NCT03241589

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 26, 2017

Results QC Date

October 14, 2021

Last Update Submit

July 19, 2023

Conditions

Keywords

TeledermatologyTelehealthDermatologyTelemedicineMobile Application

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Rural Veterans

Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas receiving a request to use the patient facing app.

Other: Direct to patient facing mobile apps introduction

Nonrural Veterans

Originally the comparison group consisted of VA sites to eventually receive the direct to patient facing apps. Since our enrollment at the facility level was low, this arm now consists of Veterans receiving a request to use the patient facing app, living in nonrural areas.

Other: Direct to patient facing mobile apps introduction

Interventions

VA employees and Veterans begin use of OCC's direct to patient facing mobile app.

Nonrural VeteransRural Veterans

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients at sites in study who received consultative teledermatology requests via My VA Images.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Related Publications (8)

  • Peracca SB, Jackson GL, Jackson MA, Oh DH. Implementation of Teledermatology: Theory and Practice. Current Dermatology Reports. 2019 Jun 1; 8(2):35-45.

    BACKGROUND
  • 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.

  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

  • 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.

  • Peracca SB, Lachica O, Lamkin RP, Jackson GL, Mohr DC, King HA, Whited JD, Fonseca AS, Morris IJ, Gifford AL, Weinstock MA, Oh DH. Implementation of Direct-to-Patient Mobile Teledermatology in VA. J Gen Intern Med. 2024 Feb;39(Suppl 1):97-105. doi: 10.1007/s11606-023-08480-1. Epub 2024 Jan 22.

  • 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.

Limitations and Caveats

Due to an unexpectedly small sample size resulting from poor adoption of the intervention by sites during the study, which was in part conducted during the novel coronavirus (COVID-19) pandemic, we were not able to follow the original cluster-randomized stepped wedge analysis plan.

Results Point of Contact

Title
Sara Peracca
Organization
VHA

Study Officials

  • Dennis H. Oh, MD PhD

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 7, 2017

Study Start

May 13, 2019

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

July 27, 2023

Results First Posted

February 18, 2022

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations