I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
5 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedStudy Start
First participant enrolled
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 15, 2026
May 1, 2026
4.4 years
February 23, 2022
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (4)
Change in Proportion of Patients Who Complete Annual Diabetic Eye Screening
baseline, 12 months, 36 months, 48 months
Change in follow-up rates for in-person eye care among screen positive patients
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
up to 13 months
Mean Implementation Cost
up to 48 months
Study Arms (1)
Intervention
OTHERUp 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Eye Institute (NEI)collaborator
Study Sites (1)
UW School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
Related Publications (2)
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: 33216697BACKGROUNDTorres 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: 34229748BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yao Liu, MD, MS
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
February 24, 2022
Study Start
March 28, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- up to 7 years after the completion of the primary outcome
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.