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Trial registered on ANZCTR


Registration number
ACTRN12621000823875p
Ethics application status
Not yet submitted
Date submitted
10/05/2021
Date registered
28/06/2021
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of falls prevention alarms in hospitals by removing or reducing their use
Scientific title
Using disinvestment to investigate the effectiveness of mobilisation alarms in a stepped-wedge randomised trial design in tertiary hospitals
Secondary ID [1] 304184 0
NHMRC Ideas Grant project code: APP1186185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 321881 0
Condition category
Condition code
Injuries and Accidents 319611 319611 0 0
Other injuries and accidents
Public Health 319612 319612 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the elimination or reduction of mobilisation alarms in hospital wards. The use of mobilisation alarms to prevent falls in hospitals have uncertain evidence for their effectiveness, but they are also one of the most frequently used falls prevention strategies that have high costs associated. There will be two arms of intervention:
Arm 1
Total elimination of mobilisation alarms on the ward.
Arm 2
Reduction of mobilisation alarm use to below 3% on the ward.
Eighteen hospital wards will be paired, with one ward in Arm 1 and one ward in Arm 2. The intervention will be administered in a stepped-wedge manner, where all ward pairs begin with usual care, and then begins intervention one pair at a time in a sequential manner on a monthly basis, until all ward pairs are undergoing intervention. The first ward pair will be monitored for 1 month of usual care before beginning intervention. All pairs will stop intervention at the same time, one month after the last pair has began intervention. The first ward pair will have undergone 9 months of intervention, and the last ward pair will have undergone 1 month of intervention.
The total period of intervention will be 9 months. At the end of the 9 months, all wards will be able to return to their previous levels of alarms at their own discretion.
Intervention code [1] 320515 0
Prevention
Intervention code [2] 320516 0
Treatment: Devices
Comparator / control treatment
A control group will be monitored. This will consist of 18 hospital wards that do not have any interventions given regarding their use of mobilisation alarms.
Control group
Active

Outcomes
Primary outcome [1] 327461 0
Rate of falls at each ward measured through daily beside audits across 2-week periods. This will be monitored via patient medical records and nursing reports.
Timepoint [1] 327461 0
At 3 timepoints:
1. Baseline: on month before the trial begins.
2. 1 month after intervention ends (primary timepoint).
3. 12 months after intervention ends.
Secondary outcome [1] 395177 0
Falls-related adverse events defined by any physical harm resulting from a fall, including bruising, abrasions, lacerations, and fractures. This will accessed by electronic patient records and nursing reports.
Timepoint [1] 395177 0
Weekly throughout the 10-month intervention period.
Secondary outcome [2] 395178 0
Patient satisfaction measured by the question "Overall, how would you rate the care you received while in hospital?" Responses include: very good, good, average, poor, very poor.
Timepoint [2] 395178 0
36 hours prior to planned discharge
Secondary outcome [3] 395179 0
Patient sleep quality measured by the Pittsburg Sleep Quality Index
Timepoint [3] 395179 0
36 hours prior to planned discharge
Secondary outcome [4] 395182 0
Cost-effectiveness of the elimination and/or reduction of mobilisation alarms, measured by the incremental cost-effectiveness ratio between the total costing for patient health service utilisation and the impact on falls for usual care, compared to the intervention arms.

The costs will include clinical costings for the inpatient admission on the participating wards and hospital re-admissions within 30 days, falls with serious injuries will have subsequent costs of procedures identified, as well as falls prevention strategies including mobilisation alarms. Clinical costing data will be based on casemix payments to the hospitals. The effect will include the impact on falls (falls avoided/additional falls).
Timepoint [4] 395182 0
Baseline and throughout the 10-month period of the intervention.
Secondary outcome [5] 395183 0
Cost-benefits of the elimination and/or reduction of mobilisation alarms, measured by a cost-benefit analysis to determine the net-benefit of intervention.

The cost of implementation will be reported across the six participating health services. Implementation activities will include activities such as meetings, policy design, evidence reviews, staff education time and materials, patient and family education materials, marketing and communication materials, as well as costs associated with mobilisation alarms and other falls strategies already in place or introduced as a response to reducing or eliminating mobilisation alarms. This will exclude direct research activities and resources. Each of the resources will be reported in natural units and valued at market rate. Staff time will be costed using the relevant current Victorian EBA as an hourly rate with 25% health service on-costs applied.

The benefit to be measured is the direct patient cost data reported for the cost-effectiveness analysis.
Timepoint [5] 395183 0
Baseline and throughout the 10-month period of intervention, 1 month after end of intervention.
Secondary outcome [6] 395185 0
Proportion of hospital wards with mobilisation alarm use rate of higher than 3%, measured through daily bedside audits across 2-week periods
Timepoint [6] 395185 0
Baseline (one month before intervention begins for first ward pair), 1 month after intervention ends, 12 months after intervention ends.
Secondary outcome [7] 395190 0
Rate of newly developed pressure injuries. measured via hospital records and nursing notes.
Timepoint [7] 395190 0
Throughout the 10-month intervention period.
Secondary outcome [8] 395191 0
Rate of use of other falls prevention interventions, including falls risk signage, bedside commode, call button within reach, bed sitter, ambulatory aid accessible from bed, regular bed in low position, specialty low position bed, locked bed, anti-slip floor mat, physical restraint, non-slip socks, non-skid footwear. These will be measured by weekly audits of hospital wards. This will be a composite measure assessed in unison.
Timepoint [8] 395191 0
Baseline, throughout the 10-month intervention period, 1 month and 12 months after intervention.
Secondary outcome [9] 395192 0
Staff acceptance of the intervention, measured by qualitative interviews conducted with ward staff. Interviews will be conducted in a group setting with all staff from the same ward in the same interview. The interviews will be semi-structured, guided by specific questions about staff attitudes and experiences. These will be audio-recorded for later analysis.
Timepoint [9] 395192 0
Baseline, one week before intervention begins, 1 month after intervention ends, 12 months after intervention ends.
Secondary outcome [10] 396562 0
Rate of 30-day hospital readmission, measured via hospital records and nursing notes.
Timepoint [10] 396562 0
Throughout the 10-month intervention period.
Secondary outcome [11] 397481 0
Rate of medication errors. This will accessed by electronic patient records and nursing reports.
Timepoint [11] 397481 0
Weekly throughout the 10 month intervention period.

Eligibility
Key inclusion criteria
Hospital wards with a minimum mobilisation alarm use rate of 3% .
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hospital wards in the categories of emergency, mental health, palliative care, and paediatric care, will be excluded.
2. Hospital wards that have less than 20 beds will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each ward will be first provided wit a pseudonym. A researcher who is blind to ward identity will conduct the randomisations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The design requires two stages of randomisation:
1) The first to allocate each ward pair to a particular time period for beginning intervention. A computer-generated random number sequence will be used for the first stage.
2) The second stage of randomisation will split each pair to either of the eliminated or reduced mobilisation alarm intervention arms. Frane's dynamic randomisation approach will be adapted for this. The first 3 pairs will be randomised using computer generated numbers. After this, ward pairs will be temporarily split in both possible ways, and a mixed-methods analysis using all available falls rate data from the “Current” condition period will be undertaken with allocation status (“Reduced” or “Eliminated”) as the independent variable of interest. The allocation approach that has the highest p-value from the two analyses will then be adopted. This will be repeated for each subsequent ward pair.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
While this will be a parallel intervention study, the time span of intervention will be different for each cluster (ward pair) due to the stepped-wedge design.
Pair 1: 1 month of usual care, 9 months of reduction and elimination.
Pair 2: 2 months of usual care, 8 months of reduction and elimination.
Pair 3: 3 months of usual care, 7 months of reduction and elimination.
Pair 4: 4 months of usual care, 6 months of reduction and elimination.
Pair 5: 5 months of usual care, 5 months of reduction and elimination.
Pair 6: 6 months of usual care, 4 months of reduction and elimination.
Pair 7: 7 months of usual care, 3 months of reduction and elimination.
Pair 8: 8 months of usual care, 2 months of reduction and elimination.
Pair 9: 9 months of usual care, 1 month of reduction and elimination.
The total period of intervention will be 10 months, with all ward pairs ending intervention at the same time.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We assumed a mean (sd) baseline (“Current” condition) rate of falls per ward-month period of 8 and an ICC of 0.6 based on previous research. We randomly generated data meeting these requirements for 1000 stimulated replications of this design. We then randomly sampled with replacement individual studies from this pool 1000 times. We varied the possible impact of the “Reduced” and “Eliminated” conditions in these simulations to estimate the detectable difference to achieve 80% of simulations rejecting the null hypothesis at a 95% confidence level in the planned one-tailed non-inferiority analyses and two-tailed superiority analyses. This study will involve 18 hospital wards, each observed over 10 ward-month (calendar month) time periods.

Non-inferiority analyses and superiority analyses will be conducted to compare the number of falls between interventions and usual care, and the between the two intervention arms. Margins were calculated for each analysis to allow judgement of non-inferiority and/or superiority.

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)
VIC

Funding & Sponsors
Funding source category [1] 308561 0
Government body
Name [1] 308561 0
National Health and Medical Research Council
Address [1] 308561 0
414 La Trobe St, Melbourne, Victoria, 3000
Country [1] 308561 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University Peninsula Campus
Moorooduc Highway
Frankston
Victoria, 3199
Country
Australia
Secondary sponsor category [1] 309421 0
None
Name [1] 309421 0
Address [1] 309421 0
Country [1] 309421 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308503 0
Monash Health Human Research Ethics Committee A (EC00382)
Ethics committee address [1] 308503 0
Level 2, i Block
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Ethics committee country [1] 308503 0
Australia
Date submitted for ethics approval [1] 308503 0
01/07/2021
Approval date [1] 308503 0
Ethics approval number [1] 308503 0

Summary
Brief summary
Mobilisation alarms are a staple in hospitals to prevent falls, but there is uncertain evidence for their effectiveness and they can take up to 11% of all falls prevention management costs. This study aims to produce definitive evidence for their effectiveness. Selected hospital wards will remove or reduce their mobilisation alarms, and the rate of falls and falls-related outcomes will be measured and compared to hospital wards that continue to use the alarms as usual. It is hypothesised that removing or reducing mobilisation alarms will not lead to an increase in falls and falls-related injuries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110934 0
Prof Terry Haines
Address 110934 0
Level 3, Building G
Monash University Peninsula Campus
47-49 Moorooduc Highway
Frankston
Victoria, 3199
Country 110934 0
Australia
Phone 110934 0
+61 03 99029409
Fax 110934 0
Email 110934 0
terry.haines@monash.edu
Contact person for public queries
Name 110935 0
Dr Debbie Pu
Address 110935 0
Level 3, Building G
Monash University Peninsula Campus
47-49 Moorooduc Highway
Frankston
Victoria, 3199
Country 110935 0
Australia
Phone 110935 0
+61 03 99044004
Fax 110935 0
Email 110935 0
debbie.pu@monash.edu
Contact person for scientific queries
Name 110936 0
Prof Terry Haines
Address 110936 0
Level 3, Building G
Monash University Peninsula Campus
47-49 Moorooduc Highway
Frankston
Victoria, 3199
Country 110936 0
Australia
Phone 110936 0
+61 03 99029409
Fax 110936 0
Email 110936 0
terry.haines@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the study, deidentified.
When will data be available (start and end dates)?
Immediately after publication, no end date.
Available to whom?
Researchers who provide a methodologically sound proposal, as judged by the chief investigator and primary sponsor.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Chief Investigator, Prof. Terry Haines (terry.haines@monash.edu)
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 11643 0
Study protocol
Citation [1] 11643 0
Link [1] 11643 0
Email [1] 11643 0
debbie.pu@monash.edu
Other [1] 11643 0
Attachment [1] 11643 0
Summary results
No Results