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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Falls

Immobility

Health literacy

Condition category

Condition code

Injuries and Accidents

Fractures

Physical Medicine / Rehabilitation

Physiotherapy

Public Health

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]

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]

Caregiver acceptability of the co-produced education for intervention A and B

Timepoint [1]

Immediately following caregiver education delivery, prior to intervention phase and following informed consent of the caregiver receiving the education

Primary outcome [2]

Fidelity of Intervention A and B delivery and integration into moments of care at cluster level

Timepoint [2]

on a weekly basis throughout the trial.

Primary outcome [3]

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]

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]

Number of falls on study wards / clusters

Timepoint [1]