Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000817549
Ethics application status
Approved
Date submitted
27/07/2015
Date registered
10/08/2015
Date last updated
20/01/2020
Date data sharing statement initially provided
20/01/2020
Date results provided
20/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing the effectiveness, cost-effectiveness and student experience of simulation training for the prevention of falls amongst hospitalised inpatients
Scientific title
Does training heath professional students on hospital placements with falls prevention simulation reduce inpatient falls?
Secondary ID [1] 286723 0
Nil
Universal Trial Number (UTN)
Trial acronym
STOP-Falls: Simulation Training On Prevention of FALLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 295086 0
Condition category
Condition code
Injuries and Accidents 295336 295336 0 0
Other injuries and accidents
Public Health 296045 296045 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health professional students undertaking placement within the intervention wards will attend a 4 hour training session within the first 7 days of their placement or at the commencement of each trial period in 2015 and 2016 (if the student is mid placement). Each trial period is 16 weeks with a wash out of period of 14 weeks.

The simulation training (intervention) will delivered by health professionals (Nurse and Speech Pathologist) who are experienced in simulated learning theory and tutoring. The same simulated patient actors will be used throughout the training periods. The intervention encompasses falls prevention training in the safe recovery program and management of patients with delirium or dementia in order to reduce or prevent falls.

Educational techniques to be employed will include video lecture, video based case modeling, facilitated discussions, and high fidelity simulation using an actor portraying a role of a hospital patient at risk for falls. Attendance records of students will be kept for the stimulation training sessions. There will be a new cohort of students in 2016 therefore ensuring full intervention wash out.
Intervention code [1] 291882 0
Behaviour
Intervention code [2] 291944 0
Prevention
Comparator / control treatment
The control condition will be usual care practices without any additional training in falls prevention for health professional students undertaking placements in these work environments. There is currently no formal falls prevention training offered to students. Orientation to falls risk status tools is undertaken as part of orientation to health records.
Control group
Active

Outcomes
Primary outcome [1] 295086 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 intervention wards in addition to information collected during week day attendance at nursing handover.
Timepoint [1] 295086 0
There will be two x 16 week periods of falls data collection across participating wards.
Primary outcome [2] 295141 0
Proportion of patients who experience 1 or more falls will be obtained through a generated report from the local Victorian health incident management system for intervention wards in addition to information collected during week day attendance at nursing handover.
Timepoint [2] 295141 0
There will be two x 16 week periods of falls data collection across participating wards.
Primary outcome [3] 295142 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 intervention wards in addition to information collected during week day attendance at nursing handover.

Timepoint [3] 295142 0
There will be two x 16 week periods of falls data collection across participating wards.
Secondary outcome [1] 314731 0
Knowledge gain of undergraduate students who have undertaken the falls prevention simulation training will be measured thorough a custom developed survey tool.
Timepoint [1] 314731 0
End of simulation training.
Secondary outcome [2] 314733 0
Cost of acute / rehabilitation care measured using clinical costing data for all patients on intervention and non-intervention wards.
Timepoint [2] 314733 0
There will be two x 16 week periods of falls data collection across participating wards.
Secondary outcome [3] 314846 0
Length of stay of every patient on the intervention and non-intervention wards through data extraction from hospital records
Timepoint [3] 314846 0
There will be two x 16 week periods of falls data collection across participating wards.
Secondary outcome [4] 314847 0
Self rated student confidence to engage in falls prevention activities and discussions with patients will be measured thorough a custom developed survey tool.
Timepoint [4] 314847 0
There will be two data collection time points for each student, post simulation and post student placement.
Secondary outcome [5] 314848 0
Self reported frequency of falls prevention engagements between student and patient will be measured thorough a custom developed survey tool.
Timepoint [5] 314848 0
Post student placement.
Secondary outcome [6] 316292 0
Learner experience of simulation training and the experience of undertaking falls prevention activities on intervention wards will be gathered through indepth semi-structured student interviews
Timepoint [6] 316292 0
Post student placement.

Eligibility
Key inclusion criteria
Group 1
- All health professional undergraduate students from Monash University attending placement at Peninsula Health for at least two weeks or more.
- Placement on wards which have been randomized to the
intervention or control.

Group 2
Patients admitted to intervention wards within PH
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1 - Nil, all students will be included within the training and due to placement structures, will be placed on non-included wards for any subsequent ward placements in the second 16 week period.
Group 2 - Non inclusion of intensive care, paediatric, maternity or palliative care 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)
Group 1
All students who are allocated to an intervention ward will participate in falls prevention simulation training as scheduled part of orientation to their placement. At this time, the student will also be consented to the collection of anonymous data about their experience with the simulation training, their knowledge of falls prevention and evidence supporting falls prevention initiatives. This enrollment will be face to face by the tutors of the simulation training and member of the research team.

In order to ascertain the quality of the simulation education / intervention and learner experience, purposively sampled participants’ experiences will be documented through in-depth interview. Students who have participated in the training will be invited to express an interest in participating in an interview to further describe the impact of falls prevention simulation training on their placement.

All students who are allocated to a control ward will also be contacted via email from the student coordinators of Peninsula Health at the end of the placement. They will be offered a survey on their knowledge of falls prevention and evidence supporting falls prevention initiatives.

Group 2
There will be random allocation of 8 health service streams/wards to either a “simulation education / intervention” condition, or a “no education / control” condition. There will be a 16 week data collection period in August-December 2015, a wash-out period over the January 2016 and another 16 week data collection period from March 2016. The second data collection period will reverse the intervention / control allocation status of each stream so that each stream will have one 16 weeks control period and one 16 week intervention period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The health care streams/wards will be matched into pairs on the basis of number of student days within the stream/wards. One stream/wards within each pair will then be randomly allocated to the group that receives the simulated training in 2015, while the remaining member of the pair will receive the simulated training in 2016. The primary investigator will send paired mock codes linked to each stream/ward to a separate investigator who will use the Microsoft Excel “RANDBETWEEN” command to allocate the mock codes to each group. These allocations will then be sent back to the primary investigator so that the allocations to streams can be revealed. The data extractor and investigators undertaking analysis will be blinded to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
This will be a cluster crossover RCT with a 14 week wash out period.

The trial will include 8 streams/wards.
1. Rehabilitation A
2. Rehabilitation B
3. Neuro/Stroke
4. Ortho/Plastics
5. Gastro/General Medical
6. Cardiology
7. Respiratory/Renal
8. Oncology/Endocrinology
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The rate of falls will be compared between intervention and control periods using multi-level, generalised linear models treating patient and health service stream as a random effects, the intervention as a fixed effect. Adjustment for falls rates within each health service area over the previous 2 years will be undertaken. Fall and injury rates will be examined using a negative binomial distribution, while the proportion of patients who become fallers will be examined using a Bernoulli distribution. We will follow currently held recommendations for analysis of cross-over trials that contain wash-out and not statistically test for cross-over effects. Sensitivity analyses will be conducted excluding patients who represented to hospital during the data collection period and appeared on both intervention and control wards.

Secondary outcomes will also be compared between intervention and control periods using a similar approach. Quantitative student knowledge, skills and attitude outcomes will be compared between groups using end-of-placement assessments, and within the intervention group using pairwise contrasts between pre-, immediate post-intervention, and end-of-placement assessments.

Qualitative data will be analysed thematically. The relationship between the interviewer and interviewees will be noted and documented at the time of the interview and considered during analysis. Researcher reflexivity will be documented. Strategies to achieve trustworthiness of data will be implemented.

The economic evaluation will calculate the incremental cost per fall prevented from using the falls prevention simulation learning package. Costs to be included will be the labour and capital costs of providing the education program to students and patients, and costs of health care provision (clinical costing data).

Decision-tree analytic modelling will be used to conduct a net benefit analysis based on previously developed estimates of the cost of falls in hospitals. Subgroup sensitivity analyses will be conducted for acute and subacute wards.


Primary sample size (8 wards) was calculated against streams.
Conventional power analysis formulae have not previously been developed for this multi-level, cross-over design. We have therefore used a conservative cluster trial power analysis approach that considers only cluster (stream) level data. Individual-level falls data is normally considered to be count data analysed using a negative binomial distribution. However, this data takes on Gaussian-like properties when it is merged across patients within streams over monthly periods. Treating stream-level outcomes as continuous and using a stream-level approach allows us to estimate sample size requirements for our study. We have calculated the sample size requirements for a conventional randomised trial that has a baseline fall rate of 7.2 falls per month per stream, a standard deviation between streams of 6.7, a standard deviation within streams of 3, a correlation of r=0.7 for monthly falls measurements within a stream, and 4 monthly follow-up measures per stream. This identified that 42 clusters per group (84 clusters in total) were required when using an ANCOVA analysis approach adjusting for pre-trial data. We then applied the cross-over design efficiency conversion factor of 12 to find that 8 clusters in total were required for equivalent power in a cross-over design (acknowledging that the total number of monthly trial measurements per cluster needs to be doubled from 4 to 8 per stream). The design efficiency conversion factor calculation formula used was DE = (between stream variance+ within stream variance)/(0.5 * within-stream variance) where between stream variance = 44.89 and the within stream variance = 9 falls per month based on the past 2 years of local data.

Student sample size (400 students) was determined from allocation of students to wards over the two intervention/control periods.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2015
Actual
18/08/2015
Date of last participant enrolment
Anticipated
Actual
8/07/2016
Date of last data collection
Anticipated
26/08/2016
Actual
26/08/2016
Sample size
Target
400
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3798 0
Frankston Hospital - Frankston
Recruitment hospital [2] 3799 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment postcode(s) [1] 9688 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 291282 0
Government body
Name [1] 291282 0
Department of Health and Human Services
Country [1] 291282 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
2 Hastings Rd, Frankston, VIC, 3199
Country
Australia
Secondary sponsor category [1] 289957 0
University
Name [1] 289957 0
Monash University
Address [1] 289957 0
McMahons Rd, Frankston VIC 3199
Country [1] 289957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292848 0
Peninsula Health
Ethics committee address [1] 292848 0
Ethics committee country [1] 292848 0
Australia
Date submitted for ethics approval [1] 292848 0
29/05/2015
Approval date [1] 292848 0
11/08/2015
Ethics approval number [1] 292848 0
LRR/15/PH/11

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

Contacts
Principal investigator
Name 57314 0
Dr Cylie Williams
Address 57314 0
Peninsula Health
2 Hastings Rd
Frankston, VIC, 3199
Country 57314 0
Australia
Phone 57314 0
61 3 97842678
Fax 57314 0
Email 57314 0
[email protected]
Contact person for public queries
Name 57315 0
Cylie Williams
Address 57315 0
Peninsula Health
2 Hastings Rd
Frankston, VIC, 3199
Country 57315 0
Australia
Phone 57315 0
61 3 97842678
Fax 57315 0
Email 57315 0
[email protected]
Contact person for scientific queries
Name 57316 0
Terry Haines
Address 57316 0
Monash Health
Allied Health Research Unit
400 Warrigal Rd
Cheltenham, VIC, 3192
Country 57316 0
Australia
Phone 57316 0
+61 3 92658122
Fax 57316 0
Email 57316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.