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Diabetic RetinopathyNCT05773495

Implementation of Teleophthalmology in Urban Health Systems Study

A study testing I-SITE Intervention in people with Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is being conducted to test the effectiveness of I-SITE (Implementation for Sustained Impact in Teleophthalmology), an implementation program to sustain increased diabetic eye screening rates using teleophthalmology in urban, multi-payer health systems. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy
What is being tested?
I-SITE Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,840 participants
Where
1 siteUnited States
Study dates
19 Mar 2024to 31 Dec 2028
Phase
Interventional
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

Who may be able to join

  • Eligible medical records will be identified using ICD-10 codes for diabetes type 1 or type 2
  • Billing data will be identified using teleophthalmology (CPT codes 92228 or 92250)
  • Identification of eligible records will be performed by clinic personnel at each health system who already have full access to their patient data as part of their employment, and regularly gather and report this type of data to health insurers as part of their clinical role

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

This study is being conducted to test the effectiveness of I-SITE (Implementation for Sustained Impact in Teleophthalmology), an implementation program to sustain increased diabetic eye screening rates using teleophthalmology in urban, multi-payer health systems.

Read the detailed description

The goal is to adapt I-SITE to a new population by identifying and testing strategies to overcome key barriers to teleophthalmology use among Latinos and Black Americans with diabetes.

The investigators will develop and test a culturally-adapted I-SITE intervention in urban, federally-qualified health centers serving low-income, Black and Latinx communities. The primary hypothesis is that the intervention will significantly increase the diabetic eye screening rate (primary outcome) at Access CHC and Outreach CHC at 6- and 12-months post-implementation compared to baseline. Secondary outcomes include monthly teleophthalmology use and follow-up rates for in-person eye care among screen positives. These data will facilitate rapid dissemination by helping key decision makers, such as health system administrators, determine whether to adopt the culturally-adapted I-SITE intervention.

The investigators are using a pre-post study design at each health system (site) to compare: (1) usual care teleophthalmology vs. the (2) I-SITE intervention.

  1. Usual Care Teleophthalmology: All sites will initially receive usual care teleophthalmology, consisting of having an active teleophthalmology program located in the primary care clinic and access to the I-SITE online toolkit. The I-SITE online toolkit has been freely-available since December 2019 to all U.S. health systems and the general public. Health systems may also contact the study team for assistance with technical issues. All sites will utilize non-mydriatic retinal cameras (e.g. Topcon NW400) located in their primary care clinic to obtain a single 45-degree photo of the disc and macula with an anterior photo in each eye to provide diabetic eye screening as part of patients' usual care. Images are captured by trained primary care personnel and securely transmitted to eye doctors for evaluation. This workflow is based on existing protocols and guidelines set by the American Telemedicine Association Practice Recommendations for Diabetic Retinopathy.
  2. I-SITE Intervention: Each site will subsequently receive all elements of usual care teleophthalmology plus the I-SITE implementation program. I-SITE is a coaching facilitated implementation program that guides clinical personnel through tailored integration of teleophthalmology into primary care workflows.

The I-SITE intervention includes:

  • Initial 30-minute live webinar introduction and question \& answer session between the I-SITE Coach and the participating primary care clinics.
  • Two in-person 1-hour meetings between the I-SITE Coach and the local clinic team to discuss the teleophthalmology workflow, review current teleophthalmology use, diabetic eye screening rates, follow-up rates for in-person eye care among screen positives, set goals, and select implementation strategies to test. The meetings are to occur within 6 weeks after the introductory webinar.
  • A series of 10 monthly teleconferences (15-30 min.) following the in-person meetings where the I-SITE Coach and local clinic team test and refine implementation strategies by reviewing data and providing feedback.

Two I-SITE Coaches will be present at all meetings (i.e., lead and assistant coach) to ensure continuity in case the lead I-SITE Coach is unexpectedly unable to attend a meeting.

I-SITE Coaches will also perform a half-day, on-site visit to physically walkthrough the teleophthalmology workflow, as well as meet with clinic administrators and staff, on the date of the first in-person meeting.

Data Collection Procedures:

Patient data will be collected within the established electronic health record at each participating health system as part of routine patient care, de-identified, and exported for secondary data analysis by clinic personnel at each health system who already have full access to their patient data as part of their employment, and regularly gather and report this type of data to health insurers as part of their clinical role (e.g., clinical quality improvement and electronic health record/information technology staff ). Personnel from each participating health system will only have access to data from their own health system.

Being tested
I-SITE Intervention, Usual Care Teleophthalmology
Keywords
screening
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-SITE InterventionOther

    I-SITE is a coaching facilitated implementation program that guides clinical personnel through tailored integration of teleophthalmology into primary care workflows.

  • Usual Care TeleophthalmologyOther

    All sites will initially receive usual care teleophthalmology, consisting of having an active teleophthalmology program located in the primary care clinic and access to the I-SITE online toolkit. All sites will utilize non-mydriatic retinal cameras (e.g. Topcon NW400) located in their primary care clinic to obtain a single 45-degree photo of the disc and macula with an anterior photo in each eye to provide diabetic eye screening as part of patients' usual care. Images are captured by trained primary care personnel and securely transmitted to eye doctors for evaluation.

Study groups in NCT05773495
Study groupRoleWhat they receive
Usual Care Followed by I-SITE InterventionExperimentalNot described
Receives: Other: I-SITE Intervention; Other: Usual Care Teleophthalmology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Diabetic Screening Rate

    Proportion of patients with diabetes with medical record documentation of diabetic eye screening within the last 12 months among patients with type 1 or type 2 diabetes who had at least 2 clinic visits with primary care provider within the past 24 months.

    Measured: baseline (data is retrospective to evaluate pre-intervention beginning November 2022), 6 months post-intervention (up to 18 months), 12 months post-intervention (up to 24 months)

Secondary outcomes (2)
  1. Monthly Teleophthalmology Use

    Monthly number of patients for whom an eye photo was ordered and for whom an eye photo was completed

    Measured: data collected monthly (retrospectively beginning November 2022 and up to 36 months prospectively)

  2. Follow Up Rate For In-Person Eye Care Among Screen Positives

    Comparison of follow-up rates for in-person eye care among patients who have screened positive for ocular pathology requiring further in-person eye care on their teleophthalmology photos and subsequently obtained an in-person dilated eye exam with an eye care provider within 1 year of their teleophthalmology visit based on medical records review.

    Measured: baseline (data is retrospective to evaluate pre-intervention beginning November 2022) and 12, 24, and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start19 Mar 2024
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
12,840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773495
Sponsor's protocol ID
2023-0019
Other IDs
Ophthalmology, 1UG1EY032446
Status last verified
Feb 2026
First submitted
2 Mar 2023
Last updated
13 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data regarding patient demographics, whether they obtained diabetic eye screening, had teleophthalmology performed, any vision-threatening eye condition identified by teleophthalmology, and whether they followed-up for in-person eye care if they screened positive will be available to share.

Questions about this trial

What is this clinical trial studying?

A study testing I-SITE Intervention in people with Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.

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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. 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 United States. 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?

Change in Diabetic Screening Rate (time frame: baseline (data is retrospective to evaluate pre-intervention beginning November 2022), 6 months post-intervention (up to 18 months), 12 months post-intervention (up to 24 months)). 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 13 Feb 2026.

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