Abstract

Background: Diabetic foot ulcers (DFU) are common, debilitating, and costly complications of diabetes. Those with a history of ulceration are at high risk of future ulcerations -- about 40% of patients experience another ulcer within a year of ulcer healing and 65% within 5 years. DFU and amputation disproportionately impact individuals who are Black and rural. One proposed reason for the higher ulceration and amputation rates in these groups is that they present for care later in the course of illness with ulcers that are more difficult to treat conservatively. Identifying equitable approaches to early detection and treatment could help. Elevated temperatures that are sustained over several days are an early sign of inflammation and can effectively predict ulceration. Several randomized controlled trials demonstrated that daily plantar temperature monitoring using handheld thermometers along with a protocol that instructed patients to reduce activity and be seen by a clinician, reduced the risk of ulceration. Yet adoption was poor because the procedures were burdensome. New technologies are much easier, and only require patients to place their feet on a mat for 20 seconds. Temperature data can now be measured in the patient’s home and analyzed to identify hot spots. A prior study and our own analyses have demonstrated that patients stand on the mat as directed with high compliance. Significance: The only evidence that remote temperature monitoring (RTM) reduces the risk of ulceration and amputation comes from a small observational study (n=77) conducted outside the VA, that used a pre-post design. There have been no randomized trials that have evaluated effectiveness or costs/cost-savings for different at-risk Veterans. Also, no prior studies have evaluated any patient-reported outcomes, or interviewed patients or providers, which will be important to understand and address barriers to implementation and dissemination, should RTM be demonstrated to be effective. The substantial upfront cost ($3400 per patient per year) has prompted some leaders to call for more rigorous data in VA. Innovation and Impact: Widescale remote biometric monitoring involving private-public partnerships will play a major role in the future of healthcare. Our study will be the first large, randomized controlled trial to evaluate effectiveness of RTM embedded in a healthcare system. This study will inform how VA can work with private companies to enhance the health and well-being of Veterans. Specific Aims: 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 patient activation) at 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 using the Consolidated Framework for Implementation Research to guide data collection and analysis. Methodology: To accomplish Aim 1, we will conduct a 3-site randomized controlled study. Patients (n=406) who have had a DFU or amputation within the past 24 months (including active ulcers) will be randomized 1:1 to RTM or usual care (no RTM), with randomization stratified on race, rurality, and active ulcer vs. not. To accomplish Aim 2, we will collect data to conduct a budget impact analysis that will evaluate costs of RTM, which include the mats; provider time for selecting patients, ordering mats, and responding to alerts of “hot spots”; and utilization (ulcer/amputation-related outpatient, inpatient, and emergency room visits). Finally, to accomplish Aim 3, we will conduct observations of, and interviews with stakeholders to understand barriers and facilitators to implementation of RTM. Next steps: Findings from this study will be used to inform effective, efficient, and equitable scaling of RTM in VA.

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DRA: Diabetes and Other Endocrine Disorders

DRE: TRL - Applied/Translational, Treatment - Comparative Effectiveness

Keywords: Comparative Effectiveness, Diabetes, Quality of Care, Rural, Symptom Management

MeSH Terms: None at this time.