Randomized Controlled Trial of Remote Foot Temperature Monitoring
Study Details
Study Description
Brief Summary
Diabetic foot ulcers 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. Monitoring plantar foot temperatures 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 can wirelessly transmit data 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 investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 patient activation) 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 3-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 DFU or amputation within the past 24 months (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 6-12 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remote temperature monitoring + enhanced usual care Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below) |
Other: Remote foot temperature monitoring system
Remote temperature monitoring involves a thermometric mat that can detect "hot spots" on the plantar surface of the foot. The mat has embedded cellular connectivity so that data can be transmitted from the patient's home to the company, where the temperature data can be analyzed. The company has a team of health coaches that work with patients and providers to detect signs of damage early in order to prevent ulceration.
Other: Enhanced usual care
Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation.
Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and whole health opportunities
|
| Other: Enhanced usual care Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation. Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and Whole Health opportunities |
Other: Enhanced usual care
Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation.
Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and whole health opportunities
|
Outcome Measures
Primary Outcome Measures
- Foot ulceration [24 months]
The primary outcome is the presence of new ulceration through 24 months
Secondary Outcome Measures
- Lower limb amputation [24 months]
Any level of lower extremity amputation
- Quality of life [6,12, 18 and 24 months]
PROMIS Global Health 1.2
- Satisfaction with care [6,12, 18 and 24 months]
Short assessment of patient satisfaction (SAPS) Hawthorne G et al
- Patient activation [6, 12, 18, and 24 months]
10-item Patient activation measure by Skolasky et al
Other Outcome Measures
- Utilization (outpatient visits, emergency room visits, hospitalizations) [6, 12, 18, and 24 months]
Based on electronic medical record data
Eligibility Criteria
Criteria
Inclusion Criteria:
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Veteran
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Diabetes diagnosis
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Presence of foot ulcer up to 24 months prior (including active ulcer)
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Lower extremity amputation up to 24 months prior (including unhealed amputation)
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Able to understand/read English
Exclusion Criteria:
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Dementia
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Unable to ambulate
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Bilateral lower extremity amputation
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Ankle brachial index <0.6
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Life expectancy less than 18 months
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Currently using in-home temperature monitoring
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Prisoner
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | United States | 60141-3030 |
| 2 | Hunter Holmes McGuire VA Medical Center, Richmond, VA | Richmond | Virginia | United States | 23249 |
| 3 | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | United States | 98108-1532 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Alyson J. Littman, PhD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 21-176