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Trial registered on ANZCTR


Registration number
ACTRN12624000896572p
Ethics application status
Submitted, not yet approved
Date submitted
2/07/2024
Date registered
22/07/2024
Date last updated
22/07/2024
Date data sharing statement initially provided
22/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Fall prevention through education and coaching trial (PROTECT)
Scientific title
Fall prevention through education and coaching (PROTECT): a stepped wedge type I hybrid trial of effectiveness and implementation
Secondary ID [1] 312378 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROTECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 334169 0
Condition category
Condition code
Public Health 330837 330837 0 0
Health service research
Injuries and Accidents 331033 331033 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328874 0
Prevention
Intervention code [2] 328896 0
Behaviour
Comparator / control treatment
The stepped wedge trial design allows wards to act as controls and subsequently intervention groups. During the pre-intervention control phases, wards will provide fall prevention management and interventions as is current practice on their wards. This includes fall risk assessments and prevention strategies informed by the LHD Fall Prevention Strategy. The specific interventions delivered as part of current practice varies between facilities and wards.
Control group
Active

Outcomes
Primary outcome [1] 338607 0
Rate of falls per 1000 patient bed days.
Timepoint [1] 338607 0
At the conclusion of study.
Secondary outcome [1] 436569 0
Rate of injurious falls.
Timepoint [1] 436569 0
At the conclusion of study.
Secondary outcome [2] 436572 0
Rate of unwitnessed falls.
Timepoint [2] 436572 0
At the conclusion of study.
Secondary outcome [3] 436574 0
Incidence of hospital acquired delirium.
Timepoint [3] 436574 0
At the conclusion of the study.
Secondary outcome [4] 436576 0
Incidence of hospital acquired pressure injuries.
Timepoint [4] 436576 0
At the conclusion of the study.
Secondary outcome [5] 436577 0
Patient length of stay.
Timepoint [5] 436577 0
At the conclusion of the study.
Secondary outcome [6] 436578 0
Staff reported patient mobility patterns (no between group comparison).
Timepoint [6] 436578 0
Four months post implementation commencement.
Secondary outcome [7] 436579 0
Patient fear of falling.
Timepoint [7] 436579 0
At the conclusion of the study.
Secondary outcome [8] 436580 0
Staff professional fulfilment (intervention group only, within group measure).
Timepoint [8] 436580 0
Pre-implementation surveys will be conducted one month prior to intervention implementation. Post-implementation surveys and qualitative interviews will be conducted 4 months post-commencement of intervention implementation.
Secondary outcome [9] 436582 0
Implementation outcome: Adoption - proportion of ward staff that deliver tailored fall prevention intervention (intervention group only, within group measure).
Timepoint [9] 436582 0
Pre-implementation surveys will be conducted one month prior to intervention implementation. Post-implementation surveys and qualitative interviews will be conducted 4 months post-commencement of intervention implementation. Audit of study records at conclusion of the study.
Secondary outcome [10] 436584 0
Implementation outcome: Reach - Proportion of patients provided with fall prevention interventions (intervention group only, within group measure).
Timepoint [10] 436584 0
Pre-implementation surveys will be conducted one month prior to intervention implementation. Post-implementation surveys, qualitative interviews/ focus groups and ward audit will be conducted 4 months post-commencement of intervention implementation.
Secondary outcome [11] 436585 0
Implementation outcome: Dose - extent of delivery of intervention and implementation strategies delivered (intervention group only, within group measure).
Timepoint [11] 436585 0
Pre-implementation surveys will be conducted one month prior to intervention implementation. Post-implementation surveys and qualitative interviews/focus groups will be conducted 4 months post-commencement of intervention implementation. Ward audits will be conducted 4 months post-commencement of the intervention. Audit of study records will be carried out at the conclusion of the study.
Secondary outcome [12] 436865 0
Implementation outcome: Fidelity - extent to which interventions and implementation strategies are delivered following protocol (no between group comparison).
Timepoint [12] 436865 0
Interviews and focus groups: 4 months post-implementation commencement. Study records at the conclusion of the study.
Secondary outcome [13] 436867 0
Implementation determinant: Acceptability of the implementation strategies - staff views on acceptability of intervention and implementation strategies (no between group comparison).
Timepoint [13] 436867 0
4 months post-implementation commencement.
Secondary outcome [14] 436869 0
Implementation determinant: Self-efficacy - staff confidence applying tailored fall prevention interventions (no between group comparison).
Timepoint [14] 436869 0
4 months post intervention commencement.
Secondary outcome [15] 436870 0
Implementation determinant: Appropriateness - extent to which the fall prevention interventions fit with ward needs (no between group comparison).
Timepoint [15] 436870 0
4 months post-implementation commencement.
Secondary outcome [16] 436871 0
Implementation determinant: Satisfaction- staff satisfaction with the impact of the intervention and implementation strategies (no between group comparison).
Timepoint [16] 436871 0
4 months post-implementation commencement.
Secondary outcome [17] 437460 0
Implementation determinant: Satisfaction- patient satisfaction with the impact of the intervention (no between group comparison).
Timepoint [17] 437460 0
4 months post-implementation commencement.
Secondary outcome [18] 437496 0
Cost-effectiveness of the supported implementation of ward-based fall prevention interventions compared to usual care (cost-effectiveness aim) from the perspective of a Local Health District.

Timepoint [18] 437496 0
At the conclusion of the study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospitals and wards will be randomly allocated a unique code. A separate statistician not involved with the study then will randomly allocate wards using computer software to the stepped-wedge sequence at the beginning of the trial using the unique codes provided. Allocation will be based on clusters.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The groups of wards will be randomised with a secure computer-based system to start the intervention in one of three 4-month time periods. Randomisation of all groups will occur once 12 wards have been enrolled in the study and prior to the commencement of any intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Our design will provide 80% power to detect as significant, at the 5% level, a 25% lower fall rate for intervention than control phases (IRR = 0.75). To determine the appropriate sample size for the complete stepped-wedge design, we used the Stata function “steppedwedge”. We considered setting a at 0.05 and assuming, conservatively, that the intra-cluster correlation 0.007. The main outcome variable was the falls rate, a binary outcome. Based on inpatient falls monitoring data, we observed around 40 falls per 10,000 bed days. This equates to control falls rate being 0.01 and a 25% reduction in intervention would be rate of 0.0375. For three steps and four clusters per sequence, we will need 30 beds per ward. This will result in 14,400 bed days in four wards for 120 days (3 months). This will equate to >80% power.

Sample size calculations for the pre and post implementation surveys have been calculated using paired mean t-tests with survey data from our feasibility study, using standard deviations of 0.8. These analyses reveal the proposed sample sizes will have 80% power to detect changes of 0.5 in the Likert scale survey questions.

Statistical analysis will compare the rate of falls (primary outcome), injurious falls (secondary outcomes) across time periods using generalised linear mixed models. Secondary analyses using causal modelling will be conducted to establish intervention effects in wards with greater uptake. Analyses will follow a pre-specified statistical analysis plan, will be conducted while masked to group allocation and will use an intention-to-treat approach. Analyses will utilise Stata and R and led by experienced SLHD biostatistician AI Kishore Biswas. Sensitivity analyses to adjust for potential risks of bias will be conducted e.g. a sensitivity analysis adjusting for potential clustering by trainer to address the risk that the efficacy of the intervention may be influenced by the fact that wards have the same trainer.

Quantitative implementation analysis will involve numerical description of qualitative implementation measures, presented as percentages or means and exploration with relative risks. All returned surveys that have at least one response will be included for analysis. Descriptive statistics (means, standard deviations (SD), change, counts and percentages) will be used to analyse survey data. Changes from pre to post delivery of implementation strategies in self-reported patient/ family and staff surveys implementation outcome measures will be evaluated using paired- sample t-tests. Univariate correlations will explore changes in these measures.

Qualitative implementation analysis will involve semi-structured interviews and/or focus groups with thematic analysis to explore manager, frontline staff, coach and patient experiences of the intervention (acceptability, barriers and facilitators).

A trial based economic evaluation will be conducted from the SLHD perspective and the time horizon will be limited to the trial duration. All intervention implementation and delivery costs (from study records), including staff and equipment costs, and all health service utilisation costs (from hospital records) during the trial period (pre-intervention, intervention and follow-up periods) will be used for the analysis. Using mean costs and mean health outcomes in each trial period, the incremental cost per additional fall prevented of the intervention periods compared with control periods will be calculated using the following formula:
Incremental Cost-Effectiveness Ratio=[mean costs (intervention periods)- average costs (control periods)] / [average effects (intervention periods)-average effects (control periods)].

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
4/10/2024
Actual
Date of last data collection
Anticipated
26/02/2026
Actual
Sample size
Target
5808
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26715 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 26716 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 26717 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 26718 0
Balmain Hospital - Balmain
Recruitment postcode(s) [1] 42754 0
2050 - Camperdown
Recruitment postcode(s) [2] 42755 0
2139 - Concord
Recruitment postcode(s) [3] 42756 0
2194 - Campsie
Recruitment postcode(s) [4] 42757 0
2041 - Balmain

Funding & Sponsors
Funding source category [1] 316784 0
Government body
Name [1] 316784 0
National Health and Medical Research Council
Country [1] 316784 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319005 0
University
Name [1] 319005 0
University of Sydney
Address [1] 319005 0
Country [1] 319005 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315552 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315552 0
Ethics committee country [1] 315552 0
Australia
Date submitted for ethics approval [1] 315552 0
05/04/2024
Approval date [1] 315552 0
Ethics approval number [1] 315552 0

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

Contacts
Principal investigator
Name 135062 0
Prof Cathie Sherrington
Address 135062 0
Level 10N, King George V Building, RPA 83/117 Missenden Road, Camperdown NSW 2050
Country 135062 0
Australia
Phone 135062 0
+61 418225929
Fax 135062 0
Email 135062 0
cathie.sherrington@sydney.edu.au
Contact person for public queries
Name 135063 0
Charlotte McLennan
Address 135063 0
Sydney Local Health DistrictLevel 10N, King George V Building, RPA 83/117 Missenden Road, Camperdown NSW 2050
Country 135063 0
Australia
Phone 135063 0
+61 439402149
Fax 135063 0
Email 135063 0
charlotte.mclennan@health.nsw.gov.au
Contact person for scientific queries
Name 135064 0
Charlotte McLennan
Address 135064 0
Level 10N, King George V Building, RPA 83/117 Missenden Road, Camperdown NSW 2050
Country 135064 0
Australia
Phone 135064 0
+61 439402149
Fax 135064 0
Email 135064 0
charlotte.mclennan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.