I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Cluster-randomized trial with a stepped-wedge initiation of the intervention at each site

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type OTHER

I-SITE

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Implementation for Sustained Impact in Teleophthalmology

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No