Clinical trial NCT03927859: Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario
Official title: Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Diabetes Action Canada
First posted: 2019-04-25
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of bookings made through the TOP program
timeFrame: 1 year
Secondary outcomes:
measure: Number of self-reported booking made outside of TOP
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Black Creek Community Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital Family Health Team
state: Ontario
Study officials:
affiliation: University Health Network, Toronto Western Hospital
name: Michael H Brent, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Onil Bhattacharyya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Laura Desveaux, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Vess Stamenova, PhD
role: PRINCIPAL_INVESTIGATOR
References: