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Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario

Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03927859
Acronym
TOP
Enrollment
420
Registered
2019-04-25
Start date
2018-07-05
Completion date
2019-08-30
Last updated
2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

It is recommended that people with diabetes have their eyes screened for retinopathy every 1-2 years. Retinopathy can lead to visual impairment and blindness, but early detection through regular retinal screening can help to prevent this. Many Ontarians with diabetes have not been receiving regular screening. One possible way to get more people screened for retinopathy involves tele-retinal screening using teleophthalmology (TOP), where patients can have their eyes screened in their local clinic or a site nearby. In this project, we are testing 3 patient interventions: mailing a letter, phone call or an option to bundle their screening with other diabetic care services (e.g. foot care exam) and examine the impact of these various interventions alone or in combination with each other.

Detailed description

Currently in Ontario, about a third of patients with diabetes, or more than 400,000 individuals, have not had their screening done within the last two years. The rates are even lower if you examine screening rates within the last year. Within Ontario, the highest rates of unscreened individuals live in the Greater Toronto Area (Toronto Central Local Health Integration Network (LHIN), Central LHIN and Central West LHIN). Despite the recommendation for patients to be screened every year, currently only about 5% of patients in TCLHIN and CLHIN have been screened within the last year based on a preparatory analysis for this study. It is, therefore, important to identify which intervention strategies, or combination of strategies, will be most effective in improving screening rates in Ontario. While many studies have examined the effects of various strategies individually, for this project we aim to use several interventions that have been identified in the past as being effective and examine the effects of these interventions alone or in combination. The approach we are taking in this study is the Multiphase Optimization Strategy (MOST). This study design approach consists of three stages: a screening phase, a refining phase and a confirming phase. During the screening phase, several intervention approaches are evaluated alone or in combination with each other in order to assess which intervention(s) have the greatest potential for impact on the selected outcome. During the refining phase of MOST, the selected components are fine-tuned and issues such as optimal levels of each component are investigated. During the confirming phase, the selected components are delivered at optimal levels and the intervention showing greatest promise is evaluated through a standard randomized controlled trial.

Interventions

OTHERa mail letter, a phone call and a phone call plus mailed letter

All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present. Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Diabetes Action Canada
CollaboratorUNKNOWN
Women's College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This is a Multiphase Optimization Strategy (MOST) trial. All patients will be randomized to one of 4 (or 3 for one of the sites) intervention conditions in a fractional factorial design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Only patients diagnosed with Type I or Type II Diabetes with no evidence in their medical records of a screening within the last 2 years will be included in the study and only individuals 18 years of age or older will be included.

Exclusion criteria

Patients screened within the last year. In addition, individuals who cannot speak English will be excluded from the study to minimize additional workload placed on administrative staff.

Design outcomes

Primary

MeasureTime frameDescription
Number of bookings made through the TOP program1 yearThe primary outcome for the study is the number of bookings made through the TOP program

Secondary

MeasureTime frameDescription
Number of self-reported booking made outside of TOP1 yearSecondary outcomes include the number of self-reported booking made outside of TOP

Countries

Canada

Contacts

Primary ContactVess Stamenova, PhD
vess.stamenova@wchospital.ca416-323-6400
Backup ContactNike Onabajo, MSc
nike.onabajo@wchospital.ca4163236400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026