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Project Open - Use of Administrative Health Data to Increase Diabetic Retinopathy Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05074342
Recruitment Status : Not yet recruiting
First Posted : October 12, 2021
Last Update Posted : October 25, 2021
South Riverdale Community Health Centre
Flemingdon Health Centre
Parkdale Queen West Community Health Centre
Institute for Clinical Evaluative Sciences
Information provided by (Responsible Party):
Michael Brent, University Health Network, Toronto

Brief 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. 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.

Condition or disease
Diabetes Diabetic Retinopathy

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guiding Primary Care Diabetic Retinopathy Screening in Canada Through the Use of Provincial Healthcare Administrative Data
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  1. At least 18 years of age
  2. Type 1 or type 2 diabetes as determined through linked provincial healthcare administrative datasets or primary care data using algorithms similar to provincial methods.
  3. Attended the primary health care setting, with at least 1 visit to the centre within the past 10 years

Exclusion Criteria:

1. Individuals identified as having received DRS (in the previous 425 days) by an ophthalmologist and/or optometrist or tele-ophthalmology/Tele-Retina.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05074342

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Contact: Olivera Sutakovic, MD 416-603-5800 ext 5125
Contact: Jim Bowen, BScPhm, MSc, RPh 416-634-8261

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Canada, Ontarioa
University Health Network
Toronto, Ontarioa, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
South Riverdale Community Health Centre
Flemingdon Health Centre
Parkdale Queen West Community Health Centre
Institute for Clinical Evaluative Sciences
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Responsible Party: Michael Brent, MD, FRCSC Principal Investigator -Clinical Lead, University Health Network, Toronto Identifier: NCT05074342    
Other Study ID Numbers: 8 Sep 2020
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Brent, University Health Network, Toronto:
Administrative data
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases