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Implementation of Teleophthalmology in Urban Health Systems Study

Primary Purpose

Diabetic Retinopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-SITE Intervention
Usual Care Teleophthalmology
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Retinopathy focused on measuring screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eligible medical records will be identified using ICD-10 codes for diabetes type 1 or type 2 Billing data will be identified using teleophthalmology (CPT codes 92228 or 92250) Identification of eligible records will be performed by clinic personnel at each health system who already have full access to their patient data as part of their employment, and regularly gather and report this type of data to health insurers as part of their clinical role Exclusion Criteria: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Usual Care Followed by I-SITE Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Diabetic Screening Rate
    Proportion of patients with diabetes with medical record documentation of diabetic eye screening within the last 12 months among patients with type 1 or type 2 diabetes who had at least 2 clinic visits with primary care provider within the past 24 months.

    Secondary Outcome Measures

    Monthly Teleophthalmology Use
    Monthly number of patients for whom an eye photo was ordered and for whom an eye photo was completed
    Follow Up Rate For In-Person Eye Care Among Screen Positives
    Comparison of follow-up rates for in-person eye care among patients who have screened positive for ocular pathology requiring further in-person eye care on their teleophthalmology photos and subsequently obtained an in-person dilated eye exam with an eye care provider within 1 year of their teleophthalmology visit based on medical records review.

    Full Information

    First Posted
    March 2, 2023
    Last Updated
    March 16, 2023
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Eye Institute (NEI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05773495
    Brief Title
    Implementation of Teleophthalmology in Urban Health Systems Study
    Official Title
    Implementation of Teleophthalmology in Urban Health Systems Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    August 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Eye Institute (NEI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study 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 urban, multi-payer health systems.
    Detailed Description
    The goal is to adapt I-SITE to a new population by identifying and testing strategies to overcome key barriers to teleophthalmology use among Latinos and Black Americans with diabetes. The investigators will develop and test a culturally-adapted I-SITE intervention in urban, federally-qualified health centers serving low-income, Black and Latinx communities. The primary hypothesis is that the intervention will significantly increase the diabetic eye screening rate (primary outcome) at Access CHC and Outreach CHC at 6- and 12-months post-implementation compared to baseline. Secondary outcomes include monthly teleophthalmology use and follow-up rates for in-person eye care among screen positives. These data will facilitate rapid dissemination by helping key decision makers, such as health system administrators, determine whether to adopt the culturally-adapted I-SITE intervention. The investigators are using a pre-post study design at each health system (site) to compare: (1) usual care teleophthalmology vs. the (2) I-SITE intervention. Usual Care Teleophthalmology: All sites will initially receive usual care teleophthalmology, consisting of having an active teleophthalmology program located in the primary care clinic and access to the I-SITE online toolkit. The I-SITE online toolkit has been freely-available since December 2019 to all U.S. health systems and the general public. Health systems may also contact the study team for assistance with technical issues. All sites will utilize non-mydriatic retinal cameras (e.g. Topcon NW400) located in their primary care clinic to obtain a single 45-degree photo of the disc and macula with an anterior photo in each eye to provide diabetic eye screening as part of patients' usual care. Images are captured by trained primary care personnel and securely transmitted to eye doctors for evaluation. This workflow is based on existing protocols and guidelines set by the American Telemedicine Association Practice Recommendations for Diabetic Retinopathy. I-SITE Intervention: Each site will subsequently receive all elements of usual care teleophthalmology plus the I-SITE implementation program. I-SITE is a coaching facilitated implementation program that guides clinical personnel through tailored integration of teleophthalmology into primary care workflows. The I-SITE intervention includes: Initial 30-minute live webinar introduction and question & answer session between the I-SITE Coach and the participating primary care clinics. Two in-person 1-hour meetings between the I-SITE Coach and the local clinic team to discuss the teleophthalmology workflow, review current teleophthalmology use, diabetic eye screening rates, follow-up rates for in-person eye care among screen positives, set goals, and select implementation strategies to test. The meetings are to occur within 6 weeks after the introductory webinar. A series of 10 monthly teleconferences (15-30 min.) following the in-person meetings where the I-SITE Coach and local clinic team test and refine implementation strategies by reviewing data and providing feedback. Two I-SITE Coaches will be present at all meetings (i.e., lead and assistant coach) to ensure continuity in case the lead I-SITE Coach is unexpectedly unable to attend a meeting. I-SITE Coaches will also perform a half-day, on-site visit to physically walkthrough the teleophthalmology workflow, as well as meet with clinic administrators and staff, on the date of the first in-person meeting. Data Collection Procedures: Patient data will be collected within the established electronic health record at each participating health system as part of routine patient care, de-identified, and exported for secondary data analysis by clinic personnel at each health system who already have full access to their patient data as part of their employment, and regularly gather and report this type of data to health insurers as part of their clinical role (e.g., clinical quality improvement and electronic health record/information technology staff ). Personnel from each participating health system will only have access to data from their own health system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Retinopathy
    Keywords
    screening

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care Followed by I-SITE Intervention
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    I-SITE Intervention
    Intervention Description
    I-SITE is a coaching facilitated implementation program that guides clinical personnel through tailored integration of teleophthalmology into primary care workflows.
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care Teleophthalmology
    Intervention Description
    All sites will initially receive usual care teleophthalmology, consisting of having an active teleophthalmology program located in the primary care clinic and access to the I-SITE online toolkit. All sites will utilize non-mydriatic retinal cameras (e.g. Topcon NW400) located in their primary care clinic to obtain a single 45-degree photo of the disc and macula with an anterior photo in each eye to provide diabetic eye screening as part of patients' usual care. Images are captured by trained primary care personnel and securely transmitted to eye doctors for evaluation.
    Primary Outcome Measure Information:
    Title
    Change in Diabetic Screening Rate
    Description
    Proportion of patients with diabetes with medical record documentation of diabetic eye screening within the last 12 months among patients with type 1 or type 2 diabetes who had at least 2 clinic visits with primary care provider within the past 24 months.
    Time Frame
    baseline (data is retrospective to evaluate pre-intervention beginning November 2022), 6 months post-intervention (up to 18 months), 12 months post-intervention (up to 24 months)
    Secondary Outcome Measure Information:
    Title
    Monthly Teleophthalmology Use
    Description
    Monthly number of patients for whom an eye photo was ordered and for whom an eye photo was completed
    Time Frame
    data collected monthly (retrospectively beginning November 2022 and up to 36 months prospectively)
    Title
    Follow Up Rate For In-Person Eye Care Among Screen Positives
    Description
    Comparison of follow-up rates for in-person eye care among patients who have screened positive for ocular pathology requiring further in-person eye care on their teleophthalmology photos and subsequently obtained an in-person dilated eye exam with an eye care provider within 1 year of their teleophthalmology visit based on medical records review.
    Time Frame
    baseline (data is retrospective to evaluate pre-intervention beginning November 2022) and 12, 24, and 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eligible medical records will be identified using ICD-10 codes for diabetes type 1 or type 2 Billing data will be identified using teleophthalmology (CPT codes 92228 or 92250) Identification of eligible records will be performed by clinic personnel at each health system who already have full access to their patient data as part of their employment, and regularly gather and report this type of data to health insurers as part of their clinical role Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Loren Lock, MS
    Phone
    608-265-6635
    Email
    llock@wisc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yao Liu, MD, MS
    Phone
    608-263-1481
    Email
    yao.liu2@wisc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yao Liu, MD, MS
    Organizational Affiliation
    UW School of Medicine and Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data regarding patient demographics, whether they obtained diabetic eye screening, had teleophthalmology performed, any vision-threatening eye condition identified by teleophthalmology, and whether they followed-up for in-person eye care if they screened positive will be available to share.
    IPD Sharing Time Frame
    up to 7 years after the completion of the primary outcome
    IPD Sharing Access Criteria
    contact study PI for access
    Links:
    URL
    https://www.hipxchange.org/I-SITE
    Description
    A Guide to Implementation for Sustained Impact in Teleophthalmology (I-SITE)

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