Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000076774
Ethics application status
Approved
Date submitted
8/12/2021
Date registered
21/01/2022
Date last updated
21/01/2022
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
iCareTracking: Optimising the appropriateness of glaucoma and diabetic eyecare delivery by Australian optometrists
Scientific title
iCareTracking: Implementing the i-ACT (iCareTrack Assessment of appropriateness Clinical practice Tool) intervention aiming to optimise the appropriateness of glaucoma and diabetic eyecare delivery by Australian optometrists
Secondary ID [1] 305976 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 324593 0
Diabetic eye disease 324594 0
Condition category
Condition code
Eye 322050 322050 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 322208 322208 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a quality improvement program for optometrists that will be delivered over a 3-month period. The program is comprised of the clinical self-assessment (self-audit of clinical records), peer support activities, education activities and resources. There are three arms to the trial (1) Glaucoma (2) Diabetic eye disease (3) control. Both the glaucoma and diabetic eye disease arms are intervention groups. The clinical self-assessment is delivered online via the iCareTrack Assessment of appropriateness Clinical practice Tool (i-ACT).
The i-ACT consists of 45 and 33 clinical indicators (measurable components of guideline recommendations with inclusion criteria and compliance action) for glaucoma and diabetic eye disease, respectively. The clinical indicators are stratified by the domains of history taking, physical examinations, management, recall and referral. Optometrists will access the secure online portal to complete their self-assessment. Optometrists will complete at least three i-ACT cycles of self-assessment of the appropriateness of care delivery (entry, mid-point, and final). The self-assessments will occur at the following timepoints: entry (within week 1 to week 2 of the intervention period), mid-point (within week 6 to week 7), and final (within week 11 to week 12). A minimum of ten patient records will be assessed in each cycle taking approximately 2 hours/cycle. At the end of each self-assessment cycle, feedback will be provided. Feedback will be the overall and domain appropriateness percentages for their assessment which will be benchmarked to both normative and realistic benchmarks. Adherence to i-ACT self-assessment cycles will be monitored via web-portal analytics. For peer support, optometrists will participate in a minimum of one of the three offered condition-specific interactive case study webinars facilitated by the researchers with subject matter experts (either ophthalmologists or optometrists) presenting the case studies. Thus, participants in the glaucoma arm will attend one of three offered glaucoma case study webinars and participants in the diabetes arm will attend one of three offered diabetic eye disease case study webinars. The duration of each webinar is one hour. One webinar per condition (i.e., one glaucoma and one diabetes) will be offered every month during the intervention period. The webinars will be interactive, with participants able to participate in the discussion. Adherence to webinar participation will be monitored by registration and attendance logs.
Educational activities comprise of video lectures and case studies on appropriate glaucoma and diabetic eyecare available on the online portal. These educational activities have been specifically designed for the study. Resources consist of a combination of those designed specifically for the study (e..g., checklists, risk factor lists) as well as URL links to external resources. External sources for Diabetes : (1) Centre for Eye Health Chair-Side Reference Diabetic Retinopathy, (2) Optometry Australia Clinical Guidelines for Examination and Management of Patients with Diabetes, (3) University of Melbourne Diabetic Grading course https://drgrading.iehu.unimelb.edu.au/cera/index.asp) (4) Eye Can Do it Patient Education (https://www.eyecandoit.org/EYECanDoIt.pdf): External sources for Glaucoma: (1) Optometry Australia Clinical Practice Guide for Diagnosis and management of Open-Angle Glaucoma, (2) RANZCO Clinical Practice Guidelines for the Collaborative Care of glaucoma patients and suspects by ophthalmologists and optometrists in Australia, (3) GONE Project (http://www.gone-project.com/), and (4) Glaucoma Australia Collaborative Care Referral Response Pathway (https://glaucoma.org.au/i-treat-glaucoma). Both the educational activities and resources are optional activities that the optometrists will access as required. Regardless of group allocation (intervention or control), at the completion of the intervention, an external assessor will conduct an assessment of your clinical records for patients with diabetes and/or patients with or at risk of glaucoma. For the intervention groups, a minimum of twenty (20) records of either diabetic patients or patients with or at risk of glaucoma (depending on their allocation) will be randomly sampled and assessed (minimum of 10 clinical records from a 4-week period prior to the intervention start date and a minimum of 10 clinical records from the 4-week period after intervention completion.
Intervention code [1] 322371 0
Behaviour
Comparator / control treatment
The control group will not receive any placebo or sham intervention. However, participants allocated to the control group will be given access to the iCareTracking portal at the completion of data collection to access the i-ACT, educational activities and resources. Regardless of group allocation (intervention or control), at the completion of the intervention an external assessor will conduct an assessment of the partcipant's clinical records for patients with diabetes and/or patients with or at risk of glaucoma. For the control group, a minimum of twenty (20) records for both diabetic patients or patients with or at risk of glaucoma will be randomly sampled and assessed (minimum of 10 diabetes and a minimum of 10 glaucoma clinical records from within a 4-week period prior to intervention start date and a minimum of 10 diabetes and 10 glaucoma clinical records from the 4-week period after intervention completion
Control group
Active

Outcomes
Primary outcome [1] 329809 0
The efficacy of the intervention package will be assessed in the intervention group and compared to the control group for pre-and-post appropriateness of glaucoma care delivery through external assessment of clinical care. This will be achieved by retrospective patient clinical record audit. The measure to assess efficacy will be the appropriateness of glaucoma and diabetic eyecare delivery. Condition level appropriateness will be calculated for both glaucoma and diabetic eyecare. Appropriateness is measured as the percentage of eligible encounters at which the clinical indicator is met.
Timepoint [1] 329809 0
The retrospective clinical record audit will commence one month after the completion of the intervention period. For the pre-intervention audit, clinical records will be retrospectively sampled from the 4-week period prior to the intervention start date, For the post-intervention audit, clinical records will be retrospectively sampled from the 4-week period after the completion of the intervention period.
Primary outcome [2] 330032 0
The efficacy of the intervention package will be assessed in the intervention group and compared to the control group for pre-and-post appropriateness of diabetic eyecare delivery through external assessment of clinical care. This will be achieved by retrospective patient clinical record audit. The measure to assess efficacy will be the appropriateness of diabetic eyecare delivery. Appropriateness is measured as the percentage of eligible encounters at which the clinical indicator is met.
Timepoint [2] 330032 0
The retrospective clinical record audit will commence one month after the completion of the intervention period. For the pre-intervention audit, clinical records will be retrospectively sampled from the 4-week period prior to the intervention start date, For the post-intervention audit, clinical records will be retrospectively sampled from the 4-week period after the completion of the intervention period.
Secondary outcome [1] 403910 0
The efficacy of the iCareTrack Assessment of appropriateness in Clinical practice Tool (i-ACT) for glaucoma eyecare.
Online self-assessments of clinical care through i-ACT will be used to assess the efficacy of the intervention through a pre-and post-intervention assessment of appropriateness of glaucoma eyecare delivery. Appropriateness is the percentage of eligible encounters that meet the clinical indicators.
Timepoint [1] 403910 0
Participants will engage in a minimum of 3 i-ACT cycles (entry, mid-point, final) across the 12-week intervention trial period. The efficacy will be calculated from the entry and final i-ACT cycles. The entry i-ACT cycle must be completed within 2 weeks of commencing the intervention and the final i-ACT cycle must be completed in the last 2 weeks of the intervention period.
Secondary outcome [2] 404691 0
The efficacy of the iCareTrack Assessment of appropriateness in Clinical practice Tool (i-ACT) for diabetic eyecare.
Online self-assessments of clinical care through i-ACT will be used to assess the efficacy of the intervention through a pre-and post-intervention assessment of appropriateness of diabetic eyecare delivery. Appropriateness is the percentage of eligible encounters that meet the clinical indicators.
Timepoint [2] 404691 0
Participants will engage in a minimum of 3 i-ACT cycles (entry, mid-point, final) across the 12-week intervention period. The efficacy will be calculated from the entry and final i-ACT cycles. The entry i-ACT cycle must be completed within 2 weeks of commencing the intervention and the final i-ACT cycle must be completed in the last 2 weeks of the intervention period.

Eligibility
Key inclusion criteria
1. Optometrists registered to practice in Australia and provide care for people with diabetes and people with or at risk of glaucoma
2. Optometrists in full-time employment at one practice location (i.e., greater than 35 hours/week worked in the one practice location)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Optometrists providing care in settings other than community primary optometry or ophthalmology practice (e.g., hospital settings, outreach clinics, university teaching clinics)
2. Locum optometrists

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)
Allocation will involve contacting the holder of the allocation schedule who is not a part of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary study participants will be optometrists clustered by optometry practice. The total sample size to be recruited for the project is 70 optometry practices (average 140 optometrists). The sample size was estimated using a 3-Level Hierarchical Design (Level-3 Randomization) procedure in PASS 2020, v20.0.3 with an average of 2 practitioners per optometry practice, and an average of 10 patients per practitioner. Parameters for the procedure were calculated by fitting a three-level hierarchical model to pilot data for each of glaucoma and diabetes interventions (Ahn, Heo and Zhang, 2015). An alpha level of 0.025 was used to allow a shared control group for the two experiments. With a shared control group, 22 optometry practices for the control and glaucoma groups and 15 optometry practices in the diabetes group will provide at least 90% power to detect the desired effect sizes. To account for drop-out, the sample size was adjusted by 20% to give final sample size of 70 practices.

For both primary and secondary outcomes, descriptive statistics (means, standard deviations) and regression analysis (univariate and multivariate) will be used to analyse the data to identify predictive factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21299 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 36164 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 310316 0
Charities/Societies/Foundations
Name [1] 310316 0
Diabetes Australia
Country [1] 310316 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Dr Ted Rohr
University of New South Wales (UNSW), Sydney
High St
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 311463 0
None
Name [1] 311463 0
Address [1] 311463 0
Country [1] 311463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309979 0
HREC B UNSW Sydney
Ethics committee address [1] 309979 0
Ethics committee country [1] 309979 0
Australia
Date submitted for ethics approval [1] 309979 0
04/11/2021
Approval date [1] 309979 0
17/12/2021
Ethics approval number [1] 309979 0
HC210928

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

Contacts
Principal investigator
Name 116058 0
A/Prof Isabelle Jalbert
Address 116058 0
UNSW Sydney
Room 3.029,
Level 3 North Wing, Rupert Myers Building
Baker St
Kensington, NSW 2052
Country 116058 0
Australia
Phone 116058 0
+61 2 9385 7692
Fax 116058 0
Email 116058 0
[email protected]
Contact person for public queries
Name 116059 0
Melinda Toomey
Address 116059 0
UNSW Sydney,
Room 3.043
Level 3, Rupert Myers Building
Baker St
Kensington, NSW 2052
Country 116059 0
Australia
Phone 116059 0
+61 2 9348 0798
Fax 116059 0
Email 116059 0
[email protected]
Contact person for scientific queries
Name 116060 0
Melinda Toomey
Address 116060 0
UNSW Sydney,
Room 3.043
Level 3, Rupert Myers Building
Baker St
Kensington, NSW 2052
Country 116060 0
Australia
Phone 116060 0
+61 2 9348 0798
Fax 116060 0
Email 116060 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
A proviso of the waiver of consent for access to patient clinical records for the clinical audit conducted by researchers was that data would not be shared or used for purposes other than what was stated in the ethics application.


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.