Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000928718
Ethics application status
Approved
Date submitted
27/06/2022
Date registered
29/06/2022
Date last updated
30/05/2023
Date data sharing statement initially provided
29/06/2022
Date results provided
30/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility, cost and effect of mobilising Allied Health Assistants to prevent hospital falls.
Scientific title
The feasibility, cost and effect of mobilising Allied Health Assistants to prevent hospital falls using patient education alongside usual care.
Secondary ID [1] 307445 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospitalized patients 326812 0
Falls 326813 0
Condition category
Condition code
Injuries and Accidents 324031 324031 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 324032 324032 0 0
Other physical medicine / rehabilitation
Public Health 324043 324043 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- The project team have prepared an evidence-based patient education script on how to prevent falls whilst in hospital, based on their recent meta-analysis of the global literature.
- The project team will train Allied Health Assistant (AHA) staff in how to deliver the falls prevention education script to adult inpatients at a stand alone rehabilitation centre.
- The training will be conducted in face to face small group workshops, facilitated by an allied health professional with expertise in education of clinicians. These training sessions will run for a minimum of three hours, with opportunity for further mentoring and feedback throughout the intervention period. The training will include the use of simulated patients to practice delivery of the education script.
- As close as possible to Day One of hospital admission, patients randomised to the experimental group will be approached by an AHA under the supervision of a registered health professional (nurse, occupational therapist or physiotherapist). The patients will be invited to complete a pre-education survey.
- The AHA will deliver the falls education prevention script to the patients individually, face to face. These sessions will use semi-structured discussion to educate the patient about basic falls prevention whilst in hospital. This discussion will be based on the Falls Prevention Script, in addition to the usual care Falls Prevention Brochure already in use at the hospital. It is anticipated that these discussions will take less than 30 minutes, however the AHA will be guided by the specific needs and context of individual patients.
- Prior to discharge, the patients will be visited by the AHA for an informal discussion around any falls related issues and invited to complete a post-education survey.
- AHA's will be invited to participate in a focus group and in-depth interviews following the intervention, along with the occupational therapists, physiotherapists and nurses involved in supervising the AHA's.
Intervention code [1] 323891 0
Prevention
Intervention code [2] 323892 0
Rehabilitation
Comparator / control treatment
Standard inpatient rehabilitation care. This includes falls risk screening by the nurse admitting the patient and discipline specific initial assessments by occupational therapists and physiotherapists.
Control group
Active

Outcomes
Primary outcome [1] 331821 0
Feasibility of implementing AHA delivered falls education for hospital patients within 48 hours of admission. Feasibility, with respect to fidelity and acceptability, will be assessed qualitatively by AHA report on ease of delivery, supervising clinician report on resources needed to oversee AHA intervention, and feedback from AHA regarding experience of the training sessions, based on focus groups and semi structured one to one interviews. Feasibility will also be quantitatively assessed by recruitment data, where all admitted patients will be randomised and those found to be ineligible will be recorded. Retention will be measured as those eligible and randomised to the experimental group, but did not receive the intervention as a percentage of those eligible who did receive the intervention. Data will be collected from intervention records as to why the intervention did not occur.
Timepoint [1] 331821 0
Data will be collected at the end of the intervention period when the sample size is reached.
Primary outcome [2] 331822 0
Cost of implementation will be assessed by collecting and linking data from medical and study records in addition to costs associated with conducting training sessions.
Timepoint [2] 331822 0
Data will be collected at the end of the intervention period when the sample size is reached.
Primary outcome [3] 331834 0
Falls rates per 1000 bed days of patients in the intervention group compared to patients in the control group.
Timepoint [3] 331834 0
Inpatient falls rates and any associated injuries will be collected at monthly intervals post commencement of the intervention from the hospital adverse events system.
Secondary outcome [1] 411285 0
Patient views and knowledge about hospital falls risks. These will be collected by pre-test and post-test surveys designed specifically for this study. The surveys will be conducted with the experimental group patients only. Each survey is scored with a five-point Likert scale.
Timepoint [1] 411285 0
Baseline (within 48 hours of admission) and within seven days of admission day one.
Secondary outcome [2] 411286 0
Staff views about the usefulness and feasibility of the delivery of the scripted falls prevention education. This data will be collected by both focus groups and semi-structured one to one interviews, conducted by an allied health clinician researcher with expertise in qualitative research methods. Staff invited to focus groups and interviews will include the allied health assistants delivering the intervention and the allied health professionals supervising them (nurses, occupational therapists and physiotherapists).
Timepoint [2] 411286 0
Data will be collected at the end of the intervention period when the sample size is reached.

Eligibility
Key inclusion criteria
For patients:
- Hospital inpatient at the stand alone rehabilitation centre
- Speak, comprehend and read English

For staff:
- AHA staff member who is employed at the rehabilitation centre where the research is taking place
- Willing to volunteer in the research project
Minimum age
18 Years
Maximum age
105 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For patients:
- Medical conditions that impair the ability to listen to, or follow, instructions
- Severe cognitive impairment, dementia or delirium (as documented in the medical record)
- Debilitating pain
- Blind or deaf to the extent that the patient cannot use the falls education brochure
- End of life care or extreme debility arising from conditions such as COVID-19 or severe cancer

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)
Sealed, opaque envelopes stored securely
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence allocation generated using permuted block randomisation with block sizes of 6, 8, or 10 participants long.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Staff are advised to continue all standard care activities throughout trial irrespective of group allocation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility data will be summarized descriptively. Changes in patient levels of knowledge pre and post intervention will be evaluated using non-parametric analyses. Falls data will be compared between intervention and control groups using negative binomial regression. Frequency counts of the proportion of people falling and descriptions of accompanying injuries and the injurious falls rate will be described.

Qualitative focus group and interview data will be recorded and transcribed verbatim, then imported to Word files for data management and analysis. The coding framework will be developed through discussion between researchers, clinicians and consumer representatives based on readings of the interview data. The major themes will be identified through a process of iterative refinement during the different stages of coding. The codes will be used to identify key themes regarding barriers and facilitators to implementing patient falls prevention education.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/12/2022
Actual
18/12/2022
Date of last data collection
Anticipated
8/12/2022
Actual
31/01/2023
Sample size
Target
600
Accrual to date
Final
541
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22635 0
The Victorian Rehabilitation Centre - Glen Waverley
Recruitment postcode(s) [1] 37909 0
3150 - Glen Waverley

Funding & Sponsors
Funding source category [1] 311714 0
University
Name [1] 311714 0
La Trobe University
Country [1] 311714 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road
Bundoora
VIC
3086
Country
Australia
Secondary sponsor category [1] 313172 0
None
Name [1] 313172 0
Address [1] 313172 0
Country [1] 313172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311165 0
La Trobe University Human Ethics Research Committee
Ethics committee address [1] 311165 0
Ethics committee country [1] 311165 0
Australia
Date submitted for ethics approval [1] 311165 0
03/02/2022
Approval date [1] 311165 0
11/05/2022
Ethics approval number [1] 311165 0
HEC21429

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

Contacts
Principal investigator
Name 120178 0
Prof Meg Morris
Address 120178 0
La Trobe University
Plenty Road
Bundoora
VIC
3086
Country 120178 0
Australia
Phone 120178 0
+61 0433405662
Fax 120178 0
Email 120178 0
[email protected]
Contact person for public queries
Name 120179 0
Meg Morris
Address 120179 0
La Trobe University
Plenty Road
Bundoora
VIC
3086
Country 120179 0
Australia
Phone 120179 0
+61 0433405662
Fax 120179 0
Email 120179 0
[email protected]
Contact person for scientific queries
Name 120180 0
Meg Morris
Address 120180 0
La Trobe University
Plenty Road
Bundoora
VIC
3086
Country 120180 0
Australia
Phone 120180 0
+61 0433405662
Fax 120180 0
Email 120180 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
Data will be de-identified and be publicly available only as an aggregate meta-data summary in accessible journals, with lay summaries available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16485Ethical approval  [email protected]



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.