I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: I-SITE.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Proportion of Patients Who Complete Annual Diabetic Eye Screening [Time frame: 24 months]
Secondary outcome measures (4)
- Change in Proportion of Patients Who Complete Annual Diabetic Eye Screening [Time frame: baseline, 12 months, 36 months, 48 months]
- Change in follow-up rates for in-person eye care among screen positive patients [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 [Time frame: up to 13 months]
- Mean Implementation Cost [Time frame: up to 48 months]
Eligibility criteria
Inclusion criteria
- Health system serves rural patients as defined as those patients living in counties considered rural by the federal Office of Management and Budget (OMB)
- Health system has an active clinical teleophthalmology program providing diabetic eye screening in primary care prior to study randomization
- Health system agrees to share de-identified patient data at the requested time intervals
Exclusion criteria
- Health system does not serve a rural patient population
- Health system has a diabetic eye screening rate of greater than 50% (e.g., above the national average) as it may limit the ability to measure improvement from I-SITE
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- UW School of Medicine and Public Health — Madison
Publications
- Liu Y, Carlson JN, Torres Diaz A, Lock LJ, Zupan NJ, Molfenter TD, Mahoney JE, Palta M, Boss D, Bjelland TD, Smith MA. Sustaining Gains in Diabetic Eye Screening: Outcomes from a Stakeholder-Based Implementation Program for Teleophthalmology in Primary Care. Telemed J E Health. 2021 Sep;27(9):1021-1028. doi: 10.1089/tmj.2020.0270. Epub 2020 Nov 19. PMID 33216697
- Torres Diaz A, Lock LJ, Molfenter TD, Mahoney JE, Boss D, Bjelland TD, Liu Y. Implementation for Sustained Impact in Teleophthalmology (I-SITE): applying the NIATx Model for tailored implementation of diabetic retinopathy screening in primary care. Implement Sci Commun. 2021 Jul 6;2(1):74. doi: 10.1186/s43058-021-00175-0. PMID 34229748
Identifiers
NCT: NCT05254535 · 2021-1474 · UG1EY032446 · Protocol Version 1/25/2022 · A536000 · 2022-0121