Objective(s) and Hypotheses: Diabetic foot ulcers (DFU) are common, debilitating, and
costly complications of diabetes, disproportionately impacting Black and rural Veterans.
Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and
65% within 5 years. Remote temperature monitoring (RTM) of feet is one of the few
interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption
has been poor because the original procedures, including the use of handheld
thermometers, were burdensome and time-consuming. Podimetrics, a private company, has
developed a temperature monitoring system involving a "smart" mat that measure foot
temperatures and a remote monitoring team that works with VA providers to assist with
triage and monitoring. This care model has incredible promise, but has been untested in
VA.
The specific aims of this study are to: 1) Evaluate the effectiveness of RTM vs. usual
care in terms of primary (ulceration) and secondary outcomes (severity of ulceration,
amputation, hospitalization, emergency room visits, quality of life, satisfaction with
care, and self-efficacy for managing diabetes) at 6, 12, 18, and 24 months; 2) Collect
data on costs of RTM and compare with usual care costs, if effectiveness is demonstrated;
and 3) Evaluate the implementation process, including barriers and facilitators to use
among key stakeholders
Research Design: For Aim 1, the investigators will conduct a multi-site randomized
controlled study. Aim 2 involves a budget impact analysis to evaluate costs of RTM. Aim 3
involves qualitative interviews to understand barriers and facilitators to implementation
of RTM.
Methodology: For Aim 1, the investigators will aim to enroll at least 406 patients who
have had a history of DFU or amputation (including active ulcers). Patients will be
randomized 1:1 to RTM or usual care (no RTM), with randomization stratified on site and
active ulcer vs. not. For Aim 2, the investigators will collect data and observe
providers to quantify provider time for selecting patients for RTM, ordering mats, and
responding to alerts of "hot spots". The investigators will use medical records to assess
patient utilization (ulcer/amputation-related outpatient, inpatient, and emergency room
visits) and associated costs of care for patients in the RTM and comparison groups. For
Aim 3, the investigators will conduct semi-structured phone interviews with 30-50
Veterans and 12-30 providers and use the Consolidated Framework for Implementation
Research to guide data collection and analysis.
Relevance to VA Mission: Findings from this study will be used to inform effective,
efficient, and equitable scaling of RTM in VA.
