Direct-to-patient Teledermatology and Computer-assisted Diagnosis

Last updated: February 28, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

New patient teledermatology visit

Clinical Study ID

NCT05128006
IIR 21-103
HX003473
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will examine access to dermatology care. The operational partner will implement a direct-to-new patient teledermatology clinical care pathway while the research will study the effects of that implementation, use data associated with deployment to develop and test an Artificial Intelligence system, and understand key stakeholders' attitudes regarding and readiness for remote dermatology care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New patient referrals to dermatology at San Francisco, Decatur, and Aurora from 2021-2025

Exclusion

Exclusion Criteria:

  • Patients who are not dermatology patients

  • Dermatology patients who are not seen at San Francisco, Decatur, and Aurora

  • Dermatology patients at San Francisco, Decatur, and Aurora who have visits onlybefore 2021 or after 2025

Study Design

Total Participants: 63200
Treatment Group(s): 1
Primary Treatment: New patient teledermatology visit
Phase:
Study Start date:
November 07, 2022
Estimated Completion Date:
September 30, 2026

Study Description

VA is uniquely positioned to develop and study direct-to-patient teledermatology in parallel with computer vision for skin disease. The following aims will assess the performance of these emerging patient-facing dermatology innovations and assess their ability to improve access to quality skin care VA-wide.

  1. Assess the impact of direct-to-patient teledermatology on access and health system utilization. In collaboration with the VA operational partner, Office of Connected Care, the My VA Images app will be deployed to three VA facilities where the app will be introduced as an option to refer eligible new patients for dermatology consultation. Multiple access metrics, including time to consult completion and geographic distance traveled. will be measured in exposed patients and compared with patients referred to usual in-person and consultative teledermatology pathways. Facility-centric measures of access such as clinic appointment wait times and in-person dermatology clinic and community care utilization will also be measured. To better understand end-user experiences, the investigators will survey patients and staff at each study site to evaluate their satisfaction with My VA Images as well as the overall process.

  2. Assess, refine and augment computer-assisted evaluation of patient-submitted images. An artificial intelligence-powered computer vision model, trained and validated on clinic-captured images of melanoma and nevi, will be tested and refined on patient-submitted teledermatology images from the My VA images app. The investigators will also extend the computer vision model by using all patient submissions to train and validate the model on a wider variety of skin diagnoses. Patient-submitted teledermatology images at study sites will be prospectively evaluated by the investigators' own computer vision model as well as by a commercial system currently available to VA clinicians and patients, and results will be compared with benchmark diagnoses to measure concordance across a range of diagnostic categories.

  3. Assess readiness of VA and Veterans' acceptance to implement direct-to-patient care. The investigators will survey Veterans and key VA leadership and staff at three selected VA facilities, supplemented by interviews of key VA stakeholders, to understand patients' and organizational readiness, including facilitators and barriers, for transitioning to patient-facing technologies in general, and direct-to-patient dermatologic care in particular. National Veteran surveys, and VA Mobile Health user satisfaction data will help place local observations in perspective. Implementation and sustainability of the patient-facing teledermatology app technology will also be measured.

Connect with a study center

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California 94121-1563
    United States

    Active - Recruiting

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado 80045-7211
    United States

    Site Not Available

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia 30033-4004
    United States

    Site Not Available

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