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Trial registered on ANZCTR


Registration number
ACTRN12605000540617
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
28/09/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a multi-factorial, evidence-based approach to Falls Reduction in Residential Aged Care Facilities.
Scientific title
Reduction in falls injuries, especially hip fractures, within Residential Aged Care Facilities in the Hunter by employment of a project officer to support the implementation of a multifactorial falls prevention strategy by Residential Aged Care Facilities.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall resulting in fractured neck of femur. 667 0
Condition category
Condition code
Injuries and Accidents 740 740 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a multifactorial strategy that addresses falls risk at an individual resident and systems level. The main engine for the intervention is the falls project officer who will liase with intervention facilities to determine their current approaches to falls prevention and to facilitate the adoption of falls prevention strategies that have been found to be effective in other settings. These strategies include falls risk assessment, reduction of environmental hazards, physical activity, calcium and vitamin D supplementation, general nutrition, medication review, review of restraint policy.Evaluation of the intervention will involve a number of low and high care lodges from residential aged care facilities across the Hunter and enable comparison of outcomes for residents in lodges that are allocated to receive the intervention and control lodges. Because the intervention is holistic and is aimed at the environment and culture surrounding the residents, whole facilities (lodges) will be selected for random allocation to intervention or control conditions. Randomisation will occur using a technique of minimisation to ensure intervention and control lodges are balanced for: number of residents, level of care, and dementia specific units. A total eighty lodges will be randomly allocated in this way, with a minimum of 20 residents per lodge.Baseline measures will be collected over four months. This will be followed by a one month washout period when staff in the intervention facilities are trained in the intervention. The intervention will then be implemented for a 12 month period to allow for monitoring of the impact of the intervention on falls risk and other outcomes.Following randomisation and prior to administration of the intervention, a census of non respite residents will be undertaken and these will form the intervention and control cohorts that will be followed.
Intervention code [1] 470 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 917 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels.1. Group Level: Time-series evaluation. The evaluation will assess whether the intervention has resulted in an overall reduction in the number of fall-related fractured neck of femur in the intervention lodges when compared to control lodges. A two-group time series design will be used to assess this effect. Time series data on the monthly number of falls. All residents in the facilities will be included in these analyses.
Timepoint [1] 917 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [2] 918 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels.1. Group Level: Time-series evaluation. The evaluation will assess whether the intervention has resulted in an overall reduction in the number of fall-related fractured neck of femur in the intervention lodges when compared to control lodges. A two-group time series design will be used to assess this effect. Time series data on the monthly number of falls with injury. All residents in the facilities will be included in these analyses.
Timepoint [2] 918 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [3] 919 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels.1. Group Level: Time-series evaluation. The evaluation will assess whether the intervention has resulted in an overall reduction in the number of fall-related fractured neck of femur in the intervention lodges when compared to control lodges. A two-group time series design will be used to assess this effect. Time series data on the monthly number of any fracture. All residents in the facilities will be included in these analyses.
Timepoint [3] 919 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [4] 920 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels.1. Group Level: Time-series evaluation. The evaluation will assess whether the intervention has resulted in an overall reduction in the number of fall-related fractured neck of femur in the intervention lodges when compared to control lodges. A two-group time series design will be used to assess this effect. Time series data on the monthly number of hip fracture. All residents in the facilities will be included in these analyses.
Timepoint [4] 920 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [5] 921 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels.1. Group Level: Time-series evaluation. The evaluation will assess whether the intervention has resulted in an overall reduction in the number of fall-related fractured neck of femur in the intervention lodges when compared to control lodges. A two-group time series design will be used to assess this effect. Time series data on the monthly number death will be compared for intervention and control facilities. All residents in the facilities will be included in these analyses.
Timepoint [5] 921 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [6] 922 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels. 2. The second level is a more rigorous assessment of the effectiveness of the intervention in reducing the risk of fractured neck of femur for the residents who are in the selected lodges at the start of the intervention period. Cox regression analysis will be used to assess time to first fall.
Timepoint [6] 922 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [7] 923 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels. 2. The second level is a more rigorous assessment of the effectiveness of the intervention in reducing the risk of fractured neck of femur for the residents who are in the selected lodges at the start of the intervention period. Cox regression analysis will be used to assess time to first injurous fall.
Timepoint [7] 923 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [8] 924 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels. 2. The second level is a more rigorous assessment of the effectiveness of the intervention in reducing the risk of fractured neck of femur for the residents who are in the selected lodges at the start of the intervention period. Cox regression analysis will be used to assess time to first fracture resulting from a fall.
Timepoint [8] 924 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [9] 925 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels. 2. The second level is a more rigorous assessment of the effectiveness of the intervention in reducing the risk of fractured neck of femur for the residents who are in the selected lodges at the start of the intervention period. Cox regression analysis will be used to assess time to first hip fracture resulting from a fall.
Timepoint [9] 925 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Primary outcome [10] 926 0
The primary outcome is a fall resulting in fractured neck of femur.Evaluation of the effectiveness of the intervention will occur at two levels. 2. The second level is a more rigorous assessment of the effectiveness of the intervention in reducing the risk of fractured neck of femur for the residents who are in the selected lodges at the start of the intervention period. Cox regression analysis will be used to assess survival.
Timepoint [10] 926 0
All outcomes will be measured monthly over a twelve month period and will be analysed at the end of this period.
Secondary outcome [1] 1774 0
Secondary outcomes are: falls, fall with injury (other than fractured neck of femur), death.
Timepoint [1] 1774 0
Secondary outcome [2] 1775 0
Process outcomes are: adoption of falls reduction strategies.
Factors surrounding fall-related events will also be described. Objectives within the project will include: to develop an appropriate, evidence-based multi-factorial program to reduce hip fractures in aged care facilities; to test and document the feasibility of implementing the program; to engage relevant stakeholders and project partners, including general practitioners; to document the resources required to successfully implement the program; to explore the sustainability of the intervention, notably with respect to identification of the resources required for ongoing maintenance of the intervention; to develop a model of intervention to be implemented across other Area Health Services in NSW and beyond.
In addition, the study should add to our knowledge of the nature and causes of hip fractures in aged care facilities, particularly in the areas of: the important risk factors for falls resulting in hip fractures; the morbidity and mortality resulting from falls in aged care facilities; the most appropriate assessment tools for aged care facilities; which groups of residents are most likely to respond to a preventative program.
Timepoint [2] 1775 0

Eligibility
Key inclusion criteria
Residential Aged Care Facilities with 20 beds or greater. All non respite residents in the Residential Aged Care Facilities at the beginning of the intervention period.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Aged care residences will know whether or not they have been included in the intervention group. Residents will not be informed of their institution's group status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sample will be drawn from each of the following five bed categories: 1. High care only; 2. High and low care + dementia specific; 3. High and low care only; 4. Low care + dementia specific and; 5. Low care only. SAS computer software will be used to generate the random sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 822 0
Government body
Name [1] 822 0
NSW Health Promotion Demonstration Research Grant Scheme 2004/2005
Country [1] 822 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 687 0
University
Name [1] 687 0
University of Newcastle
Address [1] 687 0
Country [1] 687 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2089 0
Hunter New England Area Health service
Ethics committee address [1] 2089 0
Ethics committee country [1] 2089 0
Australia
Date submitted for ethics approval [1] 2089 0
Approval date [1] 2089 0
Ethics approval number [1] 2089 0

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

Contacts
Principal investigator
Name 35517 0
Address 35517 0
Country 35517 0
Phone 35517 0
Fax 35517 0
Email 35517 0
Contact person for public queries
Name 9659 0
Dr John Ward
Address 9659 0
Community, Aged and Rehabilitation Extended Services (CARE) Network
Hunter New England Area Health Service
Locked Bag 119
Wallsend NSW 2287
Country 9659 0
Australia
Phone 9659 0
+61 2 49246004
Fax 9659 0
+61 2 49246006
Email 9659 0
John.Ward@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 587 0
Prof Julie Byles
Address 587 0
Royal Newcastle Hospital
Room 266
David Madisson Building
Watt Street
Newcastle NSW 2300
Country 587 0
Australia
Phone 587 0
+61 2 49236643
Fax 587 0
+61 2 49236148
Email 587 0
julie.byles@newcastle.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.