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Feasibility and preliminary efficacy of a Hospital Fall Prevention Moments of Care intervention: a pilot trial

Feasibility and preliminary efficacy of a Hospital Fall Prevention Moments of Care intervention: a pilot trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001238662
Enrollment
20000
Registered
2023-11-30
Start date
2024-02-15
Completion date
2024-07-31
Last updated
2024-06-24

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

Conditions

None listed

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.

Interventions

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

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.

Sponsors

St John of God Midland Public and Private Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

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

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.

Exclusion criteria

No exclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026