Home foot-temperature monitoring through smart mat technology to improve access, equity, and outcomes in high-risk patients with diabetes

背景：糖尿病足溃疡（DFU）是糖尿病常见的、使人衰弱的和昂贵的并发症。那些 有溃疡病史的患者未来溃疡的风险很高--大约40%的患者会经历另一次溃疡。 溃疡在一年内愈合，65%在5年内愈合。DFU和截肢不成比例地影响 黑人和农村人。一个提出的原因是溃疡和截肢率较高， 这些群体的问题是，他们在疾病过程中后期出现更难治疗的溃疡 保守地说确定早期发现和治疗的公平方法可能有所帮助。升高 持续数天的温度是炎症的早期迹象，可以有效地预测 溃疡几项随机对照试验表明，每日足底温度监测使用 手持温度计沿着，并指导患者减少活动， 临床医生，降低溃疡的风险。然而，由于程序繁琐，收养情况很差。 新技术更容易，只需要患者将脚放在垫子上20秒。 现在可以在患者家中测量温度数据并进行分析以识别热点。既往研究 并且我们自己的分析已经证明，患者按照指示站在垫子上具有高顺应性。 意义：远程温度监测（RTM）降低溃疡风险的唯一证据， 截肢来自于在VA之外进行的一项小型观察性研究（n=77），该研究使用了术前和术后 设计目前还没有随机试验评估以下方面的有效性或成本/成本节约： 不同的高危退伍军人此外，没有先前的研究评估任何患者报告的结果，或采访 患者或提供者，这对于理解和解决实施障碍非常重要， 传播，应证明RTM是有效的。大量的前期费用（每位患者3400美元 每年）促使一些领导人呼吁在弗吉尼亚州提供更严格的数据。 创新和影响：涉及公私合作伙伴关系的大规模远程生物识别监测将发挥作用 在未来的医疗保健中扮演重要角色。我们的研究将是第一个大型的随机对照试验，以评估 RTM嵌入在医疗保健系统中的有效性。这项研究将告知VA如何与私人 公司，以提高退伍军人的健康和福祉。 具体目的：本研究的具体目的是：1）评价RTM与常规护理在以下方面的有效性： 主要结果（溃疡）和次要结果（溃疡的严重程度，截肢，住院， 12、18和24个月时的急诊室访视、生活质量、护理满意度和患者激活）; 2） 收集关于RTM成本的数据，并与常规护理成本进行比较（如果证明有效）;以及3） 评估实施过程，包括关键利益相关者使用的障碍和促进因素， 实施研究综合框架，以指导数据收集和分析。 方法：为了实现目标1，我们将进行一项3中心随机对照研究。患者（n=406） 在过去24个月内发生过DFU或截肢（包括活动性溃疡）的患者将按1：1的比例随机分配 接受RTM或常规治疗（无RTM），随机化按种族、农村和活动性溃疡分层。到 为了实现目标2，我们将收集数据，进行预算影响分析，以评估RTM的成本， 其中包括垫子;提供选择患者、订购垫子和响应“热”警报的时间 和利用率（溃疡/截肢相关门诊、住院和急诊室就诊）。最后为 为了实现目标3，我们将对利益相关者进行观察和访谈，以了解障碍 以及RTM实施的促进者。 下一步：本研究的结果将用于为RTM的有效，高效和公平扩展提供信息， 弗吉尼亚

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.