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Trial registered on ANZCTR


Registration number
ACTRN12616000065493
Ethics application status
Approved
Date submitted
18/01/2016
Date registered
21/01/2016
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A pragmatic approach to developing falls prevention interventions in a hospital setting.
Scientific title
A pragmatic approach to developing falls prevention interventions in a hospital setting.
Secondary ID [1] 288217 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older people 297126 0
Condition category
Condition code
Injuries and Accidents 297361 297361 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will be a pre-post design involving detailed collection of historical, current and prospective falls and falls prevention strategy implementation data. For 10 weeks, data related to every fall on the ward/unit at each site will be collected. The data will be extensively analysed for patterns and trends. This period will take approximately 2 weeks. Generic and individualised falls prevention strategies (e.g.patient and relative education, post fall reviews, staff education, toileting regimes, review of use of bed rails, movement devices, low-low beds, medication reviews, exercise, management of dizziness, syncope, postural hypotension or delirium, environmental modification, footwear advice) will be developed based on the locally-derived data. Appropriate interventions for each site will be determined from this analysis and implemented for 10 weeks. Adherence to the intervention will be collected in the 10 week period including prospective falls data and by staff recording for all admissions on a checklist whether the intervention has been implemented. A model will be developed based on proven interventions but content informed by the local context and data collected and education of staff will occur.
Intervention code [1] 293511 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296914 0
Identification from locally driven data of risk factors for falling at 2 sites using the post fall data collection sheet (developed for project)
Timepoint [1] 296914 0
At the end of 10 weeks of prospective falls data collection period
Primary outcome [2] 297103 0
Feasibility of implementing a framework of pragmatic analysis and context driven intervention for falls prevention measured by a qualitative questionnaire including ability to retrieve local data, time to collect local data, barriers to obtaining data, the ability of sites to implement the plan, and the identification of barriers to implementing the plan.
Timepoint [2] 297103 0
At the end of the 10 weeks falls prevention intervention phase
Secondary outcome [1] 319686 0
Rates of falls at each site as measured by number of falls and number of injurious falls per occupied bed days. Data will be collected by reviewing currently used falls reporting documents.
Timepoint [1] 319686 0
At 3 time points:
1. prior to the start of prospective falls data collection period
2. at the end of the 10 week prospective falls data collection period
3. at the end of the 10 week falls prevention intervention phase
Secondary outcome [2] 320025 0
Staff and patient knowledge and perceptions of falls prevention by knowledge and perception survey designed specifically for this study
Timepoint [2] 320025 0
At 2 time points:
1. prior to the start of prospective falls data collection period
2.at the end of the 10 week falls prevention intervention phase
Secondary outcome [3] 320026 0
Embedding of improved clinical practice for falls prevention by staff behaviour feedback survey designed specifically for this study
Timepoint [3] 320026 0
At 2 time points:
1. prior to the start of prospective falls data collection period
2.at the end of the 10 week falls prevention intervention phase
Secondary outcome [4] 320069 0
Rate of recurrent falls at each site as measured by identifying the number of falls per patient per occupied bed days. Data will be collected by reviewing currently used falls reporting documents.
Timepoint [4] 320069 0
At 2 time points:
1. prior to the start of prospective falls data collection period
2.at the end of the 10 week falls prevention intervention phase
Secondary outcome [5] 320070 0
Rate of injurious falls at each site as measured by number of injurious falls per occupied bed days. Data will be collected by reviewing currently used falls reporting documents.
Timepoint [5] 320070 0
At 2 time points:
1. prior to the start of prospective falls data collection period
2.at the end of the 10 week falls prevention intervention phase

Eligibility
Key inclusion criteria
Participants will include patients and staff from the two nominated sites :
Melbourne Health: APU (Assessment and Planning Unit, soon to be known as Acute Medical Unit (AMU), City Campus
Austin Health: Ward 10 (Acute aged care), Heidelberg Repatriation Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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
Data will be analysed by NARI research staff using qualitative and quantitative methods. The individual falls data will be analysed to detect patterns and trends for local falls risk factors. The number of participants included reflects the clinical nature of the local context - for patients this includes all those admitted to the nominated ward/unit for the study period; for staff this includes all those who work on the nominated ward/unit during the study period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
22/03/2016
Date of last participant enrolment
Anticipated
12/02/2017
Actual
12/02/2017
Date of last data collection
Anticipated
12/02/2017
Actual
12/02/2017
Sample size
Target
210
Accrual to date
Final
288
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4992 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 4994 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 12480 0
3052 - Parkville
Recruitment postcode(s) [2] 12481 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 292604 0
Other Collaborative groups
Name [1] 292604 0
Melbourne Ageing Research Collaboration (MARC)
Country [1] 292604 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Ageing Research Institute
Address
PO Box 2127 Royal Melbourne Hospital Victoria 3050
Country
Australia
Secondary sponsor category [1] 291321 0
None
Name [1] 291321 0
N/A
Address [1] 291321 0
N/A
Country [1] 291321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294085 0
Melbourne Health HREC
Ethics committee address [1] 294085 0
Ethics committee country [1] 294085 0
Australia
Date submitted for ethics approval [1] 294085 0
03/12/2015
Approval date [1] 294085 0
16/12/2015
Ethics approval number [1] 294085 0
AU RED HREC Reference Number: HREC/15/MH/357

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

Contacts
Principal investigator
Name 62394 0
Dr Frances Batchelor
Address 62394 0
National Ageing Research Institute
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 62394 0
Australia
Phone 62394 0
61 3 83872383
Fax 62394 0
61 3 93874030
Email 62394 0
f.batchelor@nari.unimelb.edu.au
Contact person for public queries
Name 62395 0
Sue Williams
Address 62395 0
National Ageing Research Institute
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 62395 0
Australia
Phone 62395 0
61 3 83872614
Fax 62395 0
61 3 93874030
Email 62395 0
s.williams@nari.unimelb.edu.au
Contact person for scientific queries
Name 62396 0
Sue Williams
Address 62396 0
National Ageing Research Institute
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 62396 0
Australia
Phone 62396 0
61 3 83872614
Fax 62396 0
61 3 93874030
Email 62396 0
s.williams@nari.unimelb.edu.au

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Results publications and other study-related documents

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