An interventional study of I-SITE in Diabetic Retinopathy, sponsored by University of Wisconsin, Madison. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research
This pragmatic clinical trial 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 rural, multi-payer health systems. Up to 10 rural health systems providing teleophthalmology to 10,000 patients with diabetes and 100 clinical care personnel participating in the I-SITE intervention will be enrolled for up to 48 months.
The investigators' long-term goal is to reduce vision loss nationwide through widespread teleophthalmology use. The next step in the project is to determine whether I-SITE is an effective, generalizable strategy across multiple rural health systems.
The investigators will test the primary hypothesis that I-SITE will sustain significant diabetic eye screening rate increases of ≥ 20% (e.g., from 40% to ≥ 60%) compared to baseline. The primary outcome measure will be the change in diabetic eye screening rates between baseline and 24 months after initiation of I-SITE implementation. Secondary outcome measures include characterizing pre/post changes in screening rates at 12, 36, and up to 48 months after I-SITE implementation at all sites, follow-up rates for in-person eye care among screen positives, identifying key factors and core implementation components distinguishing high and low teleophthalmology-use health systems following I-SITE implementation, and measuring implementation costs.
I-Site implementation will include:
Aim 1: To test the effectiveness of I-SITE vs. usual care teleophthalmology for increasing diabetic eye screening rates among 10 rural health systems across 6 states. The investigators will use a cluster-randomized study design with a stepped wedge initiation of the intervention to optimize longitudinal assessment of sustained increases in diabetic eye screening rates up to 48 months. The investigators will also measure follow-up rates for in-person eye care among screen positives every 6 months.
Aim 2: To identify key factors and core implementation components that distinguish high and low teleophthalmology-use rural health systems after I-SITE implementation. The investigators will use an explanatory mixed methods design, including interviews with clinicians and health system personnel, to identify workflow strategies, organizational factors, and implementation components that determine the effectiveness of I-SITE implementation.
Aim 3: To determine implementation costs of I-SITE. The investigators will measure implementation costs from a health system perspective, including health system personnel time tracked using structured activity logs.
773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's planned enrollment of 10 is below the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Exclusion Criteria:
Up to 10 rural health systems will be participating in I-SITE implementation with cluster-randomization of the order of initiation for the intervention. All sites will receive usual care teleophthalmology prior to I-SITE implementation.
Other: I-SITE
I-SITE includes coaching facilitation, technical assistance, and an online toolkit to allow primary care clinics to tailor the integration of teleophthalmology into their daily workflows based on each clinic's unique needs and resources. The program includes a series of coaching sessions between a skilled practice facilitator and clinical personnel at each health system.
Also known as: Implementation for Sustained Impact in Teleophthalmology
Proportion of Patients Who Complete Annual Diabetic Eye Screening
Comparison of proportion of patients with diabetes adherent with yearly diabetic eye screening guidelines (i.e., "screening rates") between baseline and 24 months following initiation of I-SITE implementation at each site.
Time frame: 24 months
Change in Proportion of Patients Who Complete Annual Diabetic Eye Screening
Comparison of proportion of patients with diabetes adherent with yearly diabetic eye screening guidelines (i.e., "screening rates") between baseline and 12, 36, and up to 48 months following initiation of I-SITE implementation at each site.
Time frame: baseline, 12 months, 36 months, 48 months
Change in follow-up rates for in-person eye care among screen positive patients
Comparison of follow-up rates for in-person eye care among screen positives between baseline and 12, 24, 36, and up to 48 months following initiation of I-SITE implementation at each site.
Time frame: baseline, 12 months, 36 months, 48 months
Identification of workflow strategies, organizational factors, and implementation components that distinguish between health systems with high and low teleophthalmology use
An explanatory mixed methods design including interviews and direct observation as data sources will be used. Qualitative interviews with key clinical informants and direct observation of I-SITE Coach and local implementation team meetings are planned. Configurational Comparative Methods (CCM) will combine qualitative data with quantitative data on teleophthalmology use to characterize differences between health systems. Key clinical informant interviews will be conducted 1 month prior to and 12 months following initiation of I-SITE implementation. Verbatim transcripts of audio recordings from individual interviews will be coded and analyzed using directed content analysis based on the i-PARiHS framework. Qualitative data from fidelity checklists obtained through direct observation of meetings will be coded using a similar analytic approach to that used in the interviews. High and low teleophthalmology use will be defined based on the last 6 months of I-SITE implementation.
Time frame: up to 13 months
Mean Implementation Cost
Implementation costs determined by structured activity logs and project records of all communications between I-SITE Coach, clinical personnel, and research team.
Time frame: up to 48 months
Plan to share: Yes — Data from this study may be requested from other researchers up to 7 years after the completion of the primary outcome by contacting Dr. Yao Liu, the Principal Investigator of this study.
Supporting information: Study protocol, Sap
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University of Wisconsin, Madison