Clinical trial NCT03241589: Teledermatology Mobile App: Patient Facing
Official title: Teledermatology Mobile Apps: Implementation and Impact on Veterans' Access to Dermatology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Introduction of Teledermatology Mobile Apps
Keywords: Teledermatology
Telehealth
Dermatology
Telemedicine
Mobile Application
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
name: Durham VA Medical Center
First posted: 2017-08-07
Enrollment: 466
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at sites in study who received consultative teledermatology requests via My VA Images.

Brief summary: This study was designed to measure the impact of two teledermatology apps to provide direct to patient teledermatology follow up care, Patient Viewer and My VA Images, with a trial on access to dermatology care. The overall hypothesis was that sites implementing Department of Veterans Affairs' (VA) teledermatology mobile apps would significantly augment the use of teledermatology and improve Veterans' access to skin care relative to control sites. Specifically, the investigators hypothesized that these apps would improve established patients' ability to follow-up with dermatology care remotely, reducing patient travel to dermatology clinics while opening up dermatology clinic space for other patients. Due to a lack of participation by sites during the study which was conducted during the novel coronavirus (COVID-19) pandemic, the groups examined are Veterans who live in rural areas compared to those in urban areas.

Previously the study included a parallel trial to evaluate another teledermatology mobile app, VA Telederm. This trial was no longer feasible within this study's funding timeline due to limitations imposed on the mobile app by Office of Information \& Technology that were not under the control of the PI or the operational partner, Office of Connected Care (OCC).

Detailed description: Access to healthcare is a key priority for the Department of Veterans Affairs (VA). The current practice of teledermatology in VA is effective but has not been uniformly implemented. Once patients establish care in a dermatology clinic, they often need follow-up visits to evaluate responses to treatment and to adjust management, neither of which necessarily requires a face-to-face visit. To improve clinic access to in-person dermatology clinics, VA Office of Connected Care developed a patient-facing mobile app, My VA Images, to be used in conjunction with the clinician-facing Patient Viewer app, to allow established dermatology clinic patients to follow-up remotely by submitting digital skin images and interval history. The mobile apps were planned for wide-spread implementation in the VA. The investigators conducted a trial of database review to understand how these two apps affected features of dermatology care, specifically related to access to care.

The apps were made available over a 1 year and 4 month period in a cluster randomized, stepped-wedge design to Veterans Health Administration (VHA) facilities. The direct-to-patient facing apps were distributed to 31 facilities with dermatology clinics that had recent relatively high teledermatology activity and thus already had relatively mature teledermatology programs ready for advanced operations.

By using a stop code unique to this process, the investigators planned to use the VA Corporate Data Warehouse (CDW) to measure effectiveness of the apps on all outcomes reflecting dermatology access. Due to an unexpectedly small sample size resulting from poor adoption of the intervention, in part during the COVID-19 pandemic, analysis using the cluster-randomized stepped wedge design evaluation was not warranted. Instead, we focused on understanding factors associated with successful completion of consults with the mobile apps, examining differences between rural and urban Veteran users. The results are of significance to VA as it develops and implements other mobile telehealth programs, and more generally to other healthcare organizations planning for large-scale telehealth interventions.

The planned study originally also included a parallel trial to evaluate another teledermatology mobile app, VA Telederm, designed to facilitate adoption of consultative teledermatology and enhance overall access to dermatology opinion in VA. Unforeseen changes in the app hosting environment imposed by VA Office of Information and Technology early in the study and not under the control of the PI or the operational partner, Office of Connected Care (OCC), rendered the app non-functional, and the trial was no longer feasible within this study's funding timeline were not under the control of the PI or the operational partner, Office of Connected Care (OCC). Organizational readiness for change for the VA Telederm app was measured.

Eligibility criteria: Inclusion Criteria:

* The inclusion criterion for the trial with direct to patient facing apps was that a site had greater than or equal to 9% of all Fiscal Year (FY) 2018 dermatology encounters under secondary stop codes 695/696.
* This indicated considerable pre-existing experience with consultative teledermatology and the likely presence of dermatology reader and support personnel needed to implement direct to patient facing apps.
* The investigators identified 31 sites eligible for direct to patient facing apps.
* We followed above criteria but due to low enrollment, an additional criteria was added that patients were included if they received a request to use the patient-facing mobile app.

Exclusion Criteria:

* VA medical centers with no 695/696 stop code activity in FY2018 or with zero full-time equivalent dermatologists were excluded since these sites likely lacked the expertise, support, and infrastructure to feasibly adopt teledermatology during the study period.
* The investigators also excluded sites outside the continental U.S., and sites without a dermatology clinic.

Primary outcomes:
measure: Total Number of Participants That Successfully Completed Remote Follow up
timeFrame: 1 year 4 months
measure: Total Number of Participants Who Ever Completed Remote Follow-up Requests
timeFrame: 1 year 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Dennis H. Oh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peracca SB, Jackson GL, Jackson MA, Oh DH. Implementation of Teledermatology: Theory and Practice. Current Dermatology Reports. 2019 Jun 1; 8(2):35-45.
citation: Done N, Oh DH, Weinstock MA, Whited JD, Jackson GL, King HA, Peracca SB, Elwy AR, Prentice JC. VA Telederm study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process. BMJ Open. 2018 Dec 14;8(12):e022218. doi: 10.1136/bmjopen-2018-022218.
citation: Fonseca A, Peracca SB, Lachica O, Morris I, King H, Jackson G, Whited J, Oh DH, Weinstock MA. 379 Implementing a teledermatology patient-facing mobile application in the VA. [Abstract]. The Journal of Investigative Dermatology. 2020 Jul 1; 140(7):S48.
citation: Peracca S, Fonseca A, Grenga A, Jackson G, King H, Chapman J, Whited J, Weinstock M, Oh DH. 411 Implementation of a consultative teledermatology mobile application in Veterans Affairs. [Abstract]. The Journal of Investigative Dermatology. 2020 Jul 1; 140(7):S53.
citation: Peracca SB, Fonseca A, Hines A, King HA, Grenga AM, Jackson GL, Whited JD, Chapman JG, Lamkin R, Mohr DC, Gifford A, Weinstock MA, Oh DH. Implementation of Mobile Teledermatology: Challenges and Opportunities. Telemed J E Health. 2021 Dec;27(12):1416-1422. doi: 10.1089/tmj.2020.0500. Epub 2021 Mar 1.
citation: Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.
citation: Peracca SB, Fonseca AS, Lachica O, Jackson GL, Morris IJ, King HA, Misitzis A, Whited JD, Mohr DC, Lamkin RP, Gifford AL, Weinstock MA, Oh DH. Organizational Readiness for Patient-Facing Mobile Teledermatology to Care for Established Veteran Patients in the United States. Telemed J E Health. 2023 Jan;29(1):72-80. doi: 10.1089/tmj.2022.0009. Epub 2022 May 24.