Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000844842p
Ethics application status
Submitted, not yet approved
Date submitted
27/05/2021
Date registered
1/07/2021
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Fundus EDucation: Analysing the utility of an online education tool in improving the diagnostic accuracy of fundus image interpretation amongst Emergency Doctors and Medical Students
Scientific title
Fundus EDucation: Analysing the utility of an online education tool in improving the diagnostic accuracy of non-mydriatic fundus photography image interpretation amongst Emergency Doctors and Medical Students
Secondary ID [1] 304221 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Headache 322034 0
Visual Disturbance 322035 0
Neurological Disturbance 322036 0
Severe Hypertension 322069 0
Fundus Abnormalities 322488 0
Condition category
Condition code
Eye 319766 319766 0 0
Diseases / disorders of the eye
Emergency medicine 319767 319767 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of Intervention: Fundus interpretation e-learning tool
- Participants will receive a 30-minute lecture on fundus image interpretation by an ophthalmologist
- The group will be randomised immediately following the lecture with half given access to an online e-learning tool created using ophthalmologist reviewed cases of fundus images common in an Emergency Department setting. The learning tool will include a variety of activities including informative slides and interactive activities. This has been created by a medical student with the help of a steering committee comprised of Emergency physicians, nurses and ophthalmologists
- Website analytics will inform us of participant completion of the activity.
- The e-learning tool takes approximately 30 mins to complete
Intervention code [1] 320644 0
Treatment: Other
Comparator / control treatment
-Participants will receive the same lecture as the control group on fundus interpretation.
They will then have access to a electronic PDF education manual (Eye Emergency Manual)

- The Eye Emergency Manual is not study-specific and is available online at https://www.aci.health.nsw.gov.au/__data/assets/pdf_file/0013/155011/eye_manual.pdf
Control group
Active

Outcomes
Primary outcome [1] 327635 0
Correct identification of normal vs abnormal fundus images in a study-specific online case series assessment using cases validated in a previous study.

Dunn, H. P. et al. Using non-mydriatic fundus photography to detect fundus pathology in Australian metropolitan emergency departments: A prospective prevalence and diagnostic accuracy study. Emerg. Med. Australas. 33, 302–309 (2021)
Timepoint [1] 327635 0
Case series assessment will be given 2 weeks post the initial lecture, with the education tool/ PDF given immediately following the lecture
Secondary outcome [1] 396010 0
Correct identification of specific fundus pathology diagnosis in a study-specific online case series assessment using cases validated in a previous study.

Dunn, H. P. et al. Using non-mydriatic fundus photography to detect fundus pathology in Australian metropolitan emergency departments: A prospective prevalence and diagnostic accuracy study. Emerg. Med. Australas. 33, 302–309 (2021)
Timepoint [1] 396010 0
Assessed separately at 2 and 6 weeks post lecture/learning tool distribution
Secondary outcome [2] 396013 0
Correct identification of appropriate management plans related to the presenting fundus pathology in a study-specific online case series assessment using cases validated in a previous study.

Dunn, H. P. et al. Using non-mydriatic fundus photography to detect fundus pathology in Australian metropolitan emergency departments: A prospective prevalence and diagnostic accuracy study. Emerg. Med. Australas. 33, 302–309 (2021)
Timepoint [2] 396013 0
Assessed separately at 2 and 6 weeks post lecture/learning tool distribution
Secondary outcome [3] 396074 0
Correct identification of normal vs abnormal image in a study-specific online case series assessment using cases validated in a previous study.

Dunn, H. P. et al. Using non-mydriatic fundus photography to detect fundus pathology in Australian metropolitan emergency departments: A prospective prevalence and diagnostic accuracy study. Emerg. Med. Australas. 33, 302–309 (2021)
Timepoint [3] 396074 0
Assessed 6 weeks post lecture/ learning tool distribution

Eligibility
Key inclusion criteria
- Aged 18 or older
-Doctors working in the Emergency Department at any level of training
- Medical Students years 4-6
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

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)
Centralised computerised allocation concealment. Randomisation will only be performed once the participant is enrolled and has completed their baseline data acquisition to avoid recruitment bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
statistical analysis will be performed using R and Continuous data will be reported as medians and interquartile ranges and statistical significance will be set at 0.05%. Proportions will be reported as point-estimates with 95% confidence intervals (95%CI), calculated using the binomial distribution where applicable. Logistic regression will be performed to determine the association between diagnostic accuracy and level of medical experience (post graduate years). Diagnostic accuracy for the presence or absence of any acute pathology will be assessed with sensitivity and specificity and false positive and false negative rates calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/07/2021
Actual
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
17/09/2021
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19536 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 19537 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 19547 0
Westmead Hospital - Westmead
Recruitment hospital [4] 19548 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 34145 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 34146 0
2170 - Liverpool
Recruitment postcode(s) [3] 34156 0
2145 - Westmead
Recruitment postcode(s) [4] 34157 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 308601 0
Other Collaborative groups
Name [1] 308601 0
Port Macquarie Eye Centre
Country [1] 308601 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 309461 0
None
Name [1] 309461 0
Address [1] 309461 0
Country [1] 309461 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308532 0
Human Research Ethics Committee UNSW
Ethics committee address [1] 308532 0
Ethics committee country [1] 308532 0
Australia
Date submitted for ethics approval [1] 308532 0
18/05/2021
Approval date [1] 308532 0
Ethics approval number [1] 308532 0
HC210345

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

Contacts
Principal investigator
Name 111038 0
Dr Hamish Dunn
Address 111038 0
Port Macquarie Eye Centre, 35 Ackroyd Street, Port Macquarie, NSW, 2444
Country 111038 0
Australia
Phone 111038 0
+61 2 65845554
Fax 111038 0
Email 111038 0
[email protected]
Contact person for public queries
Name 111039 0
Emma O'Donoghue
Address 111039 0
UNSW Rural Clinical School, 26 Highfields Cct, Port Macquarie, NSW, 2444
Country 111039 0
Australia
Phone 111039 0
+61 456646584
Fax 111039 0
Email 111039 0
[email protected]
Contact person for scientific queries
Name 111040 0
Hamish Dunn
Address 111040 0
Port Macquarie Eye Centre, 35 Ackroyd Street, Port Macquarie, NSW, 2444
Country 111040 0
Australia
Phone 111040 0
+61 2 65845554
Fax 111040 0
Email 111040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual, de-identified data underlying published results.
When will data be available (start and end dates)?
Beginning 6 months after and ending 3 years after publication of main results.
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Meta-analyses or to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11781Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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