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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241589
Other study ID # SDR 16-192
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 13, 2019
Est. completion date December 31, 2020

Study information

Verified date July 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 466
Est. completion date December 31, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Introduction of Teledermatology Mobile Apps

Intervention

Other:
Direct to patient facing mobile apps introduction
VA employees and Veterans begin use of OCC's direct to patient facing mobile app.

Locations

Country Name City State
United States Durham VA Medical Center, Durham, NC Durham North Carolina
United States Providence VA Medical Center, Providence, RI Providence Rhode Island
United States San Francisco VA Medical Center, San Francisco, CA San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development Durham VA Medical Center, US Department of Veterans Affairs Center for Healthcare Organization & Implementation Research

Country where clinical trial is conducted

United States, 

References & Publications (6)

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 — View 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.

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 — View 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(

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 — View 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.

Outcome

Type Measure Description Time frame Safety issue
Primary Total Number of Participants That Successfully Completed Remote Follow up Whether patient had a successful completion of a remote follow-up visit during the study period, which included 1 year and 4 months. The time frame of the follow up varied as clinically appropriate. 1 year 4 months
Primary Total Number of Participants Who Ever Completed Remote Follow-up Requests Ever completed is defined as those who at first experienced an expired request or no show but eventually completed the request, after subsequent requests were submitted for the same problem. The time frame for the follow-up of each patient was clinically appropriate determined by the dermatologist and thus varied. The collection of whether or not the follow up of patients were ever completed took place over the study period of 1 year and 4 months. 1 year 4 months