Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
Scientific title
The effect of a multifactorial falls prevention program in preventing falls and injurious falls in an acute hospital setting.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute medical and surgical conditions. 2373 0
Condition category
Condition code
Injuries and Accidents 2478 2478 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 2095 0
Early detection / Screening
Intervention code [2] 2096 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 3372 0
Falls per 1000 bed days.
Timepoint [1] 3372 0
After 10 week intervention phase.
Primary outcome [2] 3373 0
Injurious falls per 1000 bed days.
Timepoint [2] 3373 0
After 10 week intervention phase.
Primary outcome [3] 3374 0
Number of multiple fallers.
Timepoint [3] 3374 0
After 10 week intervention phase.
Secondary outcome [1] 5593 0
Benzodiazepine prescription volume.
Timepoint [1] 5593 0
After 10 week intervention phase.

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2624 0
Commercial sector/Industry
Name [1] 2624 0
The Friendly Society Private Hopsital
Country [1] 2624 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Health and Ageing Solutions
Address
Brisbane QLD
Country
Australia
Secondary sponsor category [1] 2373 0
Commercial sector/Industry
Name [1] 2373 0
Medibank Private
Address [1] 2373 0
Melbourne VIC
Country [1] 2373 0
Australia
Other collaborator category [1] 45 0
University
Name [1] 45 0
Dr Trevor Russell
Address [1] 45 0
University of Queensland
Country [1] 45 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4554 0
Ethics committee address [1] 4554 0
Ethics committee country [1] 4554 0
Date submitted for ethics approval [1] 4554 0
10/09/2007
Approval date [1] 4554 0
Ethics approval number [1] 4554 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28052 0
Address 28052 0
Country 28052 0
Phone 28052 0
Fax 28052 0
Email 28052 0
Contact person for public queries
Name 11209 0
Michael Bourke
Address 11209 0
Health and Ageing Solutions
PO Box 884
Lutwyche
Brisbane QLD
Country 11209 0
Australia
Phone 11209 0
+617 33453255
Fax 11209 0
+617 33453255
Email 11209 0
[email protected]
Contact person for scientific queries
Name 2137 0
Michael Bourke
Address 2137 0
Health and Ageing Solutions
PO Box 884
Lutwyche
Brisbane QLD
Country 2137 0
Australia
Phone 2137 0
+617 33453255
Fax 2137 0
+617 33453255
Email 2137 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

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

Documents added automatically
No additional documents have been identified.