approval [1] 316142 0
15/11/2024
Approval date [1] 316142 0
Ethics approval number [1] 316142 0

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

Contacts
Principal investigator
Name 136918 0
Dr Chiara Naseri
Address 136918 0
St John of God Midland Public and Private Hospital. 1 Clayton St, Midland WA 6056
Country 136918 0
Australia
Phone 136918 0
+61 08 94624138
Fax 136918 0
Email 136918 0
chiara.naseri@sjog.org.au
Contact person for public queries
Name 136919 0
Dr Chiara Naseri
Address 136919 0
St John of God Midland Public and Private Hospital. 1 Clayton St, Midland WA 6056
Country 136919 0
Australia
Phone 136919 0
+61 08 94624138
Fax 136919 0
Email 136919 0
chiara.naseri@sjog.org.au
Contact person for scientific queries
Name 136920 0
Dr Chiara Naseri
Address 136920 0
St John of God Midland Public and Private Hospital. 1 Clayton St, Midland WA 6056
Country 136920 0
Australia
Phone 136920 0
+61 08 94624138
Fax 136920 0
Email 136920 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 (May 2026 - May 2031).
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo Reference list for ANZCTR Registration Reference List.pdf

Documents added automatically
No additional documents have been identified.