Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000893101
Ethics application status
Approved
Date submitted
13/06/2019
Date registered
26/06/2019
Date last updated
17/09/2021
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Implementation of a Delirium Education Intervention using Clinical Simulation in a Private Healthcare Setting
Scientific title
Evaluation of the Implementation of a Delirium Education Intervention using Clinical Simulation of Registered Healthcare Staff in a Private Healthcare Setting
Secondary ID [1] 297823 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 312189 0
Condition category
Condition code
Public Health 310738 310738 0 0
Health service research
Neurological 311705 311705 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a four part mutli-modal delirium care education program (total of 2 hours):
(i) Didactic group face to face education session delivered by a Nurse Practitioner or Clinical Nurse Consultant, including a 'take away' Delirium Care Booklet entitled 'Delirium Care-what you need to know' (60 mins).
The 'Delirium Care-what you need to know' booklet was first developed by delirium clinical experts in 2014 and is available online at http://adhere.org.au/deliriumcare.html
(ii) Online learning activity involving watching filmed delirium care vignettes (15 mins). Available online at http://adhere.org.au/deliriumcare-videos.html
(iii) Paper-based Individual Self-reflection exercise (15 mins) consisting of 4 questions to prompt participants to reflect on their experience with a patient who experienced delirium.
(iv) One-on-one objective structured clinical examination (OSCE) conducted by a Nurse Practitioner, Clinical Nurse Specialist or Clinical Nurse Educator using a simulated patient scenario role played by an 'actor' (30 minutes).
The multi-modal program will be delivered over a two month period, with participants undertaking each activity once. Participants will approximately undertake one activity every 2 weeks during a 2 month period.
Intervention code [1] 314552 0
Other interventions
Comparator / control treatment
The control group will receive a one part delirium care education session (60 mins):
(i) Didactic group face to face education session delivered by a Nurse Practitioner or Clinical Nurse Consultant, including a 'take away' Delirium Care Booklet entitled 'Delirium Care-what you need to know' (60 mins).
The 'Delirium Care-what you need to know' booklet was first developed by delirium clinical experts in 2014 and is available online at http://adhere.org.au/deliriumcare.html
Control group
Active

Outcomes
Primary outcome [1] 319587 0
Delirium care clinical practice: - Measured using a 15-point structured observation tool validated by the research team (validation of the tool is yet to be published- will update details once validation study published) - Observations of practice will be completed by a blinded researcher - Higher scores indicate a greater adherence to the application of delirium care practice learnt following education
Timepoint [1] 319587 0
T1: 6 weeks post intervention
Secondary outcome [1] 368803 0
Delirium knowledge: - Measured using a 20-item 'quiz' developed by the research team (completed as part of one survey used to generate findings about the four secondary outcomes) - Participants answer multiple choice questions - Higher scores indicate a greater knowledge of delirium care learnt following education
Timepoint [1] 368803 0
T0: Immediately before the intervention T1: 6 weeks post intervention
Secondary outcome [2] 370752 0
Self-perception about sense of confidence in delivering delirium care: - Measured using a 3 questions developed by this research team (completed as part of one survey used to generate findings about the four secondary outcomes) - Participants select their responses from 5-point Likert scale items - Higher scores indicate a greater sense of self-perception about confidence in delivering of delirium care following education
Timepoint [2] 370752 0
T0: Immediately pre-intervention T1: 6 weeks post intervention
Secondary outcome [3] 371437 0
Self-perception about sense of competence in delivering delirium care: - Measured using a 3 questions developed by this research team (completed as part of one survey used to generate findings about the four secondary outcomes) - Participants select their responses from 5-point Likert scale items - Higher scores indicate a greater sense of self-perception about confidence in delivering of delirium care following education
Timepoint [3] 371437 0
T0: Immediately pre-intervention T1: 6 weeks post intervention
Secondary outcome [4] 371452 0
Overall view about the impact of the education - Measured using 4 open ended questions developed by this research team (completed as part of one survey used to generate findings about the four secondary outcomes) - Participants provide free-text responses -Content analysis will be used to explain the value of the education on clinical practice
Timepoint [4] 371452 0
T0: Immediately pre-intervention T1: 6-weeks post-intervention

Eligibility
Key inclusion criteria
1. Registered healthcare staff: medical doctor, enrolled nurse, registered nurse or allied healthcare practitioner (physiotherpist or occupational therapist)
2. Staff member working in: medical or surgical units at one of the three participating hospitals
3. Permanent and casual staff are eligible
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unregistered staff: assistants in nursing, allied healthcare aids, hotel services and
2. Staff members working in: outpatient, maternity, paediatric, day stay, operating theatre, recovery, or critical care units

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation created by computerised random sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2019
Actual
27/06/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
1/12/2020
Date of last data collection
Anticipated
1/06/2020
Actual
12/02/2021
Sample size
Target
132
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13977 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 13978 0
Kareena Private Hospital - Caringbah
Recruitment hospital [3] 13979 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [4] 20534 0
Southern Highlands Private Hospital - Bowral
Recruitment postcode(s) [1] 26754 0
2217 - Kogarah
Recruitment postcode(s) [2] 26755 0
2229 - Caringbah
Recruitment postcode(s) [3] 26756 0
2500 - Wollongong
Recruitment postcode(s) [4] 35316 0
2576 - Bowral

Funding & Sponsors
Funding source category [1] 302347 0
Charities/Societies/Foundations
Name [1] 302347 0
Ramsay Health Reserch Foundation
Country [1] 302347 0
Australia
Primary sponsor type
Individual
Name
Professor Victoria Traynor
Address
School of Nursing
Faculty of Science, Medicine and Health
41.209 Science Buliding
Northfields Avenue
University of Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 302231 0
Individual
Name [1] 302231 0
Amy Montgomery
Address [1] 302231 0
School of Nursing Faculty of Science, Medicine and Health Science Buliding Northfields Avenue University of Wollongong NSW 2522
Country [1] 302231 0
Australia
Secondary sponsor category [2] 302962 0
Individual
Name [2] 302962 0
Professor Peter Smerdely
Address [2] 302962 0
School of Nursing Faculty of Science, Medicine and Health Science Buliding Northfields Avenue University of Wollongong NSW 2522
Country [2] 302962 0
Australia
Secondary sponsor category [3] 302963 0
Individual
Name [3] 302963 0
Dr. Rita Cheng
Address [3] 302963 0
School of Nursing Faculty of Science, Medicine and Health B41 Science Building, R 123 Northfields Avenue University of Wollongong NSW 2522
Country [3] 302963 0
Australia
Other collaborator category [1] 280748 0
University
Name [1] 280748 0
University of Wollongong
Address [1] 280748 0
Northfields Avenue University of Wollongong NSW 2522
Country [1] 280748 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303021 0
UOW & ISLHD Health and Medical Human Research Ethics Committee
Ethics committee address [1] 303021 0
Ethics committee country [1] 303021 0
Australia
Date submitted for ethics approval [1] 303021 0
04/04/2019
Approval date [1] 303021 0
01/05/2019
Ethics approval number [1] 303021 0
2019/ETH03736

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

Contacts
Principal investigator
Name 92194 0
Ms Amy Montgomery
Address 92194 0
School of Nursing Faculty of Science, Medicine and Health Science Building Northfields Avenue University of Wollongong NSW 2522
Country 92194 0
Australia
Phone 92194 0
+61 432 456 954
Fax 92194 0
Email 92194 0
[email protected]
Contact person for public queries
Name 92195 0
Amy Montgomery
Address 92195 0
School of Nursing Faculty of Science, Medicine and Health Science Buliding Northfields Avenue University of Wollongong NSW 2522
Country 92195 0
Australia
Phone 92195 0
+61 432 456 954
Fax 92195 0
Email 92195 0
[email protected]
Contact person for scientific queries
Name 92196 0
Victoria Traynor
Address 92196 0
School of Nursing Faculty of Science, Medicine and Health 41.209 Science Building Northfields Avenue University of Wollongong NSW 2522
Country 92196 0
Australia
Phone 92196 0
+61 2 4221 3471
Fax 92196 0
Email 92196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of the Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trail, after de-identification.

What types of analyses could be done with individual participant data?
• For IPD meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication; no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator.
Amy Montgomery
Email: [email protected]
School of Nursing | Science Medicine and Health
University of Wollongong NSW 2522 Australia

Are there extra considerations when requesting access to individual participant data?
No


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.