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Trial registered on ANZCTR


Registration number
ACTRN12617000314325
Ethics application status
Approved
Date submitted
21/02/2017
Date registered
28/02/2017
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does abbreviating patient falls risk screening in documentation impact on falls in hospital inpatients: A stepped wedge cluster randomised control trial
Scientific title
Does abbreviating patient falls risk screening in documentation impact on falls in hospital inpatients: A stepped wedge cluster randomised control trial
Secondary ID [1] 291117 0
None
Universal Trial Number (UTN)
U1111-1193-3403
Trial acronym
Short FRAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 301947 0
Condition category
Condition code
Injuries and Accidents 301598 301598 0 0
Other injuries and accidents
Public Health 301599 301599 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The traditional Falls Risk Assessment Tool (FRAT) is currently used for all inpatient admissions to rate the falls risk of patients prior to initiating falls prevention interventions. It guides the user to firstly rate the risk of falls through a series of questions 7 questions which asks the user to score on a scale of 1-4 or low, medium or high. This research will remove this tool and therefore remove the rating scores for patients.

The short FRAT will be a template which guides the user to falls intervention strategies only, The user will be asked if the person had a recent fall, change in cognition or decline in mobility. A yes to any answer will trigger the use of strategies targeted to the individual need to the patient.
Patient focused falls interventions will be documented on a Short FRAT based on observed and personalised need rather then the risk level.
Intervention code [1] 297241 0
Early detection / Screening
Comparator / control treatment
The control group will be patients on other wards who continue to be exposed to the traditional FRAT use on admission and during hospital stay.
Control group
Active

Outcomes
Primary outcome [1] 301166 0
Rate of falls per 1000 occupied bed days will be obtained through a generated report from the local Victorian health incident management system for all intervention and control wards.
Timepoint [1] 301166 0
10 months
Secondary outcome [1] 331933 0
Rate of falls resulting in serious injury or death (Serious injury defined as major injury requiring surgery, casting, further examination e.g., for a neurological injury) will be obtained through a generated report from the local Victorian health incident management system for all intervention and control wards.
Timepoint [1] 331933 0
10 months
Secondary outcome [2] 331934 0
Estimate of change in time taken to complete traditional and short FRAT (nurse report)
Timepoint [2] 331934 0
10 months
Secondary outcome [3] 331935 0
Estimated FRAT documentation completions through compliance audits of files of intervention and control wards
Timepoint [3] 331935 0
10 months
Secondary outcome [4] 331936 0
Estimate of the number of interventions provided in category within the new and old forms through random audits of intervention and control wards
Timepoint [4] 331936 0
10 months

Eligibility
Key inclusion criteria
All patients who are admitted to intervention wards at Peninsula Health
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non inclusion of paediatric and maternity 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)
No allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the 9 ward clusters will be conducted 4 weeks prior to the start of the study using a computer-generated number sequence an investigator not involved in service model change. The allocation is then communicated to the chief investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The design of this trial is a roll-in stepped wedge cluster randomised trial as described by Haines, T, O'Brien, L, McDermott, F, Markham, D, Mitchell, D, Watterson, D, and Skinner, E (2013). A pragmatic approach has been taken to the ward clusters based on best size, location in the hospital and flow of patients.

The clusters have been grouped as:
1. The Mornington Centre (3 wards)
2. Rosebud Hospital (2 wards)
3. Gold Links Road Hospital (2 wards)
4. All wards on Level 5 of Frankston hospital
5. Bass/Westernport/Port Phillip wards at Frankston Hospital
6. Mental Health wards at Frankston Hospital
7. Short stay and evaluative medical wards at Frankston Hospital
8. Palliative Care at Golf Links Road
9. Intensive care at Frankston Hospital.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. The primary analyses will compare between intervention (New FRAT) and control (traditional FRAT) periods in the rate of falls (falls per 1000 patient days) using negative binomial regression and the proportion of patients who experience one or more falls versus no falls using logistic regression and the rate of falls resulting in injury using negative binomial regression. Each analysis will use patient-level data that will be clustered within ‘unit’.

Only data from patients admitted following the start of trial will be included, and the data will be censored at trial conclusion for patients remaining on the units after this point. Patients already admitted to the units at the point where the unit transitions from being a control unit to an intervention unit will have their data censored from the day prior to the start of transition. This is to avoid contamination of data analyses by patients who are exposed to control and intervention periods on their unit.

Secondary analyses will be determined with regression analysis to determine any difference between groups.

We have based the power analysis on the detailed falls data collected as part of the STOP-Falls trial. If we assume that the intervention will have an effect of the incidence rate of falls 0.7 (reduction of 30% by increasing targeted interventions)

This trial will have 70% power to detect a 30% reduction in the rate of falls given the design parameters of 9 clusters (streams) that are randomised, and a two-tailed alpha=0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
4/12/2017
Actual
1/01/2018
Date of last data collection
Anticipated
1/01/2018
Actual
31/01/2018
Sample size
Target
16000
Accrual to date
Final
15210
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7534 0
Frankston Hospital - Frankston
Recruitment hospital [2] 7535 0
Rosebud Hospital - Rosebud
Recruitment hospital [3] 7536 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment hospital [4] 7537 0
The Mornington Centre - Mornington
Recruitment postcode(s) [1] 15359 0
3199 - Frankston
Recruitment postcode(s) [2] 15360 0
3939 - Rosebud
Recruitment postcode(s) [3] 15361 0
3931 - Mornington

Funding & Sponsors
Funding source category [1] 295556 0
Hospital
Name [1] 295556 0
Peninsula Health
Country [1] 295556 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
2 Hastings Rd,
Frankston VIC, 3199
Country
Australia
Secondary sponsor category [1] 294377 0
University
Name [1] 294377 0
Monash University
Address [1] 294377 0
McMahons Rd,
Frankston, VIC, 3199
Country [1] 294377 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296877 0
Peninsula Health
Ethics committee address [1] 296877 0
Ethics committee country [1] 296877 0
Australia
Date submitted for ethics approval [1] 296877 0
01/02/2017
Approval date [1] 296877 0
28/03/2017
Ethics approval number [1] 296877 0
LRR/17/PH/1
Ethics committee name [2] 298147 0
Monash University
Ethics committee address [2] 298147 0
Ethics committee country [2] 298147 0
Australia
Date submitted for ethics approval [2] 298147 0
10/05/2017
Approval date [2] 298147 0
10/05/2017
Ethics approval number [2] 298147 0
2017 - 9377

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

Contacts
Principal investigator
Name 72306 0
Dr Cylie Williams
Address 72306 0
Peninsula Health
Level 3 - Office for Research
2 Hastings Rd,
Frankston VIC 3199
Country 72306 0
Australia
Phone 72306 0
+61 3 9784 2678
Fax 72306 0
Email 72306 0
cyliewilliams@monash.edu
Contact person for public queries
Name 72307 0
Joanna Jellett
Address 72307 0
Peninsula Health
2 Hastings Rd,
Frankston VIC 3199
Country 72307 0
Australia
Phone 72307 0
+61 3 5976 9165
Fax 72307 0
Email 72307 0
JJellett@phcn.vic.gov.au
Contact person for scientific queries
Name 72308 0
Cylie Williams
Address 72308 0
Peninsula Health
Level 3 - Office for Research
2 Hastings Rd,
Frankston VIC 3199
Country 72308 0
Australia
Phone 72308 0
+613 9784 2678
Fax 72308 0
Email 72308 0
cyliewilliams@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.