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Trial registered on ANZCTR


Registration number
ACTRN12619000103167
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
24/01/2019
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing Hospital Falls: Optimal Screening
Scientific title
Validity of Falls Risk Assessment (FRAT) Forms in Hospitals
Secondary ID [1] 296914 0
Nil
Universal Trial Number (UTN)
U1111-1225-8450
Trial acronym
EMPOWER-FRAT
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Falls 310866 0
Condition category
Condition code
Public Health 309536 309536 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the experimental group hospitals, we shall replace the old Falls Risk Assessment Tool (called FRATA) with a new form (called FRATB) that does not assign a score to falls risk screening yet includes the other elements.

The "intervention" is filling in the FRAT forms and will be done within 24 hours after a patient is admitted and then repeated during the hospital stay if the falls risk changes. The FRAT takes approximately 5-10 minutes for nurses and health professionals to fill in.

For the intervention, the actual risk screening assessment form used by healthcare professionals shall contain information needed to assign ratings. The procedure will be for the registered nurses and other registered health professionals to fill in the risk screening assessment at the patient admission and then repeat filling in the form if the patient status changes. They will do this by meeting with the individual hospital patients, reading the history and making an informed decision about risk. The location where the intervention occurs will always be an Australian hospital or rehabilitation facility. An independent data monitoring committee will monitor falls in the included hospitals. An independent assessor will monitor fidelity by cross checking at least 20% of the medical histories for the people found to fall.
Intervention code [1] 313197 0
Early detection / Screening
Comparator / control treatment
Usual care. For the control group, the historical FRAT screening tool (FRATA) will be used to assign a falls risk score to patients and corresponding fall prevention management strategies will continue according to usual care.
Control group
Active

Outcomes
Primary outcome [1] 318500 0
The primary outcome measure will be fall rates (per 1000 bed days), derived from the hospital “Riskman” incident management system.
Timepoint [1] 318500 0
June 2019
Secondary outcome [1] 365170 0
(i) estimated FRAT /clinician judgement form documentation completions using compliance audits in intervention and control hospitals. Assessments will be done of at least 100 patient histories from each hospital site to check that clinicians have completed the correct form and the extent to which they complete them correctly. This outcome is assessed with a study-specific questionnaire.
Timepoint [1] 365170 0
June 2019
Secondary outcome [2] 365344 0
(ii) Estimated difference in time taken to complete traditional FRAT and new screening forms. At least 30 clinicians will be timed completing the traditional FRAT and new screening forms. This outcome is assessed with a stop watch and study-specific questionnaire.
Timepoint [2] 365344 0
June 2019
Secondary outcome [3] 365345 0
(iii) whether any differences are detected in time attributed to fall prevention actions in response to either FRAT form. Assessments will be done of at least 100 patient histories from each hospital site to check the time attributed to fall prevention actions in response to either FRAT form. This outcome is assessed with a study-specific questionnaire.
Timepoint [3] 365345 0
June 2019
Secondary outcome [4] 365346 0
(iv) fidelity of screening type (per hospital group allocation). This outcome is assessed with a stop watch and study-specific questionnaire.
Timepoint [4] 365346 0
June 2019
Secondary outcome [5] 365347 0
(v) Inpatient-fall-related healthcare resource use for participants in each trial arm. This will be estimated from fall-related incident reports, audits of healthcare resources consumed for serious fall-related injury cases that consume substantial healthcare resources (e.g., fractures, head injuries), and use of hospital administrative records for participants in each trial arm.
Timepoint [5] 365347 0
June 2019
Secondary outcome [6] 365398 0
Labour consumed for fall prevention-related activities (based on estimates of time taken to complete fall-risk screening and fall-prevention activities actions) will also contribute to clinician labour time estimates for inpatient-fall-related healthcare resource use. This outcome is assessed with a stop watch and study-specific questionnaire.
Timepoint [6] 365398 0
June 2019

Eligibility
Key inclusion criteria
All wards (except paediatric, maternity, emergency and theatre wards) will be sampled from 10 Private hospitals in Australia.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric, maternity, emergency and theatre wards.

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)
The hospitals will be randomised by another organisation to either (1) continuing to use the current Hospital FRAT form or (2) using a new form that removes the risk assessment elements yet maintains other components for falls mitigation.

Allocation concealment ensured that hospital managers were unaware, when this decision was made, to which group their hospital would be allocated. Allocation was concealed and involved contacting the holder of the allocation schedule who was "off-site" at an Australian university not participating in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation for group A or B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The study is a cluster randomized control trial where hospitals are randomised to group A or group B
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be conducted following intention-to-treat principles, accounting for non-independence (clustering). In-hospital fall rates (per 1000 occupied bed days) will be reported (and compared between groups) to determine whether Form B is non-inferior to traditional FRAT completion (Form A). Secondary outcomes will be compared between groups using generalised linear mixed models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 301485 0
Government body
Name [1] 301485 0
National Health and Medical Research Council
Address [1] 301485 0
414 La Trobe St, Melbourne VIC 3000
Country [1] 301485 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 301179 0
Commercial sector/Industry
Name [1] 301179 0
Healthscope
Address [1] 301179 0
1/312 St Kilda Rd, Melbourne VIC 3004
Country [1] 301179 0
Australia
Secondary sponsor category [2] 301204 0
Other
Name [2] 301204 0
Holmesglen Institute
Address [2] 301204 0
PO Box 42
HOLMESGLEN
VIC
3148
AUSTRALIA
Country [2] 301204 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302229 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 302229 0
La Trobe University
Kingsbury Drive
Bundoora
3086
Victoria
Ethics committee country [1] 302229 0
Australia
Date submitted for ethics approval [1] 302229 0
20/10/2018
Approval date [1] 302229 0
19/12/2018
Ethics approval number [1] 302229 0
HEC18464

Summary
Brief summary
This NHMRC funded partnership grant project is a Falls Risk Assessment Form (FRAT) dis-investment non-inferiority study and investigates the effects of cessation of a traditional hospital FRAT (currently used in many public and private hospitals Australia-wide) and implementation of an evidence-based procedure where clinicians prioritize mitigating falls. It is predicted that dis-investing from rating falls risk using the traditional FRAT and prioritising clinician judgement about falls mitigation will require less resources to implement and will not lead to worse hospital falls outcomes than the usual care FRAT.
Trial website
Not applicable.
Trial related presentations / publications
None to date
Public notes
None to date

Contacts
Principal investigator
Name 89514 0
Prof Meg Morris
Address 89514 0
La Trobe University
Kingsbury Dr, Bundoora VIC 3086
Country 89514 0
Australia
Phone 89514 0
+61 3 9479 6080
Fax 89514 0
Email 89514 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 89515 0
Mrs Shayne Logue
Address 89515 0
National Capital Private Hospital
Garran ACT 2605
Country 89515 0
Australia
Phone 89515 0
+61 2 6222 6657
Fax 89515 0
Email 89515 0
shayne.logue@healthscope.com.au
Contact person for scientific queries
Name 89516 0
Dr Dana Jazayeri
Address 89516 0
La Trobe University
Kingsbury Dr, Bundoora VIC 3086
Country 89516 0
Australia
Phone 89516 0
+61 404346353
Fax 89516 0
Email 89516 0
d.jazayeri@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be made public due to patient confidentiality.
What supporting documents are/will be available?
Study protocol
Ethical approval
Summary results
No Results