Direct-to-patient Teledermatology and Computer-assisted D... | NCT05128006

NCT05128006

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
HX003473	Other Grant/Funding Number	VA Office of Research and Development

Status Module

Name	Class
VA Boston Healthcare System	FED
Durham VA Health Care System	FED
Providence VA Medical Center	FED

Oversight Module

Description Module

Detailed 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.

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.
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.
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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
In-person new VA dermatology patients	In-person dermatology patients that are new patients at three facilities
New patient consultative Teledermatology users	New patient consultative Teledermatology users at three facilities
New patient Mobile teledermatology users	New patient Mobile teledermatology users at three facilities	Other: New patient teledermatology visit
In-person new patient in Community Care	In-person new patient in Community Care

Name	Type	Description	Arm Group Labels	Other Names
New patient teledermatology visit	Other	new patient teledermatology visits	New patient Mobile teledermatology users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
New patient in-person dermatology visits	Proportion of in-person dermatology visits that are for new dermatology patients at facility level	4 years
Consult completion time	Total time in days from consult request date to consult completion date, excluding discontinued consults.	4 years
Appointment completion time	Total time in days from appointment create date to appointment completed date following (in-person groups).	4 years
Travel distance for VA care	Average driving distance from the centroid of the patient's residential zip code to physical location of VA dermatology care. Distances for MVAI cases are defined as zero.	4 years
Third next available dermatology clinic appt completion time	Total time in days from appointment create date to third next available clinic appointment date. A forward-looking measure of access. While not as reliable as consult completion time, it is frequently used in VA as a practical forward-looking measure of access.	4 years
New Patient Teledermatology encounters	New TD visits as fraction of total encounters at each facility reflecting degree of TD integration.	4 years
Organizational Readiness to implement mobile teledermatology for direct new patient care

Secondary Outcomes

Measure	Description	Time Frame
Scheduled compared to clinically indicated appointment date	Patient X has a scheduled appointment for x date and clinically indicated date appt was Y so X-Y=Z days. Captures availability in contrast to clinical capacity or clinic booking patterns.	4 years
Whether patient had a no-show event for an intended encounter

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Dennis H Oh, MD PhD	Contact	(415) 750-2091		Dennis.Oh@va.gov
Sara B Peracca, PhD MPH MS	Contact	(415) 221-4810	23797	sara.peracca@va.gov

Name	Affiliation	Role
Dennis H. Oh, MD PhD	San Francisco VA Medical Center, San Francisco, CA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco VA Medical Center, San Francisco, CA	Recruiting	San Francisco	California	94121-1563	United States

IPD Sharing Statement Module

Using the Organizational Readiness for Implementing Change survey the investigators will attain an overall average score by facility and a score for the 3 facilities in the study combined to indicate organizational readiness to implement a new patient mobile teledermatology. The score is derived from a Likert response scale from 1 to 5. Higher score denotes higher organizational readiness.