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Cognitive Care Check (3Cs) for Prevention of Falls in Patients with Cognitive Impairment

Co-designed Caregiver Education for Prevention of Falls in Patients with Cognitive Impairment: a realist implementation, feasibility and preliminary effectiveness pilot study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001233516
Acronym
3Cs
Enrollment
200
Registered
2024-10-09
Start date
2025-05-01
Completion date
2025-10-24
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To address harm from falls in hospital that disproportionally affects older patients with cognitive impairment, St John of God Midland Private and Public hospital are committed to engaging patient and caregivers as partners in the design and transformation of practice through this realist evaluation of a co-designed dementia-specific caregiver education program. The question we are aiming to answer through the co-design process are, how can existing documentation tools for falls and cognition screening, assessment, and communication be regularly used by the multi-disciplinary team to identify patients with deteriorating mental state, and how can existing workflows be enhanced to support the patient with identified cognitive impairment? Caregiver participants and the researcher will purposefully engage in critical reflection during education sessions and on-ward training to understand real-life situations in their workplace, and create solutions by applying their experience-based knowledge to change practice. We hypothesize that the co-designed caregiver education will be feasible and cost-effective for the hospital and that caregivers will be more prepared to address falls prevention for patients with cognitive impairment, including engaging with their family.

Interventions

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 cogn

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.

Sponsors

St John of God Health Care
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026