Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000582853
Ethics application status
Approved
Date submitted
1/11/2020
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Date results provided
17/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and efficacy of video-based falls prevention education for cognitively impaired hospital inpatients – a pilot study
Scientific title
Feasibility and efficacy of video-based falls prevention education for cognitively impaired hospital inpatients – a pilot study
Secondary ID [1] 302604 0
Nil known
Universal Trial Number (UTN)
U1111-1260-0124
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 319492 0
cognitive impairment 319493 0
dementia 321132 0
Condition category
Condition code
Injuries and Accidents 317457 317457 0 0
Other injuries and accidents
Neurological 318933 318933 0 0
Dementias
Neurological 318937 318937 0 0
Other neurological disorders
Neurological 318938 318938 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Educational falls prevention video

Why: It was a silent video that communicated primarily with universal body language and symbols (ticks and crosses) with the aim of overcoming language barriers that were common to the culturally and linguistically diverse local geriatric population. The main message of the video is to instruct patients to ask for help if they want to get out of bed and ambulate to the toilet. Most inpatient falls in older adults occur around the bed area and in the toilet, when patients attempt to transfer and ambulate without asking for nursing assistance. The visual instruction was strengthened by the scenes of broken bones to arouse emotional memory (emotional scenes are better remembered than ordinary ones).

What: Materials: 1. education video as described above 2. Computers on wheels
Procedures: Investigators used computers on wheels to play the educational video to patients randomized to the intervention arm. After the video finishes playing, the investigators asked the patient what the video was about and explained the video if they didn't get the message. They asked patients to remember the video's message for the following day.

Who provided: Doctors and nurses, both junior and senior, who had been briefed about this project, showed the video to patients.

How: face to face education provided to individual patients

Where: Bankstown-Lidcombe hospital, Sydney, NSW, Australia. Tertiary teaching hospital ~454 beds. Inpatient setting, on various wards (general medical, surgical, stroke, cardiology, acute geriatric, rehabilitation, psychogeriatric, medical assessment unit). We didn't include mental health, dialysis unit or emergency department.

When and How much: The video was played once to each patient in the intervention arm. The intervention could take place any time of day between 9am to 8pm. The video was 40 seconds long, but the face to face sessions to deliver and discuss the video would take around 3 minutes.

Tailoring: The procedure of showing this educational video and discussing it with patients was standardized. Patients who were unable to watch the video (e.g. blind, drowsy) were excluded from randomization. Patients who were unable to discuss the contents of the video (e.g. aphasic) were also excluded from randomisation. Non english speaking patients were included if someone was available to interpret for them (e.g. carer, professional interpreter, health care worker who speaks the same language).

Modifications: Initally there was a scene in the video where the bedrail was up. Over the years, our hospital's policy changed regarding bed-rail use. This scene was subsequently changed to one with the bedrails down. This modification occurred midway through the study, after ~20 participants were enrolled

How well: Intervention fidelity was not assessed. After briefing the 4 investigators about the project, they were trusted to deliver the intervention faithfully.
Intervention code [1] 318890 0
Behaviour
Intervention code [2] 318954 0
Prevention
Comparator / control treatment
Active control: falls prevention education provided verbally

Why: The verbal falls prevention education consists of instructing the patients to call for assistance when they need to get up to go somewhere. Often patients get up on their own and mobilise without assistance to the bathroom, which may result in a fall. By indicating to nursing staff that they would like to go somewhere, the nurses will help the patient mobilise and reduce risk of falling.

What: Verbal instruction only, no physical materials.
Procedures: Investigators provide verbal falls prevention education to patients in the control arm, and ask them to remember it for the following day.
Who provided: Doctors and nurses, both junior and senior, who had been briefed about this project, provided verbal instruction to patients.

How: face to face education provided to individual patients
Where: Bankstown-Lidcombe hospital, Sydney, NSW, Australia. Tertiary teaching hospital ~454 beds. Inpatient setting, on various wards (general medical, surgical, stroke, cardiology, acute geriatric, rehabilitation, psychogeriatric, medical assessment unit). We didn't include mental health, dialysis unit or emergency department.

When and How much: The verbal education session was provided once to each patient in the control arm. The verbal education session could take place any time of day between 9am to 8pm. The face to face sessions would take around 2 minutes.

Tailoring: The verbal education session was standardized. Patients who were unable to participate (e.g. drowsy) were excluded from randomization. Patients who were unable to discuss the contents of the education session (e.g. aphasic) were also excluded from randomisation. Non english speaking patients were included if someone was available to interpret for them (e.g. carer, professional interpreter, health care worker who speaks the same language).

Modifications: none

How well: Intervention fidelity was not assessed. After briefing the 4 investigators about the project, they were trusted to deliver the intervention faithfully.
Control group
Active

Outcomes
Primary outcome [1] 325565 0
Primary Outcome: Whether the patient remembered the content of the falls prevention education provided, when asked about it the following day. Investigators would follow patients up the next day to ask "I gave you an instruction to remember yesterday, what was it?" or "I showed you a video yesterday, what was it about?" Remembrance is defined as the patient responding "if I need to go somewhere, I will ask for help" or conveying this idea with other wording. We calculate the proportion of participants that remembered this message in each group.
No instruments are used
No known adverse events related to these interventions are measured
Timepoint [1] 325565 0
Remembrance is assessed 1 day after falls education is provided
Primary outcome [2] 326863 0
Primary Outcome: Whether the patient fell during the remainder of their hospital stay. We calculate the falls rate (number of falls per occupied bed day) and falls risk (number of participants who fell) in each group after they received the falls education.
The co-primary outcome of ‘falls’ was determined by incident reports (IIMS) and corroborated with patient medical records.
No known adverse events related to these interventions are measured
Timepoint [2] 326863 0
Inpatient falls that happened after they received falls education until the participant has been discharged
Secondary outcome [1] 388399 0
nil
Timepoint [1] 388399 0
nil

Eligibility
Key inclusion criteria
Patients were included if they score below the recommended cut off on validated screening tools for cognitive impairment (MMSE <24, RUDAS <23, MOCA <26). Delirious patients are included
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they are drowsy (can’t keep eyes open to watch video) or patients who can’t express if they remember or not (aphasic/abulic). Patients are also excluded if they are very demented, and cannot follow a 3 step command. Non-english speaking patients who didn’t have anyone readily available to interpret for them were also excluded.

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)
Allocation is not concealed (non-centralised randomisation by computer/coin flip)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two randomisation methods were used, depending on the investigator's individual preference:
1. Computerised sequence generation, using https://www.randomizer.org/
2. Simple randomisation using coin-tossing for those who aren't tech-savvy
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this pilot trial, we used the 2-tailed z-test for two proportions to see if the difference in the proportion of people remembering the falls prevention message in the two groups were statistically significant. We calculated an odds ratio with 95% confidence interval to communicate the odds of one modality being better remembered than the other modality. We also calculated a risk ratio.

Based on this pilot study’s results with 50 randomized participants, we performed sample size calculations to see how many patients would be needed for a future study. A future study will need a larger sample size of 124 (62 in each group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
20/08/2020
Date of last data collection
Anticipated
Actual
20/10/2020
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17922 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 31785 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 307033 0
Hospital
Name [1] 307033 0
Bankstown-Lidcombe Hospital
Country [1] 307033 0
Australia
Primary sponsor type
Individual
Name
Daniel KY Chan
Address
Name of primary sponsor's work organisation: Bankstown-Lidcombe Hospital
Eldridge Road, Bankstown, NSW, 2200
Country
Australia
Secondary sponsor category [1] 307603 0
None
Name [1] 307603 0
Address [1] 307603 0
Country [1] 307603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307163 0
SWSLHD Human Research ethics committee
Ethics committee address [1] 307163 0
Ethics committee country [1] 307163 0
Australia
Date submitted for ethics approval [1] 307163 0
20/11/2014
Approval date [1] 307163 0
16/03/2015
Ethics approval number [1] 307163 0
HREC/14/LPOOL/530

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

Contacts
Principal investigator
Name 106250 0
Dr Daniel KY Chan
Address 106250 0
Principal Investigator's work organisation: Bankstown-Lidcombe Hospital

Eldridge Road, Bankstown, NSW, 2200
Country 106250 0
Australia
Phone 106250 0
+61 2 9722 8000
Fax 106250 0
+61 2 9722 8332
Email 106250 0
[email protected]
Contact person for public queries
Name 106251 0
Jun Dai
Address 106251 0
Name of contact person's work organisation: Bankstown-Lidcombe Hospital

Eldridge Road, Bankstown, NSW, 2200
Country 106251 0
Australia
Phone 106251 0
+61 449715850
Fax 106251 0
+61 2 9722 8332
Email 106251 0
[email protected]
Contact person for scientific queries
Name 106252 0
Jun Dai
Address 106252 0
Contact Person's work Organisation: Bankstown-Lidcombe Hospital

Eldridge Road, Bankstown, NSW, 2200
Country 106252 0
Australia
Phone 106252 0
+61 449715850
Fax 106252 0
+61 2 9722 8332
Email 106252 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
We haven't included sharing IPD in our ethics submission so we probably can't share this data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9584Ethical approval    380798-(Uploaded-01-11-2020-22-40-19)-Study-related document.pdf



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.