跳至主要内容
临床试验/NCT03241589
NCT03241589已完成不适用

Teledermatology Mobile Apps: Implementation and Impact on Veterans' Access to Dermatology

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 466 人开始时间: 2019年5月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
466
试验地点
6
主要终点
Total Number of Participants Who Ever Completed Remote Follow-up Requests

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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/
  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Direct to patient facing mobile apps introduction (Other)

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.

干预措施: Direct to patient facing mobile apps introduction (Other)

结局指标

主要结局

Total Number of Participants Who Ever Completed Remote Follow-up Requests

时间窗: 1 year 4 months

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.

Total Number of Participants That Successfully Completed Remote Follow up

时间窗: 1 year 4 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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