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Trial registered on ANZCTR


Registration number
ACTRN12617001420336
Ethics application status
Approved
Date submitted
29/09/2017
Date registered
9/10/2017
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of clinical assessment for diabetic retinopathy by ophthalmologists and optometrists at a hospital-based multidisciplinary clinic to prevent vision related complications in patients with diabetes
Scientific title
Evaluation of efficiency, satisfaction and costs of clinical assessment for diabetic retinopathy by ophthalmologists and optometrists at the Sutherland Hospital Eye clinic for patients with Diabetes
Secondary ID [1] 293024 0
Nil known
Universal Trial Number (UTN)
U1111-1202-9554
Trial acronym
ESHED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic retinopathy 304933 0
Condition category
Condition code
Eye 304262 304262 0 0
Diseases / disorders of the eye
Public Health 304263 304263 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is provided through a clinical assessment for diabetic retinopathy at the Sutherland Hospital ophthalmology department in the form of a face-to-face consult with an attending ophthalmologist. The assessment will consist of standard clinical care including, but not limited to, patient history, VA assessment, pupil assessment, slit lamp examination, tonometry, pupil dilation, Optomap imaging, retinal photography, or optical coherence tomography as clinically appropriate. Time of the intervention will vary, but is expected to take 1-2 hours.
Intervention code [1] 299256 0
Early detection / Screening
Comparator / control treatment
The control group is provided with a clinical assessment for diabetic retinopathy at the CFEH-Sutherland Hospital clinic in the form of a face-to-face consult with an attending optometrist. The assessment will consist of standard clinical care including, but not limited to, patient history, VA assessment, pupil assessment, slit lamp examination, tonometry, pupil dilation, Optomap imaging, retinal photography, or optical coherence tomography as clinically appropriate. Time of the intervention will vary, but is expected to take 1-2 hours.
Control group
Active

Outcomes
Primary outcome [1] 303542 0
Appointment wait time
To assess the efficiency of the TSH eye clinic, the appointment wait time, defined as difference between receipt of patient referral and eye examination appointment date, will be recorded and compared between the control and intervention cohort 6, 12 and 24 months after trial commencement. Additionally, change analysis will be performed to ascertain whether wait times have changed at either clinical site throughout the research period.
Timepoint [1] 303542 0
6 and 12 months after trial commencement and at the conclusion of the project (24 months or once target size of 200 patients is reached)
Primary outcome [2] 303543 0
Patient outcome
Clinical outcomes and recommended management decisions will be examined to identify patients whose outcomes are inconsistent with being triaged to the CFEH-TSH clinic. Proportion of patients correctly triaged will be calculated for each arm of the clinical trial and compared at the conclusion of the trial. False positive and negative rates will be calculated for patients identified in need of urgent specialist care during clinical assessment.
Timepoint [2] 303543 0
At the conclusion of the project, once target size (200 patients) is reached
Secondary outcome [1] 339270 0
Service costing
Process mapping from data collected in form B and associated service costs will be used to establish comparative costs for services offered to the intervention and control group.
Timepoint [1] 339270 0
At the conclusion of the project, once target size (200 patients) is reached
Secondary outcome [2] 339271 0
Patient satisfaction and quality of life
The results of a combined patient satisfaction and quality of life survey (modified PSQ18) will be used as quality control to inform consistency of clinical assessments throughout the project and establish patient acceptance of services
Timepoint [2] 339271 0
At the conclusion of the optometrist/ophthalmologist consultation

Eligibility
Key inclusion criteria
18 years of age of above
Referred to Sutherland Hospital Eye Clinic for diabetic retinopathy assessment
Triaged to the CFEH-TSH arm of the clinic for assessment within 4 weeks or longer
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant neurological or systemic co-morbidities that constitute an immediate medical or ophthalmic emergency, or need to be referred to other specialties or immediately admitted to hospital
Patients referred for diabetic retinopathy assessment with acute visual symptoms, unexplained of decreased visual acuity (6/9 or less), maculopathy within 2 optic disc diameter of the foveal centre, severe non-proliferative or any form of proliferative diabetic retinopathy, and all patients with urgent ophthalmic sign such as vitreous haemorrhage, retinal detachment or rubeotic glaucoma

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Descriptive analysis will be performed on all data collected in data collection forms B and C. Specific outcome measures (see also 4.10) will be calculated comparatively between control and intervention group including the appointment wait time based on the difference between date of the appointment and the referral. Corrections will be applied if appointments were delayed based on patient dependent factors (eg re-scheduling due to sickness, travel etc). Appointment wait times will be compared between the control and intervention cohort using 2 independent sample t-test.

Final diagnosis and recommended patient management will be recorded and proportions of patients not suitable for triage to the TSH-CFEH clinic based on examination outcomes will be calculated for each arm of the trail and compared applying a two-proportion z-test. False positive and negative rates will be calculated for all potentially vision threatening or severe conditions that require ophthalmological review either immediately or within up to one week. Additionally, the Wilcoxon signed ranks test will be used to assess changes in the proportion of appointments that required specialist ophthalmology attention over the course of the project.

Multivariate analysis will be applied to appointment wait time and time since last eye exam to quantify the effect of diabetes type, risk factors, known complications, presence and stage of diabetic retinopathy, blood test results, patients’ age and ethnicity on clinical services and access. Descriptive statistics will be applied to investigate patient satisfaction at either side using results from obtained survey data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9147 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 17658 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 297647 0
University
Name [1] 297647 0
Centre for Eye Health, Unversity of New South Wales
Address [1] 297647 0
The University of New South Wales
Rupert Myers Building (south wing)
Barker Street, Gate 14
Kensington NSW 2052
Country [1] 297647 0
Australia
Primary sponsor type
University
Name
Centre for Eye Health, Unversity of New South Wales
Address
The University of New South Wales
Rupert Myers Building (south wing)
Barker Street, Gate 14
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 296668 0
Hospital
Name [1] 296668 0
The Sutherland Hospital Eye Clinic
Address [1] 296668 0
Sutherland Hospital
Kingsway
Caringbah NSW 2229
Country [1] 296668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298733 0
SESLHD Human Research Ethics Committee
Ethics committee address [1] 298733 0
Research Support Office G71, East Wing Edmund Blacket Building Prince of Wales Hospital Randwick NSW 2031
Ethics committee country [1] 298733 0
Australia
Date submitted for ethics approval [1] 298733 0
10/11/2017
Approval date [1] 298733 0
08/06/2018
Ethics approval number [1] 298733 0
HREC/18/POWH/94

Summary
Brief summary
Vision related problems, commonly associated with increasing age and chronic disease burden, amount to $16 billion annual costs in Australia and challenge the provision of cost-effective, accessible, and timely care for patients with chronic disorders. Visual impairment and blindness as a consequence of diabetes have increased by 64% and 27% respectively worldwide between 1990 and 2010. In Australia, diabetes is the leading cause of blindness in working-age people. Referral refinement schemes and shared-care models have recently been implemented internationally to manage patients with glaucoma, and alternative care pathways for other conditions have been investigated. These models integrate optometrists in the care of patients with chronic stable conditions, or in need of long-term at-risk disease monitoring, thus effectively focusing specialist and hospital care for patients with urgent or complicated conditions.

TSH provides care to a large cohort of patients with diabetes, typically under the care of an endocrinologist, many currently do not receive appropriate levels of eye care. Patients also have access to an integrated care unit (HealthOne), which provides diabetes education, health and legal advice. In collaboration with CFEH, TSH recently established a hospital-based ophthalmology-optometry collaborative care clinic in Australia as part of this multidisciplinary team to make eye health care available to all patients with diabetes and support the development of integrated patient management between general practitioners, specialists and allied health professionals.

This study will investigate a novel hospital-based ophthalmology-optometry collaborative care model to prevent vision related complications in patients suffering from diabetes. Successful implementation of this model would not only reduce the incidence of sight-threatening diabetic retinopathy in Australia, but provide a foundation for the provision of sustainable, accessible, and efficient eye health care for patients with diabetes. To investigate the potential of this model within the current setting as well as its potential for implementation in other hospitals, we will assess:

• suitability of patients for shared care;
• clinical status and demographic characteristics of patient cohorts;
• patient satisfaction and quality of life;
• cost analysis of the new model.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78054 0
Dr Barbara Zangerl
Address 78054 0
Centre for Eye Health The University of New South Wales Rupert Myers Building (south wing) Barker St, Gate 14 Kensington NSW 2052
Country 78054 0
Australia
Phone 78054 0
+61 2 8115 0793
Fax 78054 0
+61 2 8115 0799
Email 78054 0
bzangerl@cfeh.com.au
Contact person for public queries
Name 78055 0
Dr Barbara Zangerl
Address 78055 0
Centre for Eye Health The University of New South Wales Rupert Myers Building (south wing) Barker St, Gate 14 Kensington NSW 2052
Country 78055 0
Australia
Phone 78055 0
+61 2 8115 0793
Fax 78055 0
+61 2 8115 0799
Email 78055 0
bzangerl@cfeh.com.au
Contact person for scientific queries
Name 78056 0
Dr Barbara Zangerl
Address 78056 0
Centre for Eye Health The University of New South Wales Rupert Myers Building (south wing) Barker St, Gate 14 Kensington NSW 2052
Country 78056 0
Australia
Phone 78056 0
+61 2 8115 0793
Fax 78056 0
+61 2 8115 0799
Email 78056 0
bzangerl@cfeh.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality reasons - only summary data will be shared
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable