Diabetic RetinopathyNCT05254535
I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
A study testing I-SITE in people with Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- I-SITE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
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.
Read the 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.
- Conditions
- Diabetic Retinopathy
- Being tested
- I-SITE
- Keywords
- Rural Health, Screening, Teleophthalmology, Telemedicine, Preventative Medicine
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-SITEOther
Also called Implementation for Sustained Impact in Teleophthalmology
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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. Receives: Other: I-SITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
Change in 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 12, 36, and up to 48 months following initiation of I-SITE implementation at each site.
Measured: baseline, 12 months, 36 months, 48 months
Change in follow-up rates for in-person eye care among screen positive patients
Comparison of follow-up rates for in-person eye care among screen positives between baseline and 12, 24, 36, and up to 48 months following initiation of I-SITE implementation at each site.
Measured: 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
An explanatory mixed methods design including interviews and direct observation as data sources will be used. Qualitative interviews with key clinical informants and direct observation of I-SITE Coach and local implementation team meetings are planned. Configurational Comparative Methods (CCM) will combine qualitative data with quantitative data on teleophthalmology use to characterize differences between health systems.
Key clinical informant interviews will be conducted 1 month prior to and 12 months following initiation of I-SITE implementation. Verbatim transcripts of audio recordings from individual interviews will be coded and analyzed using directed content analysis based on the i-PARiHS framework.
Qualitative data from fidelity checklists obtained through direct observation of meetings will be coded using a similar analytic approach to that used in the interviews.
High and low teleophthalmology use will be defined based on the last 6 months of I-SITE implementation.
Measured: up to 13 months
Mean Implementation Cost
Implementation costs determined by structured activity logs and project records of all communications between I-SITE Coach, clinical personnel, and research team.
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start28 Mar 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster-randomized trial with a stepped-wedge initiation of the intervention at each site
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Yao Liu, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254535
- Sponsor's protocol ID
- 2021-1474
- Other IDs
- UG1EY032446, Protocol Version 1/25/2022, A536000, 2022-0121
- Status last verified
- May 2026
- First submitted
- 23 Feb 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 33216697Torres 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.
PubMed 34229748
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
- ClinicalTrials.gov ID
- NCT05254535
- Acronym / sponsor ID
- 2021-1474
- Conditions
- Diabetic Retinopathy
- Keywords
- Rural Health, Screening, Teleophthalmology, Telemedicine, Preventative Medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cluster-randomized trial with a stepped-wedge initiation of the intervention at each site
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: I-SITEUp 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-SITEAlso: Implementation for Sustained Impact in TeleophthalmologyI-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. | Other | Intervention |
Primary outcome
Proportion of Patients Who Complete Annual Diabetic Eye Screening
Time frame: 24 months
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 33216697Liu 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.
- Background: PubMed 34229748Torres 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.
- I-SITE free online toolkitLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yao Liu, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-SITE in people with Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Complete Annual Diabetic Eye Screening (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.