Clinical trial NCT05254535: I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
Official title: I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Rural Health
Screening
Teleophthalmology
Telemedicine
Preventative Medicine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2022-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster-randomized trial with a stepped-wedge initiation of the intervention at each site
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Proportion of Patients Who Complete Annual Diabetic Eye Screening
timeFrame: 24 months
Secondary outcomes:
measure: Change in Proportion of Patients Who Complete Annual Diabetic Eye Screening
timeFrame: baseline, 12 months, 36 months, 48 months
measure: Change in follow-up rates for in-person eye care among screen positive patients
timeFrame: baseline, 12 months, 36 months, 48 months
measure: Identification of workflow strategies, organizational factors, and implementation components that distinguish between health systems with high and low teleophthalmology use
timeFrame: up to 13 months
measure: Mean Implementation Cost
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Yao Liu, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.