Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05074342 |
| Other study ID # |
8 Sep 2020 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University Health Network, Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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:
1. 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;
2. 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;
3. Evaluate patient and provider experience and attitudes with the initiative, including
sex and gender and socioeconomic factors;
4. Describe the severity of diabetic retinopathy in those individuals who agree to be
screened;
5. Examine the healthcare resource utilization and costs and cost-effectiveness associated
with the intervention.
