Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT05254535
Brief Summary:
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.
Detailed Description:
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:
* Teleophthalmology in primary care clinic
* I-SITE online toolkit
* Technical assistance from study team via email
* Introductory live webinar with question \& answer session (30 min) between I-SITE Coach and primary care clinic
* Series of 2 in-person meetings over 6 weeks (45-60 min.) between I-SITE Coach and local implementation team
* Series of 10 monthly teleconferences (15-30 min.) between I-SITE Coach and local implementation team
* Series of 4 quarterly group teleconferences (45-60 min.) between I-SITE Coach and local implementation teams
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.
Study:
NCT05254535
Study Brief:
Protocol Section:
NCT05254535