Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000217808
Ethics application status
Approved
Date submitted
19/01/2021
Date registered
3/03/2021
Date last updated
3/03/2021
Date data sharing statement initially provided
3/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Patients' Attitudes Towards The Use Of Artificial Intelligence In Their Emergency Care
Scientific title
Patients' Attitudes Towards The Use Of Artificial Intelligence In Their Emergency Care
Secondary ID [1] 303215 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency Care 320363 0
Condition category
Condition code
Emergency medicine 318268 318268 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The survey has been designed specifically for this study. Survey questions have been developed with input from specialists in emergency medicine, computer science and artificial intelligence, and consumers to ensure face validity. The survey to be used will be piloted in a small representative sample of around 50 patients. If required survey questions will be iteratively updated. Surveys will be conducted by researchers blinded to study hypothesis. Following informed consent, patients in the emergency department will complete a paper-based survey. The anticipated duration of this survey is approximately 5 minutes. If patients cannot read English the survey will be conducted through a standardised and structured interview (~5 minutes duration).
Intervention code [1] 319529 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326253 0
Emergency department patients' attitudes towards the use of artificial intelligence in their emergency care assessed by study-specific survey
Timepoint [1] 326253 0
Assessed at a once-off participant survey
Secondary outcome [1] 390754 0
Emergency department patients' concerns towards the use of artificial intelligence in their emergency care assessed by study-specific survey
Timepoint [1] 390754 0
Assessed at a once-off participant survey

Eligibility
Key inclusion criteria
Patients presenting to Hospital Emergency Departments with an Australasian Triage Score category of 2, 3, 4, or 5. Patients will be considered eligible if they are over 18 and able to give informed consent to participate in the survey.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if they are aged under 18, if they are acutely psychotic, if they are intoxicated, if they are cognitively impaired, if they do not speak English, or if the urgency of their clinical care precludes them from participating in a survey.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
In order to validate our survey we will conduct an initial pilot survey (50-100 patients) on our intended population, then analysis this through principal component analysis to identify underlying factors, and Cronbach's alpha to test internal consistency. Following the results of this pilot we will re-evaluate our survey questions and if necessary update them and repeat this process.

We will again assess our data through principal component analysis and Chronbach's alpha following completion of the formal data collection. We will provide simple descriptive statistics of survey results, including subgroup analysis by age, sex, and hospital. We will also assess for correlation between questions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2021
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
385
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18466 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 18467 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 18468 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 32576 0
6150 - Murdoch
Recruitment postcode(s) [2] 32577 0
6009 - Nedlands
Recruitment postcode(s) [3] 32578 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 307623 0
Other Collaborative groups
Name [1] 307623 0
Western Australian Health Translation Network
Country [1] 307623 0
Australia
Primary sponsor type
Individual
Name
Dr Jonathon Stewart
Address
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 308311 0
Individual
Name [1] 308311 0
Prof Girish Dwivedi
Address [1] 308311 0
Harry Perkins Institute of Medical Research
5 Robin Warren Dr, Murdoch WA 6150
Country [1] 308311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307669 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 307669 0
Ethics committee country [1] 307669 0
Australia
Date submitted for ethics approval [1] 307669 0
11/08/2020
Approval date [1] 307669 0
02/10/2020
Ethics approval number [1] 307669 0

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

Contacts
Principal investigator
Name 108074 0
Dr Jonathon Stewart
Address 108074 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country 108074 0
Australia
Phone 108074 0
+61 435211352
Fax 108074 0
Email 108074 0
jonathon.stewart@health.wa.gov.au
Contact person for public queries
Name 108075 0
Jonathon Stewart
Address 108075 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country 108075 0
Australia
Phone 108075 0
+61 435211352
Fax 108075 0
Email 108075 0
jonathon.stewart@health.wa.gov.au
Contact person for scientific queries
Name 108076 0
Jonathon Stewart
Address 108076 0
The University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Country 108076 0
Australia
Phone 108076 0
+61 435211352
Fax 108076 0
Email 108076 0
jonathon.stewart@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.