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

Diabetes Mellitus, Type 2 Clinical Trial

— TOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03927859
• Other study ID #: 2018-0068-E
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: April 2019
• Source: Women's College Hospital
• Contact: Vess Stamenova, PhD
• Phone: 416-323-6400
• Email: vess.stamenova[@]wchospital.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: August 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Other:
• a 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.

Locations

Country	Name	City	State
Canada	Black Creek Community Health Centre	Toronto	Ontario
Canada	Women's College Hospital Family Health Team	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Women's College Hospital	Canadian Institutes of Health Research (CIHR), Diabetes Action Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bookings made through the TOP program	The primary outcome for the study is the number of bookings made through the TOP program	1 year
Secondary	Number of self-reported booking made outside of TOP	Secondary outcomes include the number of self-reported booking made outside of TOP	1 year