DiabetesNCT05074342
Project Open - Use of Administrative Health Data to Increase Diabetic Retinopathy Screening
An observational study of Diabetes and Diabetic Retinopathy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Early detection through regular diabetic retinopathy screening (DRS) is an effective method of preventing vision loss by enabling earlier intervention and timely treatment. It is recommended that all people with diabetes receive regular DRS, either annually or bi-annually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Retinopathy
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with type 1 or type 2 diabetes, who have attended a primary healthcare setting at CHCs, and through the use of provincial administrative data is identified as the patient who has not had their eyes screened within the past 425 days.
Who may be able to join
- At least 18 years of age
- Type 1 or type 2 diabetes as determined through linked provincial healthcare administrative datasets or primary care data using algorithms similar to provincial methods.
- Attended the primary health care setting, with at least 1 visit to the centre within the past 10 years
Who cannot join
- 1. Individuals identified as having received DRS (in the previous 425 days) by an ophthalmologist and/or optometrist or tele-ophthalmology/Tele-Retina.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Guiding Primary Care Diabetic Retinopathy Screening in Canada Through the Use of Provincial Healthcare Administrative Data
Early detection through regular diabetic retinopathy screening (DRS) is an effective method of preventing vision loss by enabling earlier intervention and timely treatment. It is recommended that all people with diabetes receive regular DRS, either annually or bi-annually. Current DRS practice in Canada, however, falls remarkably short of recommended DRS rates resulting in preventable vision loss.
In this project the investigators use population health-based approach to diabetes care. Linked provincial administrative data will be leveraged to consistently identify all those that have not had DRS in 425 days with the goal to improve outcomes, equity and potentially reduce the cost of care delivery.
Read the detailed description
Diabetic Retinopathy (DR) is the leading cause of blindness in working age Canadians. Canada fall remarkably short of this recommended rate resulting in many Canadians with preventable vision loss, despite the availability of ophthalmology and/or optometry services covered by provincial health insurance plans. It is estimated that in Ontario alone that up to 40% of individuals with diabetes have not had their eyes screened for retinopathy. To address the low rate, tele-ophthalmology or Tele-Retina, using telemedicine resources, has been an approach used in a variety of primary health care settings in urban, rural and remote areas across Canada. In the United Kingdom, a population-based approach to this issue have been taken and have lowered the unscreened rate, resulting in diabetic retinopathy no longer being the leading cause of blindness in working age individuals. New strategies are required to identify, engage, and provide ongoing monitoring to those requiring DR screening in Ontario.
The electronic medical records in doctors' offices do not receive information about the status of patients with diabetes retinopathy screening status. This information only exists through provincial data and public insurance system billings. Using administrative health data, the investigators developed a population-based approach to DR screening at community health centres (CHCs). Patients with diabetes who have not had DR screening in 425 days have been identified using linked provincial and community-based datasets.
Through the linking of the Alliance for Healthier Communities dataset with other Ontario healthcare administrative databases held at Institute for Clinical Evaluative Sciences (IC/ES), the investigators have identified clients within the CHC that have not had eyes checked for signs of retinopathy by an ophthalmologist or optometrist within the previous 425 days. This data is transferred to the CHC and the identified clients will then be called to let them know about the importance of having their eyes examined and to see if they are interested in participating in the study. Through the Diabetes Eye Screening Program, Tele-Retina will be made available through referral. If individuals are not interested in this program, patients will be encouraged to seek alternate ophthalmology or optometry services.
Qualitative semi-structured interviews examining diabetic retinopathy screening and the Tele-Retina process at the CHC, including facilitators and barriers towards diabetes care, specifically eye care, will be conducted. The investigators will be interviewing patients, caregivers, healthcare practitioners, CHC staff, management and policy decision-makers.
The intervention of providing provincial-level diabetic retinopathy status to primary health care settings will be evaluated using a mixed-methods implementation-effectiveness hybrid approach. Evaluation will be conducted concurrently with the study intervention to evaluate its effectiveness, cost-effectiveness, implementation barriers and key success factors. The evaluation will consist of 4 main components of 1) an implementation study, 2) a policy study, 3) clinical evaluation and 4) economic evaluation studies.
Our overall objectives for the study are to:
- Increase the number of screened individuals who are at risk for DR within the primary care settings, and to refer to treatment those at risk of vision loss;
- Evaluate implementation and policy barriers associated with the transfer and use of healthcare administrative data related to DR, at a primary care level and DR screening in general;
- Evaluate patient and provider experience and attitudes with the initiative, including sex and gender and socioeconomic factors;
- Describe the severity of diabetic retinopathy in those individuals who agree to be screened;
- Examine the healthcare resource utilization and costs and cost-effectiveness associated with the intervention.
- Conditions
- Diabetes, Diabetic Retinopathy
- Keywords
- Administrative data, Screening
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
The provision of a DRS status list to primary health care settings will increase the rate of annual DR screening in patients with type 1 or type 2 diabetes who have attended the centres.
To increase the screening rate of individuals who are at risk for DR within the primary care settings, and to refer to treatment those at risk of vision loss.
Measured: 425 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- South Riverdale Community Health Centre, Flemingdon Health Centre, Institute for Clinical Evaluative Sciences
- Responsible party
- Principal investigator, Michael Brent, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074342
- Sponsor's protocol ID
- 8 Sep 2020
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Primary Care Diabetic Retinopathy Screening in Canada Through the Use of Provincial Healthcare Administrative Data
- ClinicalTrials.gov ID
- NCT05074342
- Acronym / sponsor ID
- 8 Sep 2020
- Conditions
- Diabetes, Diabetic Retinopathy
- Keywords
- Administrative data, Screening
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- South Riverdale Community Health Centre, Flemingdon Health Centre, Institute for Clinical Evaluative Sciences
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early detection through regular diabetic retinopathy screening (DRS) is an effective method of preventing vision loss by enabling earlier intervention and timely treatment. It is recommended that all people with diabetes receive regular DRS, either annually or bi-annually. Current DRS practice in Canada, however, falls remarkably short of recommended DRS rates resulting in preventable vision loss.
In this project the investigators use population health-based approach to diabetes care. Linked provincial administrative data will be leveraged to consistently identify all those that have not had DRS in 425 days with the goal to improve outcomes, equity and potentially reduce the cost of care delivery.
Detailed description
Diabetic Retinopathy (DR) is the leading cause of blindness in working age Canadians. Canada fall remarkably short of this recommended rate resulting in many Canadians with preventable vision loss, despite the availability of ophthalmology and/or optometry services covered by provincial health insurance plans. It is estimated that in Ontario alone that up to 40% of individuals with diabetes have not had their eyes screened for retinopathy. To address the low rate, tele-ophthalmology or Tele-Retina, using telemedicine resources, has been an approach used in a variety of primary health care settings in urban, rural and remote areas across Canada. In the United Kingdom, a population-based approach to this issue have been taken and have lowered the unscreened rate, resulting in diabetic retinopathy no longer being the leading cause of blindness in working age individuals. New strategies are required to identify, engage, and provide ongoing monitoring to those requiring DR screening in Ontario.
The electronic medical records in doctors' offices do not receive information about the status of patients with diabetes retinopathy screening status. This information only exists through provincial data and public insurance system billings. Using administrative health data, the investigators developed a population-based approach to DR screening at community health centres (CHCs). Patients with diabetes who have not had DR screening in 425 days have been identified using linked provincial and community-based datasets.
Through the linking of the Alliance for Healthier Communities dataset with other Ontario healthcare administrative databases held at Institute for Clinical Evaluative Sciences (IC/ES), the investigators have identified clients within the CHC that have not had eyes checked for signs of retinopathy by an ophthalmologist or optometrist within the previous 425 days. This data is transferred to the CHC and the identified clients will then be called to let them know about the importance of having their eyes examined and to see if they are interested in participating in the study. Through the Diabetes Eye Screening Program, Tele-Retina will be made available through referral. If individuals are not interested in this program, patients will be encouraged to seek alternate ophthalmology or optometry services.
Qualitative semi-structured interviews examining diabetic retinopathy screening and the Tele-Retina process at the CHC, including facilitators and barriers towards diabetes care, specifically eye care, will be conducted. The investigators will be interviewing patients, caregivers, healthcare practitioners, CHC staff, management and policy decision-makers.
The intervention of providing provincial-level diabetic retinopathy status to primary health care settings will be evaluated using a mixed-methods implementation-effectiveness hybrid approach. Evaluation will be conducted concurrently with the study intervention to evaluate its effectiveness, cost-effectiveness, implementation barriers and key success factors. The evaluation will consist of 4 main components of 1) an implementation study, 2) a policy study, 3) clinical evaluation and 4) economic evaluation studies.
Our overall objectives for the study are to:
- Increase the number of screened individuals who are at risk for DR within the primary care settings, and to refer to treatment those at risk of vision loss;
- Evaluate implementation and policy barriers associated with the transfer and use of healthcare administrative data related to DR, at a primary care level and DR screening in general;
- Evaluate patient and provider experience and attitudes with the initiative, including sex and gender and socioeconomic factors;
- Describe the severity of diabetic retinopathy in those individuals who agree to be screened;
- Examine the healthcare resource utilization and costs and cost-effectiveness associated with the intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with type 1 or type 2 diabetes, who have attended a primary healthcare setting at CHCs, and through the use of provincial administrative data is identified as the patient who has not had their eyes screened within the past 425 days.
Key inclusion criteria (3 listed)
- At least 18 years of age
- Type 1 or type 2 diabetes as determined through linked provincial healthcare administrative datasets or primary care data using algorithms similar to provincial methods.
- Attended the primary health care setting, with at least 1 visit to the centre within the past 10 years
Key exclusion criteria (1 listed)
- 1. Individuals identified as having received DRS (in the previous 425 days) by an ophthalmologist and/or optometrist or tele-ophthalmology/Tele-Retina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The provision of a DRS status list to primary health care settings will increase the rate of annual DR screening in patients with type 1 or type 2 diabetes who have attended the centres.
Time frame: 425 days
To increase the screening rate of individuals who are at risk for DR within the primary care settings, and to refer to treatment those at risk of vision loss.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Retinopathy, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The provision of a DRS status list to primary health care settings will increase the rate of annual DR screening in patients with type 1 or type 2 diabetes who have attended the centres. (time frame: 425 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.