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Trial registered on ANZCTR


Registration number
ACTRN12616001194459
Ethics application status
Approved
Date submitted
26/08/2016
Date registered
30/08/2016
Date last updated
30/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing management practices and residents' eye health in residential aged care facilities to develop a new model of eye care.
Scientific title
Assessing management practices and residents' eye health in residential aged care facilities to develop a new model of eye care.
Secondary ID [1] 290027 0
4-Z2BG1B (Australian Commonwealth Dept of Health Grant number)
Universal Trial Number (UTN)
U1111-1186-9219
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular degeneration 300054 0
Diabetic retinopathy 300055 0
Cataracts 300056 0
Glaucoma 300057 0
Eye disease 300058 0
Condition category
Condition code
Eye 299944 299944 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Approximately 200 consenting residents from residential aged care facilities will have their overall eye health determined by an eye exam within the aged care facility. All tests are non-invasive and will be performed at a single testing session for each participant. They include:
i) visual acuity (near and distance)
ii) contrast sensitivity
iii) simple refraction (using autorefraction)
iv) check of existing glasses using vertometer
v) slit lamp examination
vi) non-mydriatic fundus (retinal) photography
vii) optical coherence tomography (OCT)
viii) intra-ocular pressure test ("puff" test)
ix) confrontational visual field test
No dye injections will be given, and mydriatic eye drops (to enlarge the pupil) will not be used.
Tests and scans will be reviewed by a qualified orthoptist and checked by an ophthalmologist with a subspecialty in retinal conditions. Any resident with an undiagnosed eye condition will be encouraged to seek further review and possible treatment, however this will fall outside the scope of this trial.
The policies and procedures within each aged care facility in relation to their management of eye health will then be reviewed. Issues such as recording of eye diseases, ongoing eye testing, procedures (including the training of staff) regarding the management of people with low vision, transportation to eye care appointments and ongoing follow-up will be recorded.
Optometrists who provide in-house testing of residents will also be interviewed to clarify their procedures, referral patterns, recording methods and tests used.
Data generated by the eye testing and the surveys will be used to develop an eye health model of care for people in residential aged care facilities. This will include the development of training material for facility staff and the families of residents.
The draft model of care and other resources will be developed in collaboration with an expert panel and the facilities,
Following pilot testing of the draft model of care and resources, the final model and modified resources will be published and promulgated nationally.
Intervention code [1] 295743 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299434 0
Percentage of residents with undiagnosed or unreported eye disease which could impact vision and/or require ongoing monitoring, treatment or special management.
All resident eye tests and scans will be assessed by the research orthoptist and reviewed by an ophthalmologist to determine the presence of any significant eye disease. These results will be compared to each resident's health record within each facility
Timepoint [1] 299434 0
One-off test
Secondary outcome [1] 327135 0
Comprehensive recording of facility polices and procedures regarding the recording, monitoring and management of residents' eye health. This will be achieved with a staff interview and checking of any patient documentation (paper and/or electronic).
Items to be recorded include, but are not limited to:
a) how the facility manages the health records of residents (eg electronically, hard copies) and when this is done
b) Whether the facility records the resident's GP, optometrist, specialist consultations and results
c) Who manages the resident's external medical appointments (booking, transportation etc)?
d) Whether the facility arranges regular in-facility optometry checks
e) Whether the facility has a systematic mechanism to ensure all residents are checked on a regular basis and keep any follow-up consultations
f) whether the facility provides regular training to staff to enable better care of people with reduced vision
g) Whether the facility provides any low vision aids such as desktop magnifiers for use by residents with low vision
Timepoint [1] 327135 0
One-off recording
Secondary outcome [2] 327232 0
Assessment of optometrist practices for in-facility testing
Timepoint [2] 327232 0
Interviews will be held with optometrists who provide in-facility testing of residents to clarify or confirm:
a) what tests they provide
b) triggers for referral and their referral patterns
c) the documentation they provide, and to whom
d) follow-up to ensure regular testing of residents
e) how (and whether) they manage more difficult residents (eg those with severe dementia, mobility issues)

Eligibility
Key inclusion criteria
Consenting residents of 8 aged care facilities.
Estia Health Mona Vale - 50 Golf Ave, Mona Vale 2103
Estia Health Epping - 64 Norfolk Rd, Epping 2121
Presbyterian Aged Care Drummoyne (Minnamurra) - 14 Clements St, Drummoyne 2047
Presbyterian Aged Care Ashfield - 40 Charlotte St, Ashfield 2131
Baptist Care Cooinda Court - 159 Balaclava Rd, Macquarie Park 2113
Baptist Care Dorothy Henderson Lodge - 157 Balaclava Rd, Macquarie Park 2113
Baptist Care Yallambi Centre - 268 Pennant Hills Rd, Carlingford 2118
Allambie Heights Village, 3 Martin Luther Cl, Allambie Heights 2100
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking resident with no interpreter services readily available.
Residents (or their guardian) who are unwilling to sign an informed consent form.
Severe dementia, extreme frailty, or other condition making testing impractical or impossible.
Terminally ill residents in whom there will be no likely benefit of testing.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The planned number of 200 residents is based on a recommendation by Prof Paul Mitchell, the Chief Investigator of the Blue Mountains Eye Study, which also included testing of RACFs in the late 1990s. Prof Mitchell stated that testing of 200 residents should reveal at least 5 to 10 cases of late stage macular degeneration which would enable a clear indication of the extent of undetected or undocumented eye disease in this population.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/04/2016
Date of last participant enrolment
Anticipated
Actual
8/08/2016
Date of last data collection
Anticipated
12/08/2016
Actual
11/08/2016
Sample size
Target
200
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14139 0
2103 - Mona Vale
Recruitment postcode(s) [2] 14140 0
2121 - Epping
Recruitment postcode(s) [3] 14141 0
2047 - Drummoyne
Recruitment postcode(s) [4] 14142 0
2131 - Ashfield
Recruitment postcode(s) [5] 14143 0
2113 - Macquarie Park
Recruitment postcode(s) [6] 14144 0
2100 - Allambie Heights
Recruitment postcode(s) [7] 14145 0
2118 - Carlingford

Funding & Sponsors
Funding source category [1] 294394 0
Government body
Name [1] 294394 0
Commonwealth Dept of Health
Country [1] 294394 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Macular Disease Foundation Australia
Address
Suite 902
447 Kent St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 293242 0
None
Name [1] 293242 0
Address [1] 293242 0
Country [1] 293242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295816 0
Bellberry Limited
Ethics committee address [1] 295816 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 295816 0
Australia
Date submitted for ethics approval [1] 295816 0
15/12/2015
Approval date [1] 295816 0
16/03/2016
Ethics approval number [1] 295816 0
2015.06.393.A1

Summary
Brief summary
The overall aim of this project is to improve and preserve optimal visual function of residents in Australian residential aged care facilities (RACFs), in order to improve or optimise this critical sensory input in their already restricted environment.
There is clear evidence that people living in RACFs have more vision issues which are not adequately managed, when compared to similarly aged people living in their own home. Vision issues include macular degeneration (the main cause of blindness and major vision loss in people over 50), glaucoma, diabetic retinopathy, untreated cataract, uncorrected refractive error and many other conditions.
Eye testing of residents will be conducted to quantify the extent of vision issues in these facilities, and to test the practicality of onsite testing, or alternate means when necessary.
After gaining a detailed knowledge base of the current landscape, legislative requirements and issues through consultation with an expert reference group, the project will identify the existing eye health practices in eight different RACFs from four different providers (Estia Health, Presbyterian Aged Care, BaptistCare, Allambie Heights Village) using a detailed audit. The facilities to be audited will have varying levels of additional services provided. The audit will focus on existing policies and procedures to determine: a) whether appropriate baseline records of a resident's vision are obtained; b) whether residents obtain regular ongoing eye tests, and if so, how; c) whether resident care (including treatment and rehabilitation) is modified as a result of vision issues; d) the extent of communication regarding eye health with the residents' healthcare providers (eg GP and relevant specialists) and family. Using input from the expert reference group, a draft 'minimum standard of care' model will be developed. A manual will then be produced to provide a practical/workable guide for use in RACFs. In addition, an audio-visual education tool will be developed for use by RACF management and staff, as well as an educational publication for families. The manual and video will then be tested within the RACFs prior to final production and distribution to all RACFs across Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68582 0
Ms Julie Heraghty
Address 68582 0
Macular Disease Foundation Australia
Suite 902
447 Kent St
Sydney NSW 2000
Country 68582 0
Australia
Phone 68582 0
+61 2 92618900
Fax 68582 0
+61 2 92618912
Email 68582 0
[email protected]
Contact person for public queries
Name 68583 0
Rob Cummins
Address 68583 0
Macular Disease Foundation Australia
Suite 902
447 Kent St
Sydney NSW 2000
Country 68583 0
Australia
Phone 68583 0
+61 2 92618900
Fax 68583 0
+61 2 92618912
Email 68583 0
[email protected]
Contact person for scientific queries
Name 68584 0
Rob Cummins
Address 68584 0
Macular Disease Foundation Australia
Suite 902
447 Kent St
Sydney NSW 2000
Country 68584 0
Australia
Phone 68584 0
+61 2 92618900
Fax 68584 0
+61 2 92618912
Email 68584 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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