ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001420336

Ethics application status

Approved

Date submitted

29/09/2017

Date registered

9/10/2017

Date last updated

22/10/2021

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]

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

Condition category

Condition code

Eye

Diseases / disorders of the eye

Public Health

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]

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]

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]

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]

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]

At the conclusion of the project, once target size (200 patients) is reached

Secondary outcome [1]

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]

At the conclusion of the project, once target size (200 patients) is reached

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

19/03/2018

Actual

31/10/2018

Date of last participant enrolment

Anticipated

30/10/2020

Actual

29/02/2020

Date of last data collection

Anticipated

30/10/2020

Actual

29/02/2020

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Sutherland Hospital - Caringbah

Recruitment postcode(s) [1]

2229 - Caringbah

Funding & Sponsors

Funding source category [1]

University

Name [1]

Centre for Eye Health, Unversity of New South Wales

Address [1]

The University of New South Wales
Rupert Myers Building (south wing)
Barker Street, Gate 14
Kensington NSW 2052

Country [1]

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]

Hospital

Name [1]

The Sutherland Hospital Eye Clinic

Address [1]

Sutherland Hospital
Kingsway
Caringbah NSW 2229

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SESLHD Human Research Ethics Committee

Ethics committee address [1]

Research Support Office G71, East Wing Edmund Blacket Building Prince of Wales Hospital Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/11/2017

Approval date [1]

08/06/2018

Ethics approval number [1]

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

Dr Barbara Zangerl

Address

Centre for Eye Health The University of New South Wales Rupert Myers Building (south wing) Barker St, Gate 14 Kensington NSW 2052

Country

Australia

Phone

+61 2 8115 0793

Fax

+61 2 8115 0799

bzangerl@cfeh.com.au

Contact person for public queries

Name

Barbara Zangerl

Address

Centre for Eye Health The University of New South Wales Rupert Myers Building (south wing) Barker St, Gate 14 Kensington NSW 2052

Country

Australia

Phone

+61 2 8115 0793

Fax

+61 2 8115 0799

bzangerl@cfeh.com.au

Contact person for scientific queries

Name

Barbara Zangerl

Address

Centre for Eye Health The University of New South Wales Rupert Myers Building (south wing) Barker St, Gate 14 Kensington NSW 2052

Country

Australia

Phone

+61 2 8115 0793

Fax

+61 2 8115 0799

bzangerl@cfeh.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Confidentiality reasons - only summary data will be shared

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically