Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000243213
Ethics application status
Approved
Date submitted
2/01/2009
Date registered
12/05/2009
Date last updated
12/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cluster randomized trial to evaluate the effectiveness of low-low beds for the prevention of in-hospital falls
Scientific title
Does providing low-low beds to hospital wards reduce the risk of accidental falls amongst hospital patients compared to not having any low-low beds
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental bed falls amongst hospital patients 4468 0
Condition category
Condition code
Injuries and Accidents 4740 4740 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low-low beds are beds that are able to be lowered very close to the ground. Regular hospital beds cannot lower as close to the ground as low-low beds. Being nursed in a low-low bed makes it more difficult for people with delirium and gait instability to put themselves at risk of falling without resorting to using physical restraints. The model of low-low beds being used is the commercially available Huntleigh Healthcare "Sorrento" model. The intervention wards will be observed without any low-low beds for 6 months, then they will have the low-low beds for a period of 6 months. The intervention wards will receive 1 low-low bed for every 12 regular beds they have on a ward.
Intervention code [1] 3885 0
Prevention
Comparator / control treatment
Hosptial wards targeted will not have any low-low beds at project outset. The intervention group wards will receive 1 low-low bed for every 12 regular beds they have. The control group wards will not receive any low-low beds until the cessation of the trial follow-up period. The control wards will be observed without low-low beds for a period of 12 months. Both groups of wards will otherwise continue to provide standard hospital care.
Control group
Active

Outcomes
Primary outcome [1] 5606 0
Accidental falls and injuries arising from falls as recorded on hospital incident reporting systems
Timepoint [1] 5606 0
Accidental falls accrued over a 6 month period will be collect prior to study commencement to generate a control phase for both groups of wards. The intervention wards will then receive their beds during a 1 month period. Falls will then be monitored for a further 6 month period on both intervention and control group wards.
Secondary outcome [1] 9436 0
Falls resulting in injury are different to the primary outcome (all falls) because of the rating of the severity of the outcome of the fall by the staff member documenting the fall. Approximately 30% of all falls (primary outcome) are anticipated to result in injury (secondary outcome)
Timepoint [1] 9436 0
Falls resulting in injury accrued over a 6 month period will be collected prior to study commencement to generate a control phase for both groups of wards. The intervention wards will then receive their beds during a 1 month period. Falls resulting in injury will then be monitored for a further 6 month period on both intervention and control group wards.

Eligibility
Key inclusion criteria
Wards cannot already have access to low-low beds and must respond to the expression of interest distributed by project investigators.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric, intensive care and maternity wards will be excluded.

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)
An expression of interest will be e-mailed to all patient safety officers in Queensland. Patient safety officers in conjunction with ward unit managers will then provide gatekeeper consent for their ward (meeting inclusion/exclusion criteria) to participate. These wards will be the "clusters" that are the units of randomisation. Individual patients will not be directly approached to participate in this trial. Allocation will be conducted by contacting the holder of the allocation schedule who will be off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each ward of the 18 recruited wards will be matched on the basis of their recorded falls rates. A computer generated random number sequence will then by used separate one ward from each pair into either the intervention or control group. One investigator will arrange the ward pairs such that one ward is listed first and the other second. Another investigator (blinded to ward pairs and sequencing) and who is off site will develop the random number sequence and tell the first investigator which of the wards (the first or second listed ward) has been allocated to the intervention group on the basis of the next random number.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Matched cluster randomised trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4659 0
Other
Name [1] 4659 0
Queensland Health Patient Safety Centre
Country [1] 4659 0
Australia
Primary sponsor type
Individual
Name
Dr Terry Haines
Address
Allied Health Clinical Research Unit, Kingston Centre, Cnr Warrigal and Kingston Rds, Cheltenham, Victoria, Australia, 3192
Country
Australia
Secondary sponsor category [1] 3912 0
None
Name [1] 3912 0
Address [1] 3912 0
Country [1] 3912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6694 0
Queensland Health Human Research Ethics Committee
Ethics committee address [1] 6694 0
Ethics committee country [1] 6694 0
Australia
Date submitted for ethics approval [1] 6694 0
Approval date [1] 6694 0
21/05/2007
Ethics approval number [1] 6694 0
2007/014

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

Contacts
Principal investigator
Name 35068 0
Address 35068 0
Country 35068 0
Phone 35068 0
Fax 35068 0
Email 35068 0
Contact person for public queries
Name 12415 0
Dr Terry Haines
Address 12415 0
Allied Health Clinical Research Unit, Kingston Centre, Cnr Warrigal and Kingston Rds, Cheltenham, Victoria, Australia, 3192
Country 12415 0
Australia
Phone 12415 0
+61 3 92651774
Fax 12415 0
Email 12415 0
terrence.haines@med.monash.edu.au
Contact person for scientific queries
Name 3343 0
Dr Terry Haines
Address 3343 0
Allied Health Clinical Research Unit, Kingston Centre, Cnr Warrigal and Kingston Rds, Cheltenham, Victoria, Australia, 3192
Country 3343 0
Australia
Phone 3343 0
+61 3 92651774
Fax 3343 0
Email 3343 0
terrence.haines@med.monash.edu.au

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

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

Documents added automatically
No additional documents have been identified.