Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000200189
Ethics application status
Approved
Date submitted
5/02/2019
Date registered
12/02/2019
Date last updated
22/03/2021
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing hospital falls by optimal screening: Educating health professionals
Scientific title
Educating health professionals to optimise falls screening in hospitals
Secondary ID [1] 297296 0
Nil known
Universal Trial Number (UTN)
U1111-1228-0041
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 311379 0
Condition category
Condition code
Public Health 310017 310017 0 0
Health service research
Injuries and Accidents 310047 310047 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two participant cohorts receiving an education intervention
Cohort 1:
The researchers will provide a three-hour education program at each intervention hospital, to consenting clinical leaders, using best educational design. This will educate clinical leaders on the latest evidence on hospital falls risk assessment and guide them in how to implement a new falls screening form (Form B) that eliminates a traditional checklist risk assessment approach. The education intervention will also gauge participants’ views on the old Falls Risk Assessment Tool (FRAT) form (Form A) compared to the new form (Form B).
Furthermore, participants in cohort 1 will be provided with the practical skills to enable them to deliver an effective, one-hour in-service training session on the use of the new falls screening form, to nurses and allied health professionals, who are involved in completing the new tool. They will be taught the education program methods and will be given a standard lesson plan with all associated educational resources.

Cohort 2:
The second cohort will consist of all consenting nurses and allied health professionals involved in completing falls screening forms at participating hospitals. They will attend a one-hour in-service training and be taught the education intervention by the clinicians who were in cohort 1.

Methods of educational delivery will include:
• interactive face-to face teaching
• content delivery on the latest evidence for falls risk assessment
• role-play simulated exercises
• critical thinking activities from video-recordings of simulated patients showing a range of falls related clinical vignettes
• content delivery and practice activities on how to use the new form, how to progress immediately to the falls mitigation components of the form, and how to spend the time saved on falls prevention

The study will be based on a Pre and Post-test design, elaborated through a mixed methods research approach. Data will be collected via de-identified surveys (using the participants’ initials and last three digits of their mobile telephone number) and individual telephone interviews. Multiple time points will be used for data collection from surveys:
Pre-test: Immediately prior to the education program (paper-based survey)
Post-test 1: Immediately post the education program (paper-based survey)
Post-test 2: Two months post implementation of the new screening tool (electronic survey)

Paper-based surveys will be collected by those who deliver the education program. For cohort 2, all surveys will be returned to researchers via registered post.
Intervention code [1] 313545 0
Behaviour
Comparator / control treatment
Usual care. For hospitals/clinicians in the control group, the historical Falls Risk Screening Tool (Form A) will continue to be used to assign a falls risk score to patients, and corresponding fall prevention management strategies will continue according to usual care. They will not receive any new education beyond usual processes.
Control group
Active

Outcomes
Primary outcome [1] 318920 0
Primary outcome 1: Conceptual and behavioural change from the existing FRAT (Form A)

The Pre-test Survey asks participants to select a single statement from a list of 5 to identify their view on the current FRAT form.

The Post-test 1 Survey repeats the 5-item statement to identify participants’ views on the forms and determine if there have been any changes.

Post-test 2 Survey repeats the items from Post-test 1. Three open-ended questions are asked about whether they believe the new form has been beneficial to patients and to them personally.

Semi-structured telephone interviews will be conducted post implementation with consenting participants randomly selected from two randomly chosen experimental sites, in order to triangulate the data from the questionnaires and to allow staff to state confidentially their thoughts on the changes to the falls screening forms. From cohort 1, one health professional will be invited to participate. Cohort 2 interviewees invited to participate will consist of two other randomly selected staff - a junior staff member (qualified three years or less), and a senior staff member (qualified more than three years). Telephone Interviews will be audio-recorded for transcription purposes, and to ensure clarity and accuracy.
Timepoint [1] 318920 0
Pre-intervention, immediately post intervention, two months post intervention
Primary outcome [2] 318921 0
Change in knowledge of evidence-based practice for falls screening and prevention in hospitals.

The Pre-test Survey asks participants to rate 20 statements regarding evidence-based practice falls risk assessment on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Free text comments are invited at the conclusion of the survey.

Post-test Surveys 1 and 2 repeat the items from the pre-test survey on evidence-based practice and falls risk assessment with minor changes to 6 items and the addition of 4 new items (1 item is removed).
Timepoint [2] 318921 0
Pre-intervention, immediately post intervention, two months post intervention
Primary outcome [3] 319024 0
Primary Outcome (3): Provide clinical leaders in cohort 2 with the skills to enable them to deliver an effective education program to other clinicians.

Post-test 1 Survey for cohort 2 participants, asks questions around how prepared and confident they feel in educating others. The 9 items are from a previously validated Instructional Material Motivation Survey. The relevance subscale from this survey is the only section to be used, as it has the most applicability. Post-test 1 Survey includes 5 items seeking participants’ perceptions of the overall learning experience rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Participants are asked if they think the workshop was an effective way to be taught about the new Falls Screening tool. Three open ended questions are included asking participants to comment on what worked well in the workshop, what needs improvement and their views on the ‘take home’ messages from the workshop.
Timepoint [3] 319024 0
Immediately post intervention
Secondary outcome [1] 366427 0
Outcomes from the education program, to inform the future refinement of educational delivery across hospital sites.

Post-test 1 Survey includes 5 items seeking participants’ perceptions of the overall learning experience rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
Timepoint [1] 366427 0
June 2019
Secondary outcome [2] 366751 0
Secondary outcome (2): Costs of time 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 [2] 366751 0
June 2019

Eligibility
Key inclusion criteria
Cohorts 1 and 2 will be drawn from all hospital wards (except paediatric, maternity, emergency and theatre wards) in the experimental group hospitals.
Cohort 1 -10 clinical leaders to be approached to consider participating in the study; Cohort 2 - All nurses and allied health professionals involved in completing falls screening forms.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
paediatric, maternity, emergency and theatre wards; non-clinical staff

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospitals will be randomised by another organisation to either (1) continuing to use the current FRATA 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 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

In the experimental group hospitals for cohort 1: Hospital General Managers will provide 10 clinical leaders to be approached to consider participating in the study. These clinical leaders will be invited to participate via email, which will contain all details about the study. The email will also provide the clinical leaders with the Participant Information and Consent Form. For cohort 2, all nurses and allied health professionals involved in completing falls screening forms will be invited to participate in the study by the quality managers at each experimental site, via email. Participants will be drawn from all wards in the five experimental hospitals, excluding paediatric, maternity, emergency and theatre wards. The Pre-test Survey identifies demographic characteristics of the sample such as profession, position, years of clinical practice experience, gender and location of work.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study is a cluster randomised control trial where hospitals are randomised to group A or group B.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data: Using SPSS, demographic data and responses on all Likert scaled surveys and rating scales, will be analysed descriptively. Paired samples t-test will compare responses within the participant group to see if there is a significant difference between mean scores at Pre-test, Post-test 1 and Post-test 2. Comparisons between groups will be measured according to profession, years of clinical practice, and hospital site.
We will determine whether the education intervention resulted in a statistically significant conceptual change to the new form, and whether the educational intervention requires further development in terms of content and delivery.
Qualitative responses from surveys and telephone interviews will undergo content and thematic analysis checking for commonality of themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2019
Actual
26/02/2019
Date of last participant enrolment
Anticipated
31/05/2019
Actual
28/02/2020
Date of last data collection
Anticipated
1/09/2019
Actual
28/02/2020
Sample size
Target
250
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
ACT,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 301859 0
Government body
Name [1] 301859 0
National Health and Medical Research Council
Country [1] 301859 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Dr, Bundoora, Vic 3086
Country
Australia
Secondary sponsor category [1] 301603 0
Commercial sector/Industry
Name [1] 301603 0
Healthscope
Address [1] 301603 0
1/ 312 St Kilda Rd, Melbourne Vic 3004
Country [1] 301603 0
Australia
Secondary sponsor category [2] 301608 0
Commercial sector/Industry
Name [2] 301608 0
Holmesglen Institute
Address [2] 301608 0
PO Box 42, Holmesglen, Vic 3148
Country [2] 301608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302553 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 302553 0
Ethics committee country [1] 302553 0
Australia
Date submitted for ethics approval [1] 302553 0
12/11/2018
Approval date [1] 302553 0
23/01/2019
Ethics approval number [1] 302553 0
HEC18501

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

Contacts
Principal investigator
Name 90626 0
Prof Meg Morris
Address 90626 0
La Trobe University, Kingsbury Dr, Bundoora, Vic 3086
Country 90626 0
Australia
Phone 90626 0
+61 3 9479 6080
Fax 90626 0
Email 90626 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 90627 0
Shayne Logue
Address 90627 0
National Capital Private Hospital, Garran, ACT 2605
Country 90627 0
Australia
Phone 90627 0
+61 2 6222 6657
Fax 90627 0
Email 90627 0
Shayne.logue@healthscope.com.au
Contact person for scientific queries
Name 90628 0
Louise Shaw
Address 90628 0
La Trobe University, Kingsbury Dr, Bundoora, Vic 3086
Country 90628 0
Australia
Phone 90628 0
+61 426968873
Fax 90628 0
Email 90628 0
louise.shaw@latrobe.edu.au

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 of the individual data collected during the trial, after de-identification. Data will be from survey responses and responses from semi-structured telephone interviews.
When will data be available (start and end dates)?
01/ 03/ 2019 - 31/ 05/ 2019
Available to whom?
Researchers on the study 'Educating health professionals to optimise falls screening in hospitals'.
Available for what types of analyses?
Using SPSS, demographic data and responses on all Likert scaled surveys and rating scales, will be analysed descriptively. Paired samples t-test will compare responses within the participant group to see if there is a significant difference between mean scores at Pre-test, Post-test 1 and Post-test 2. Comparisons between groups will be measured according to profession, years of clinical practice, and hospital site.
We will determine whether the education intervention resulted in a statistically significant conceptual change to the new form, and whether the educational intervention requires further development in terms of content and delivery.
Qualitative responses from surveys and telephone interviews will undergo content and thematic analysis checking for commonality of themes.
How or where can data be obtained?
Access subject to approvals by Principal Investigator; all who access will be required to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1293Study protocol    376892-(Uploaded-25-07-2019-10-48-10)-Study-related document.docx
1294Informed consent form    376892-(Uploaded-05-02-2019-12-37-59)-Study-related document.docx
1295Informed consent form    376892-(Uploaded-05-02-2019-12-38-27)-Study-related document.docx
1296Ethical approval    The following project has been assessed as complyi... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEducating health professionals to optimise falls screening in hospitals: protocol for a mixed methods study.2020https://dx.doi.org/10.1186/s12913-020-4899-y
N.B. These documents automatically identified may not have been verified by the study sponsor.