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Trial registered on ANZCTR


Registration number
ACTRN12619001747112
Ethics application status
Approved
Date submitted
26/11/2019
Date registered
10/12/2019
Date last updated
21/06/2021
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising optometric practice provided to people with age-related macular degeneration (AMD)
Scientific title
Assessing improvements in Australian optometrists’ knowledge and management of Age-related macular degeneration (AMD) using in-office interventions in a randomised controlled study
Secondary ID [1] 299918 0
None.
Universal Trial Number (UTN)
U1111-1244-6025
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related macular degeneration 315347 0
Condition category
Condition code
Eye 313649 313649 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: Classification of Age-related macular degeneration and Risk Assessment Tool (CARAT) online intervention.

Description:
This arm will be assigned an online intervention (the CARAT tool) that will assist optometrists with calculating a patient’s risk of progression to late-stage AMD, based on patient risk factors and clinical signs. Participants (optometrists) will need to enter information regarding their patient’s risk factors (such as age, family history of AMD, current smoking status and presence of reticular pseudodrusen) and clinical signs (such as size of drusen, AMD pigmentary changes) which will assist in classifying the severity of AMD, calculating the risk of progression to late-stage AMD, and providing appropriate management advice to patients (including review periods). A link to a supporting document will provide participants with further information to assist with managing a patient with AMD. In-office use of the online tool should take the optometrist 2-3 minutes. It is intended to be used with the patient, towards the end of the clinical examination whilst discussing clinical management. The CARAT online tool and the supporting document were designed specifically for this project and are not generally available. Participants will not receive a summary of their input but are required to enter their management recommendations in their patient clinical records, as per standard practice.

Intervention 2: : Classification of Age-related macular degeneration and Risk Assessment Tool (CARAT) paper-based intervention.

This arm will be assigned a similar intervention to Arm 1, however it will be delivered in a paper-based format. Participants will be provided with a flowchart to use when managing a patient with AMD. The chart will begin with information regarding patient’s risk factors including age, family history of AMD, current smoking status and presence of reticular pseudodrusen. The second part of the chart provides optometrists with a flowchart to classify AMD severity based on clinical signs and leads to an appropriate management recommendation. Arm 2 will also be provided with the same supporting manual as Arm 1, but in a paper-based form. In-office use of the paper-based tool should take the optometrist about 2-3 minutes. It is intended to be used with the patient, towards the end of the clinical examination whilst discussing clinical management. The CARAT paper-based tool and the supporting documentation weres designed specifically for this project and are not generally available. Participants will not receive a summary of their input but are required to enter their management recommendations, in their patient clinical records, as per standard practice.
Intervention code [1] 316192 0
Behaviour
Comparator / control treatment
This arm will be assigned to use a custom Google form that has been created for optometrists to enter relevant clinical data relating to the patients they provide care to with AMD. Broad sub-headings such as patient demographics, clinical signs, clinical management including review period are used to prompt participants to enter relevant data. After completing submissions for approximately 5 patients, participants will be emailed a summary of their input. The patient information is recommended to be entered independent to the patient, in the optometrist’s own time, and should not take more than 5 minutes per patient entry.
Control group
Placebo

Outcomes
Primary outcome [1] 322084 0
Change, from baseline, in the proportion of clinical records documenting an accurate classification of AMD severity, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [1] 322084 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [1] 377276 0
Change, from baseline, in the proportion of clinical records documenting current smoking status, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [1] 377276 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [2] 377277 0
Change, from baseline, in the proportion of clinical records documenting, the presence/absence of a family history of AMD, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [2] 377277 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [3] 377293 0
Change, from baseline, in the proportion of clinical records documenting the presence or absence of reticular pseudodrusen, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [3] 377293 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [4] 377294 0
Change, from baseline, in the proportion of clinical records documenting patient management advice, where indicated based on the clinical signs of the worst eye, for dietary behaviours, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [4] 377294 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [5] 377295 0
Change, from baseline, in the proportion of clinical records documenting patient management advice, where indicated based on the clinical signs of the worst eye, for nutritional supplementation information, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [5] 377295 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [6] 377296 0
Change, from baseline, in the proportion of clinical records documenting provision of an Amsler grid (as appropriate, based upon severity staging), for patient home monitoring, based on manual self-audit of AMD patient records using the MaD-CCAT.
Timepoint [6] 377296 0
After completion of 10 patients using the tool (approximately 3 months)
Secondary outcome [7] 377297 0
Change, from baseline, in knowledge about AMD, as determined by the score obtained from multiple choice questions from a series of theoretical case studies. The multiple-choice questions for the theoretical case studies were designed specifically for this study.
Timepoint [7] 377297 0
After completion of 10 patients using the tool (approximately 3 months) and the clinical audit.

Eligibility
Key inclusion criteria
- AHPRA registered optometrists
- Currently practicing optometry in Australia
- Currently providing clinical care to patients with AMD
- Have access to their own clinical records
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Currently practicing optometry overseas

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)
Sealed opaque envelopes will be used to conceal the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created using a computer-generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 45 optometrists practicing in Australia will be recruited, resulting in 15 optometrists per study arm. Given the exploratory nature of the study, this sample size is a convenience sample, based upon the interest and completion of the Macular Degeneration Clinical Care Audit Tool (MaD-CCAT) study conducted by the same research group.

Repeated measures analyses of variance (RM-ANOVA) will be performed to assess for intervention effects over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2019
Actual
10/12/2019
Date of last participant enrolment
Anticipated
1/03/2020
Actual
17/07/2020
Date of last data collection
Anticipated
31/05/2020
Actual
14/12/2020
Sample size
Target
45
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304381 0
Charities/Societies/Foundations
Name [1] 304381 0
Macular Disease Foundation of Australia
Country [1] 304381 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Victoria 3010
Australia
Country
Australia
Secondary sponsor category [1] 304640 0
None
Name [1] 304640 0
Address [1] 304640 0
Country [1] 304640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304818 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 304818 0
University of Melbourne Human Research Ethics Committee
The University of Melbourne
Parkville, Victoria 3010
Ethics committee country [1] 304818 0
Australia
Date submitted for ethics approval [1] 304818 0
Approval date [1] 304818 0
26/06/2019
Ethics approval number [1] 304818 0
1851607.3

Summary
Brief summary
This project focuses on investigating the implementation of a set of new clinical tools, for intended in-office use by optometrists, to support best-practice care provision to people with AMD. We are also aiming to support and engage optometrists to audit their own clinical practices, using the Macular Degeneration Clinical Care Audit Tool (MaD-CCAT), which we previously developed with funding support from the Macular Disease Foundation of Australia.

We expect these tools will result in an improvement in accurate classification of AMD severity and management advice provided to patients with AMD to ensure consistency in optometric practice, and in the longer-term may have the capacity to be disseminated both nationally and internationally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98306 0
A/Prof Laura Downie
Address 98306 0
Department of Optometry and Vision Sciences
The University of Melbourne
Parkville
Victoria 3010
Country 98306 0
Australia
Phone 98306 0
+61 3 9035 3043
Fax 98306 0
Email 98306 0
[email protected]
Contact person for public queries
Name 98307 0
Sena Gocuk
Address 98307 0
Department of Optometry and Vision Sciences
The University of Melbourne
Parkville
Victoria 3010
Country 98307 0
Australia
Phone 98307 0
+61 3 9035 3043
Fax 98307 0
Email 98307 0
[email protected]
Contact person for scientific queries
Name 98308 0
Laura Downie
Address 98308 0
Department of Optometry and Vision Sciences
The University of Melbourne
Parkville
Victoria 3010
Country 98308 0
Australia
Phone 98308 0
+61 3 9035 3043
Fax 98308 0
Email 98308 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
Data collected will be confidential patient record data. Results of the audit will provide sufficient data as required.


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.