NCT05773495

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,840

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Mar 2024Dec 2028

First Submitted

Initial submission to the registry

March 2, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

March 2, 2023

Last Update Submit

February 12, 2026

Conditions

Diabetic Retinopathy

Keywords

screening

Outcome Measures

Primary Outcomes (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.

    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)

  • Monthly Teleophthalmology Use

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

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

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

Study Arms (1)

Usual Care Followed by I-SITE Intervention

EXPERIMENTAL
Other: I-SITE InterventionOther: Usual Care Teleophthalmology

Interventions

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 Followed by I-SITE Intervention
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.

Usual Care Followed by I-SITE Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Yao Liu, MD, MS

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 17, 2023

Study Start

March 19, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Time Frame
up to 7 years after the completion of the primary outcome
Access Criteria
contact study PI for access

Locations

US(1)