Skip to content

Fall prevention through education and coaching trial (PROTECT)

Fall prevention through education and coaching (PROTECT): a stepped wedge type I hybrid trial of effectiveness and implementation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000896572
Acronym
PROTECT
Enrollment
315
Registered
2024-07-22
Start date
2024-09-04
Completion date
2026-02-26
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

Falls in hospital remain a common and costly problem but due to the complex intrinsic and extrinsic factors involved, no single approach or intervention has proved a panacea. This stepped wedge type I hybrid effectiveness-implementation trial will evaluate whether supported implementation (via quality improvement coaching and other tailored strategies) of tailored ward-based fall prevention interventions reduces patient falls in hospitals (primary objective). The impact of supported implementation of tailored ward-based fall prevention interventions on other fall related outcomes (e.g. falls injuries, unwitnessed falls), hospital acquired complications (e.g. pressure injuries and delirium), patient hospital length of stay, staff professional fulfilment and on a range of implementation outcomes and determinants will also be evaluated, as will the cost-effectiveness of the intervention. Routinely collected data from patient medical records and hospital databases will inform the primary outcome measure of rate of falls and some secondary effectiveness outcomes. Pre and post implementation patient and staff surveys, bedside audits and semi-structured interviews will inform secondary effectiveness and implementation outcomes. The primary hypothesis of this study is that supported implementation of tailored ward-based fall prevention interventions will reduce the rate of patient falls.

Interventions

This is a hybrid type I implementation effectiveness trial involving: a) Implementation strategies delivered by the research team to hospital ward staff to support them to implement tailored ward-based fall prevention interventions; and b) Evidence-informed intervention (tailored ward-based fall prevention interventions) implemented by ward staff within their routine workloads. Ward staff include those from nursing, allied health, medical, administrative and environmental services teams. The in

This is a hybrid type I implementation effectiveness trial involving: a) Implementation strategies delivered by the research team to hospital ward staff to support them to implement tailored ward-based fall prevention interventions; and b) Evidence-informed intervention (tailored ward-based fall prevention interventions) implemented by ward staff within their routine workloads. Ward staff include those from nursing, allied health, medical, administrative and environmental services teams. The intervention will be delivered in 3 steps at 5-month intervals. The intervention will be sequentially introduced into 12 wards (three clusters with each cluster containing four wards) across four hospitals over 15 months. Wards will be randomised into clusters which will determine the commencement date of the intervention. There will be a one month “wash in” period between the “control” and ‘Intervention’ phases where pre implementation surveys and quick ‘yes/no’ audits will be conducted with hospital staff and patients on the participating wards. Along with analysis of trends in routinely collected local falls data, these survey results will contribute to an individual ward falls profile. The completion of this will be supported by a quality improvement and a member of the study team experienced in hospital fall prevention. The intervention/s implemented by each ward will be locally tailored informed by the ward falls profile. The improvement science-based implementation strategy will involve the following: • Attendance by minimum two ward staff at a two-day face to face Improvement Science Education course run by Sydney Education at the start of the intervention period. This course will focus on improvement science training including using diagnostic data to inform change ideas, assessing and implementing change ideas, PDSA cycles, assessing, spreading and sustaining improvement. The course will use mixed modes of education, including presentations and interactive activities. • 16 weeks of intensive improvement science support by an experienced facilitator who will train and support clinical staff on improvement science methodology, and how ward clinicians can use this approach to implement fall prevention strategies as a patient safety initiative in their clinical areas, accommodating their working environment. The fall prevention strategies a ward chooses to implement will be informed by their ward's falls profile and evidence-based hospital fall prevention guideline. Training will be based on the needs of the participants. Examples of what this may include are: using available falls data to inform and evaluate change, practical understanding of how to adapt their way of working to reflect their distinct ward/area setting, work culture, patient acuity cohort and specific local challenges, implementing and managing change, and applying the theory of improvement science to falls prevention in a real-time clinical setting. The modes of training used will depend on the ward teams needs but may include didactic lectures, bedside education and interactive activities. Facilitation sessions will be at least weekly for 30-60 minutes, and the facilitator will be available for access at other times on an as-needs basis. • Inservice’s and local education to ward staff regarding evidence- based hospital fall prevention practice, provided by SLHD study team staff with fall prevention expertise. The topic, number and timing of in-services will be based on ward staff needs and preferences. • Creation of a community of practice for participating wards to share knowledge, challenges and success related to their involvement in the program. The community of practice will be designed based on the needs of the participants. Options for what it may involve include online channels for communication (e.g., Microsoft Teams), scheduled online or face to face meetings to share progress, challenges, etc. Additional implementation strategies may be created to meet individual ward needs based on their pre implementation needs profile (e.g. staff reminders by the bedside). The SLHD Fall Prevention and Management Guidelines, World Falls Prevention Guidelines and the Australian Fall Prevention Guidelines (due for release in November 2024) may be referenced throughout the program. Adherence to the intervention will be monitored via the implementation outcomes listed in this form. This will include strategies such as session attendance lists and questions on the study-specific questionnaires.

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

Trial participants: Inpatient hospital wards at 4 hospital sites across one local health district. Eligible wards will be acute or subacute, medical or surgical wards. Staff survey and interview participants: Staff employed by the participating hospital working in nursing, allied health, medical, administrative, or environmental services teams on a ward enrolled to participate in the intervention. Patient and family member/carer survey and interview participants: Admitted inpatient or family member/carer of admitted inpatient on participating ward, deemed cognitively and medically well enough to participate in a survey or interview as per Nurse Unit Manager of the ward’s clinical judgment.

Exclusion criteria

Trial participants: Emergency Departments, Intensive Care Units, Paediatric and neonatal wards, Wards currently participating in another research trial with patient falls as a listed outcome, Outpatient settings. Staff survey and interview participants: Has worked on the participating ward for less than one week. Patient and family member/carer survey and interview participants: Inpatient who has not spent any time on ward not participating in intervention; deemed not cognitively and/or medically well enough to participate in a survey as per the Nurse Unit Manager of the ward’s clinical judgment.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 21, 2026