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Trial registered on ANZCTR


Registration number
ACTRN12617001226392
Ethics application status
Approved
Date submitted
10/08/2017
Date registered
22/08/2017
Date last updated
22/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Informing state-wide policy on the use of non-slip socks for preventing falls in admitted patients
Scientific title
Informing state-wide policy on the use of non-slip socks as an inpatient fall prevention measure: A cluster randomised controlled trial and economic evaluation
Secondary ID [1] 292021 0
None
Universal Trial Number (UTN)
U1111-1199-6847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 304128 0
Condition category
Condition code
Public Health 303460 303460 0 0
Health service research
Injuries and Accidents 303789 303789 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the ward-level provision of Non Slip Socks (NSS) to admitted patients, as pragmatically implemented by ward nursing staff. The most common strategy for NSS provision across other hospital sites in Queensland surveyed prior to the project development is to provide NSS to all admitted patients. This ‘provide-all’ approach is likely to be the most potent/efficacious and least costly strategy as it would not require any additional assessment.

In the week prior to the intervention phase, a 15-minute education session (made available twice a day at nursing handover) will be delivered by one of the research team providing information on the NSS and the trial. It will be up to nursing staff to make decisions regarding the provision of NSS, but our education will suggest to provide all patients with non-slip socks and to advise patients that NSS are to be worn if not wearing well fitting enclosed shoes. We anticipate that on transitioning to the intervention phase, all current patients will be provided with NSS and after that, individual wards will determine processes to ensure NSS are provided on admission, with the ability to provide a new pair to all patients when soiled beyond wear. The approaches adopted by each ward (process as prescribed by ward leadership and as carried out by clinicians) and overall usage will be monitored through periodic contact between the study project officer and ward nursing managers and other senior nursing staff.


The trial will be undertaken over 6 months. In line with the stepped wedge cluster RCT design all sites will commence as control wards a with individual wards moving into an intervention state (in random order) at the starts of month 2, 3, 4, 5 and 6. This will yield 15 months of control state data and 15 months of intervention state data.
Intervention code [1] 298674 0
Prevention
Comparator / control treatment
Usual care, where patients will be encouraged by clinical staff to use well-fitting closed footwear where available to mobilise (current best practice as per National Fall Prevention Guidelines and stated position of the Queensland Stay on Your Feet program). If patients are in possession of non-slip socks already, allowance/discouragement of their use will be dealt with as a clinical decision with advice from the West Moreton HHS fall prevention program staff (no specific guidance from this trial will be applied).

Due to the stepped wedge cluster RCT design of the present trial, control data will be collected from study wards prior to transition to the intervention state (where non-slip socks are provided).
Control group
Active

Outcomes
Primary outcome [1] 302849 0
Ward level rate of falls (number of falls per 1000 admitted patient days).

Fall data will be captured by reviewing clinical incident reports completed after falls in trial wards and periodic contact with ward managers to identify falls that might not have been reported. A list of medical records for which in-hospital falls have been coded, will also be extracted at the completion of the trial, and records without corresponding clinical incident reports will be manually searched.

To compute the falls rate, monthly bed occupancy data will be secured from the clinical coding service.
Timepoint [1] 302849 0
Monthly, for six months.
Primary outcome [2] 302850 0
The proportion of patients who have one or more falls as an inpatient (become a ‘faller’) in study wards during the control and intervention time periods.

The number of unique patients who experience a fall during the trial will be established by reviewing unique patient reference numbers recorded against falls compiled for primary end point 1. Errors in patient reference numbers will be verified with ward managers and by reviewing ward patient lists.
Timepoint [2] 302850 0
Monthly, for six months.
Secondary outcome [1] 337238 0
Adherence to protocol (snapshot audit of NSS usage) after transition to intervention state.
Timepoint [1] 337238 0
Weekly on study wards for six months (control and intervention periods). Control periods will be audited to confirm the absence of non-slip socks in the control state.

Eligibility
Key inclusion criteria
Due to the research design, all admitted patients to five 30-bed (+/-3) inpatient wards (one each of rehabilitation, general medical, acute care of the elderly wards and two surgical wards) will be included in the study. Wards that admit primarily children, obstetric patients, and those highly dependent on medical care such as intensive care will not be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not admitted to trial wards will not be able to participate.

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)
In the stepped wedge design, all participants (wards) will commence as control sites, but will transition to be intervention sites one ward at a time, at one-month intervals. The order of transition will be randomised, with the timing of transition concealed from staff in hospital wards until 2 weeks prior to transition. Hospital staff will not be blinded to group allocation (after allocation as occurred) as they will know at all times whether they are currently in the intervention or control phase (based on their access to non-slip socks).

The implementation sequence will be computer-generated by an off-site statistician not involved in the conduct of the trial (but will be involved in analysis). The research assistant monitoring adherence and conducting focus groups will also not be blind to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
A stepped-wedge cluster randomised controlled trial design will be used, where wards are the cluster level. In a stepped wedge cluster RCT, all clusters (wards) start in the control phase and transition to the intervention phase at fixed intervals but in random order until all wards are receiving the intervention. Between-ward variability in other factors will therefore be controlled for through the stepped-wedge design.

Due to the pragmatic nature of the trial individual patient-level consent was deemed to be not required by the approving HREC.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat (ITT) basis. The rate of falls (falls per 1000 patient bed days) and proportion of fallers between intervention and control time periods will be compared using multi-level mixed-effect negative binomial regression modelling. A patient’s fall(s) will be nested within the patient, while patients will be nested within wards. The effect of the socks will be considered a fixed effect, while patients and wards will be considered random effects. A covariate will be entered to adjust for seasonality in falls rates computed on the basis of twelve months of incident report data from each of the wards involved. Adherence data will be evaluated as a secondary analysis, with relative risk of falls between wards with high and low NSS compared.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2017
Actual
Date of last participant enrolment
Anticipated
25/12/2017
Actual
Date of last data collection
Anticipated
29/01/2018
Actual
Sample size
Target
3220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8588 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 16695 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 296552 0
Charities/Societies/Foundations
Name [1] 296552 0
Australian Centre for Health Services Innovation
Country [1] 296552 0
Australia
Primary sponsor type
Hospital
Name
West Moreton Hospital and Health Service
Address
West Moreton Hospital and Health Service
Chelmsford Ave, Ipswich QLD 4305
Country
Australia
Secondary sponsor category [1] 296083 0
None
Name [1] 296083 0
Address [1] 296083 0
Country [1] 296083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297766 0
West Moreton Hospital and Health Service HREC
Ethics committee address [1] 297766 0
Ethics committee country [1] 297766 0
Australia
Date submitted for ethics approval [1] 297766 0
08/03/2017
Approval date [1] 297766 0
19/05/2017
Ethics approval number [1] 297766 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1933 1933 0 0
/AnzctrAttachments/372998-(07-17) 2017.05.19 Signed HREC Approval Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 75050 0
Prof Sandy Brauer
Address 75050 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Queensland 4072
Country 75050 0
Australia
Phone 75050 0
+61 7 3365 2317
Fax 75050 0
Email 75050 0
[email protected]
Contact person for public queries
Name 75051 0
Leah Ireland
Address 75051 0
Occupational therapist / Project Officer
Ipswich Hospital
West Moreton Hospital and Health Service
Department of Health | Queensland Government
Chelmsford Avenue, Ipswich QLD 4305
Country 75051 0
Australia
Phone 75051 0
+61 7 3413 7688
Fax 75051 0
Email 75051 0
[email protected]
Contact person for scientific queries
Name 75052 0
Sandy Brauer
Address 75052 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Queensland 4072
Country 75052 0
Australia
Phone 75052 0
+61 7 3365 2317
Fax 75052 0
Email 75052 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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