Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000603910p
Ethics application status
Not yet submitted
Date submitted
11/02/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of customised distraction techniques for managing acute behavioural disturbance in patients aged 65 years or older in the emergency department
Scientific title
development of customised distraction techniques for managing acute behavioural disturbance in patients aged 65 years or older in the emergency department
Secondary ID [1] 300518 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 316212 0
delirium 316213 0
Condition category
Condition code
Neurological 314503 314503 0 0
Dementias
Neurological 314646 314646 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will test various technologies to provide multimedia distraction, including immersive Virtual Reality (VR) headsets with and without audio; close-proximity screens, with and without audio, and other relevant devices such as audio devices alone. Devices included will be a VR headset: Oculus Quest 64GB, and an immersive multimedia screen to fill patients field of view without the need for a headset. This consists of a curved monitor display (such as LG 38WK95C-W) mounted to a cart with an articulating arm (enabling it to be positioned directly in front of the patient) such as the PDI MedTV Cart. Therefore there are two devices being used, however these may be modified in an iterative fashion as the project progresses.
The actual imagery we will test may include, but is not limited to, nature scenes (eg walking in a forest), underwater scenery, geometric patterns, imagery of different world cities etc.
The intervention will be delivered by a research assistant, who will guide the user through and collect data.
Each participant will use more than one device, with a maximum of three devices, but will only be allocated to a single sitting. Total participation time will be limited to 1 hour. The location will be either in a residential aged care facility, or in the emergency department of Cabrini Hospital. The number of devices used will be determined by the maximum time frame of 1 hour as well as patient discretion.
The three (stepwise) stages are:

1. Healthy volunteers
2. Residents with known cognitive impairment
3. ED patients with acute behavioural disturbance
Intervention code [1] 316825 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322830 0
This is primarily an early-phase feasibility study of a novel intervention.
The primary outcome is acceptability of the intervention to the patient and caregivers as determined by a study-specific questionnaire.
Timepoint [1] 322830 0
At the completion of the session.
Secondary outcome [1] 380843 0
Frequency and dose of medications used to control acute behavioural disturbance
This will be assessed by querying the electronic medication record of hospital patients
Timepoint [1] 380843 0
At completion of ED visit

Eligibility
Key inclusion criteria
Stage 1 Healthy volunteers
Stage 2 Residents with known cognitive impairment
Stage 3 ED patients with Acute Behavioural Disturbance (ABD)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stage 1
Cognitive impairment
Hearing or sight impaired
Significant limitations in manual dexterity, e.g. inability to operate simple controls
Insufficient English to understand an explanation of the study and provide consent

Stage 2
? Hearing or sight impaired
? Acutely behaviourally disturbed

Stage 3
? Patients meeting “Code Grey” criteria i.e. violence or severe agitation
? Patients previously enrolled in the ED setting

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15866 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 29315 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 304931 0
Hospital
Name [1] 304931 0
Cabrini Health
Country [1] 304931 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Health
Address
183 Wattletree Road
Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 305284 0
None
Name [1] 305284 0
Address [1] 305284 0
Country [1] 305284 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305340 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305340 0
Locked Bag 29
Clayton VIC 3168
Ethics committee country [1] 305340 0
Australia
Date submitted for ethics approval [1] 305340 0
30/06/2020
Approval date [1] 305340 0
Ethics approval number [1] 305340 0

Summary
Brief summary
This is a pilot study using technologically advanced customised distraction techniques to prevent and manage acute behavioural disturbance (ABD) in elderly patients in the emergency department (ED).
Acute behavioural disturbance is a common problem in EDs, particularly in elderly patients and even more so in those with cognitive impairment, for example people with delirium or dementia. This behaviour endangers the patients themselves, their companions, other patients and ED staff, and hampers timely delivery of their care. Current treatment options, including psychotropic medication and mechanical restraint remain of limited benefit, confer risk and are of limited efficacy.
Despite recognition that they are preferred practice, distraction techniques are rarely used in the management of patients with ABD in the ED setting; with the vast majority of cases managed using psychotropic medications, often administered parenterally, and often without patient consent under the Principle of Necessity. These medications have significant adverse effect profiles; complications can include over-sedation with hypoxia or hypotension, falls and subsequent injuries as well as prolonged lengths of stay and increased mortality. In the ED, available non-pharmacological options are limited, rendering the investigation of distraction techniques such as the use of virtual reality (VR) and other multimedia approaches in this setting an important initiative.
We aim to perform an iterative process of testing, adaptation and refinement of devices and media to develop customised distraction techniques for elderly patients who exhibit ABD in Cabrini ED.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100054 0
Dr Gabriel Blecher
Address 100054 0
Cabrini Health
Emergency Department
183 Wattletree Road
Malvern VIC 3144
Country 100054 0
Australia
Phone 100054 0
+61395081550
Fax 100054 0
Email 100054 0
[email protected]
Contact person for public queries
Name 100055 0
Dr Gabriel Blecher
Address 100055 0
Cabrini Health
Emergency Department
183 Wattletree Road
Malvern VIC 3144
Country 100055 0
Australia
Phone 100055 0
+61395081550
Fax 100055 0
Email 100055 0
[email protected]
Contact person for scientific queries
Name 100056 0
Dr Gabriel Blecher
Address 100056 0
Cabrini Health
Emergency Department
183 Wattletree Road
Malvern VIC 3144
Country 100056 0
Australia
Phone 100056 0
+61395081550
Fax 100056 0
Email 100056 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
Privacy, ethics


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.