Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001222336
Ethics application status
Approved
Date submitted
9/08/2017
Date registered
21/08/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating the impact of an alternative, shared-care pathway on waiting times for patients referred for eye examination to a public ophthalmology clinic
Scientific title
Effect of a Collaborative Ophthalmic System for Effective Triage (COSET) for patients referred to a public ophthalmology clinic on waiting times
Secondary ID [1] 292622 0
None
Universal Trial Number (UTN)
U1111-1200-4657
Trial acronym
COSET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eye health 304310 0
Condition category
Condition code
Eye 303664 303664 0 0
Diseases / disorders of the eye
Public Health 303687 303687 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients on the waiting list for "next available" appointment at the Prince of Wales Hospital (POWH) Eye Clinic associated with a current wait time of over 12 months, will be offered an alternative appointment at the Centre for Eye Health (CFEH) as part of an optometry-ophthalmology shared-care arrangement within 4-6 weeks.

The intervention will be delivered face to face in the form of a single clinical appointment at CFEH. Appointments will be delivered by specially trained, therapeutically endorsed optometrists and clinical data will be reviewed by an ophthalmologist from the POWH prior to completion of a clinical report and patient management recommendation. Duration most commonly will cover 1-2 hours, but exact time frame and procedures are personalised depending on the reason for referral for eye examination by the primary care provider.

All examinations will include physical inspection of the eye by an optometrist, visual acuity testing, and slit lamp examination. Other tests will be specific to the specific reason for referral and may include gonioscopy, measurement of the intraocular pressure, central corneal thickness, or visual function. Individual structures of the eye may be imaged using fundus photography, corneal topography, scheinpflug imaging, optical coherence tomography, autofluorescence imaging or ultrasound biomicroscopy.
Intervention code [1] 298843 0
Diagnosis / Prognosis
Comparator / control treatment
Patients on the waiting list for "next available" appointment at the Prince of Wales Hospital (POWH) Eye Clinic associated with a current wait time of over 12 months, will be enrolled in the clinical trial as control group.

The intervention will be delivered face to face in the form of a single clinical appointment delivered by ophthalmologists at the POWH Eye Clinic. Duration most commonly will cover 1-2 hours, but exact time frame and procedures are personalised depending on the reason for referral for eye examination by the primary care provider.

All examinations will include physical inspection of the eye by an ophthalmologist, visual acuity testing, and slit lamp examination. Other tests will be specific to the specific reason for referral and may include gonioscopy, measurement of the intraocular pressure, central corneal thickness, or visual function. Individual structures of the eye may be imaged using fundus photography, corneal topography, scheinpflug imaging, optical coherence tomography, autofluorescence imaging or ultrasound biomicroscopy.
Control group
Active

Outcomes
Primary outcome [1] 303029 0
T-test analysis of wait times, defined as difference between receipt of patient referral and eye examination appointment date) for patients referred for eye examination to the Prince of Wales Hospital Eye Clinic or the Centre for Eye Health obtained from medical records
Timepoint [1] 303029 0
two year after trial commencement
Primary outcome [2] 303030 0
T-test analysis to assess changes in the lead time between referrals received for eye examinations at the Prince of Wales Hospital Eye Clinic to establishing a patient care plan obtained from clinical records 6, 12, 18, and 24 months after trial commencement in comparison to baseline
Timepoint [2] 303030 0
Baseline, 6, 12, 18, and 24 months after trial commencement
Secondary outcome [1] 337722 0
Mann-Whitney U-test to assess proportion of appointments at the Prince of Wales Hospital Eye Clinic that do not require ophthalmology care obtained from clinical triage outcomes 6, 12, 18, and 24 months after trial commencement in comparison to baseline
Timepoint [1] 337722 0
baseline, 6, 12, 18, and 24 months after trial commencement

Eligibility
Key inclusion criteria
1) Valid referral for eye examination to the Prince of Wales Hospital Eye Clinic
2) Waiting for a "next available" appointment associated with current wait time of over 12 months in response to the referral
3) Suitable for a potential shared-care appointment as assessed by a senior ophthalmology trainee
4) Written, informed consent provided
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Insufficient information on the patient referral for appropriate triage
2) Patients with 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
3) Patients triaged for an appointment at the Prince of Wales Hospital Eye Clinic other than "next available"
4) No written, informed consent provided

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
Less than 10% of patients on the waiting list for "next available" appointment at the Prince of Wales Hospital Eye Clinic are seen within 12 months of receiving their referral. A decrease in wait time (and subsequently lead time to the patient care plan) from 90% to 50% would require 52 patients in each arm at a 99% confidence level at 99% power.

Increasing the sample size to 100 patients in each arm will allow us to calculate false positive and negative rates for potentially vision threatening or severe conditions that require ophthalmological review either immediately or within up to one week at 99% specificity and sensitivity with a confidence interval of 94.55% to 99.97.

Paired t-test will be applied to calculate the correlation between patient management initiated based on the initial referral and recommended based on patient outcome. 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
1/11/2017
Actual
19/01/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
18/12/2020
Date of last data collection
Anticipated
30/06/2020
Actual
30/04/2021
Sample size
Target
200
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8748 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 16868 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 297250 0
University
Name [1] 297250 0
Centre for Eye Health, Unversity of New South Wales
Country [1] 297250 0
Australia
Funding source category [2] 297331 0
Hospital
Name [2] 297331 0
Prince of Wales Hospital Eye Clinic
Country [2] 297331 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] 296221 0
Hospital
Name [1] 296221 0
Prince of Wales Hospital Eye Clinic
Address [1] 296221 0
Level 4, High Street Building,
The Prince of Wales Hospital,
High Street, Randwick,
Sydney, NSW 2031
Country [1] 296221 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298370 0
SESLHD Human Research Ethics Committee
Ethics committee address [1] 298370 0
Ethics committee country [1] 298370 0
Australia
Date submitted for ethics approval [1] 298370 0
11/08/2017
Approval date [1] 298370 0
13/12/2017
Ethics approval number [1] 298370 0

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

Contacts
Principal investigator
Name 76854 0
Dr Barbara Zangerl
Address 76854 0
Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 76854 0
Australia
Phone 76854 0
+61 2 8115 0793
Fax 76854 0
+61 2 8115 0799
Email 76854 0
bzangerl@cfeh.com.au
Contact person for public queries
Name 76855 0
Barbara Zangerl
Address 76855 0
Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 76855 0
Australia
Phone 76855 0
+61 2 8115 0793
Fax 76855 0
+61 2 8115 0799
Email 76855 0
bzangerl@cfeh.com.au
Contact person for scientific queries
Name 76856 0
Barbara Zangerl
Address 76856 0
Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 76856 0
Australia
Phone 76856 0
+61 2 8115 0793
Fax 76856 0
+61 2 8115 0799
Email 76856 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
only summary data will be shared due to patient confidentiality


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.