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Trial registered on ANZCTR
Registration number
ACTRN12607000498493
Ethics application status
Not yet submitted
Date submitted
19/09/2007
Date registered
28/09/2007
Date last updated
28/09/2007
Type of registration
Prospectively registered
Titles & IDs
Public title
Preventing falls in the acute hospital setting.
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Scientific title
The effect of a multifactorial falls prevention program in preventing falls and injurious falls in an acute hospital setting.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute medical and surgical conditions.
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Condition category
Condition code
Injuries and Accidents
2478
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A sequential crossover design with a 20 week data collection period has been adopted. An A/B design is proposed with Phase A being non-intervention and Phase B – intervention. There are four components:
1.Research protocol standardisation training (e.g. what is a fall, what is an injurious fall, how do I report etc.) – this will ensure consistent data across both phases
2.Phase A – Pre-intervention data collection (10 weeks)
3.Intervention training
4.Phase B – Intervention data collection (10 weeks)
Education - All staff will attend meetings 1-2 days prior to each phase to be trained in research protocol standardisation and research interventions
The following interventions will be implemented for the duration of person’s admission within the 10 weeks of the intervention phase:
Falls Risk Flagging - Every admission will be screened (Have you had a fall in the last 12 months? Observe the patient stand from a chair, walk a short distance and return to sitting) and/or assessed (The Northern Hospital Modified Stratify Falls Risk Assessment Tool) as part of usual care. In the intervention phase falls risk will be flagged using an orange High Falls Risk Alert Sign on the person’s door, above the bed and on their walking aid. The person will also wear an orange arm band
Mobility and walking aids - Physiotherapy review will be undertaken on the morning of admission for people at high risk of falling. The physiotherapist will conduct a Timed Up and Go Test, issue an appropriate walking aid where indicated and conduct ongoing mobility and balance training as indicated.
Footwear – people at high risk of falling will be assessed by the admitting nurse for appropriate footwear as outlined in Australian Falls Prevention Guidelines. Those without appropriate footwear will be offered non-slip socks (GripSox™) for walking.
Medications - No new Benzodiazepine will be prescribed by any medical officer without consulting the hospital’s Consultant Physician.
Hydration Programme - Hourly water cues and toileting offers will be made during waking hours for cognitively impaired participants (i.e. defined as person’s with an Abbreviated Mental Test Score of <8). Water fountain with a “park bench” and reading material will be located on each ward as a place for wandering people to go. A “Happy Hour” where non-alcoholic mocktails, soft drinks, cordial and nibbles are served will be held 1-2 times per week and it will be targeted towards cognitively impaired people to improve hydration.
Supervision and surveillance - High Falls Risk Patients will never be left alone in the bathroom
Environment – A 7pm Light round will be conducted where all bathroom lights will be turned on in at night where no sensor light is fitted.
Fracture prevention - Hip protectors will be offered to anyone admitted with a low trauma fracture or anyone who has a diagnosis of osteoporosis
Vision - Patients are offered their own appropriate spectacles for every walk.
Low beds and appropriate height chairs – A breakfast bed and chair height round will be conducted where beds and chairs are set to popliteal crease height or lowest height, and meal tables will be placed within reach.
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Intervention code [1]
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Early detection / Screening
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Intervention code [2]
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Prevention
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Comparator / control treatment
Ususal Care
Defined as interventions conducted as part of a routine admission for a given condition. Usual care is guided by clinical pathways or individual clinical decisions by qualified health practitioners.
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Control group
Active
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Outcomes
Primary outcome [1]
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Falls per 1000 bed days.
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Assessment method [1]
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Timepoint [1]
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After 10 week intervention phase.
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Primary outcome [2]
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Injurious falls per 1000 bed days.
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Assessment method [2]
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Timepoint [2]
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After 10 week intervention phase.
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Primary outcome [3]
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Number of multiple fallers.
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Assessment method [3]
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Timepoint [3]
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After 10 week intervention phase.
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Secondary outcome [1]
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Benzodiazepine prescription volume.
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Assessment method [1]
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Timepoint [1]
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After 10 week intervention phase.
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Eligibility
Key inclusion criteria
Adult participants over the age of 18 years. The expected age range 18-100 years Patients being admitted to hospital
Ability to participate voluntarily and provide signed informed consent or access to an appropriate family member/guardian or carer who can provide signed informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The inability to provide signed informed consent or lack of an appropriate family member/guardian or carer who can provide signed informed consent.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/10/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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The Friendly Society Private Hopsital
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Address [1]
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Bundaberg QLD
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Health and Ageing Solutions
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Address
Brisbane QLD
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Medibank Private
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Address [1]
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Melbourne VIC
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Country [1]
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Australia
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Other collaborator category [1]
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University
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Name [1]
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Dr Trevor Russell
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Address [1]
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University of Queensland
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Country [1]
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Ethics committee address [1]
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Ethics committee country [1]
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Date submitted for ethics approval [1]
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10/09/2007
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Approval date [1]
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Ethics approval number [1]
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Summary
Brief summary
The primary purpose of this study is to investigate the hypothesis that a multifactorial, multidisciplinary falls prevention programme can prevent falls in an acute hospital setting.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Michael Bourke
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Address
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Health and Ageing Solutions
PO Box 884
Lutwyche
Brisbane QLD
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Country
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Australia
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Phone
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+617 33453255
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Fax
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+617 33453255
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Email
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michael.bourke@healthandageingsolutions.com
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Contact person for scientific queries
Name
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Michael Bourke
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Address
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Health and Ageing Solutions
PO Box 884
Lutwyche
Brisbane QLD
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Country
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Australia
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Phone
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+617 33453255
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Fax
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+617 33453255
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Email
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michael.bourke@healthandageingsolutions.com
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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.
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