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

通过智能垫技术进行家庭足部温度监测，以改善高危糖尿病患者的可及性、公平性和结果

• 批准号: 10539209
• 负责人: Alyson Littman
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10539209
• 关键词: Address; Adoption; Affect; Amputation; Behavior; Biometry; Black race; Caregivers; Caring; Case Manager; Complications of Diabetes Mellitus; Consolidated Framework for Implementation Research; Consumption; Contralateral; Cost Analysis; Cost Savings; Data; Data Analyses; Data Collection; Data Sources; Diabetes Mellitus; Diabetic Foot Ulcer; Dissemination and Implementation; Early Diagnosis; Early treatment; Ecosystem; Effectiveness; Emergency department visit; Enrollment; Equity; Exclusion Criteria; Future; Health; Healthcare; Healthcare Systems; Home; Hospitalization; Hot Spot; Improve Access; Individual; Inflammation; Inpatients; Intervention; Interview; Knowledge; Measures; Methodology; Modeling; Monitor; Netherlands; Observational Study; Outcome; Outpatients; Patient Outcomes Assessments; Patient Selection; Patients; Personal Satisfaction; Persons; Play; Privatization; Procedures; Process; Protocols documentation; Provider; Quality of life; Race; Randomized; Randomized, Controlled Trials; Recording of previous events; Recurrence; Reporting; Research; Resources; Risk; Risk Reduction; Role; Rural; Scanning; Seminal; Services; Severities; Site; Skin; Subgroup; System; Technology; Temperature; Thermometers; Time; Triage; Ulcer; Uncertainty; Veterans; Work; budget impact; care costs; cost; data exchange; design; diabetic; effectiveness evaluation; experience; foot; healing; health equity; high risk; implementation barriers; implementation evaluation; implementation facilitators; implementation framework; implementation process; innovation; limb loss; new technology; participant enrollment; primary outcome; programs; public-private partnership; randomized trial; randomized, controlled study; remote assessment; remote monitoring; rurality; satisfaction; secondary outcome; treatment as usual; wireless transmission

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.

背景：糖尿病足溃疡（DFU）是常见的，令人衰弱的糖尿病并发症。那些 溃疡病史有未来溃疡的高风险 - 约40％的患者经历了另一种 溃疡愈合的一年之内，在5年内溃疡65％。 DFU和截肢不成比例地影响 黑人和农村的个人。提出的一个原因是较高的溃疡和截肢率 这些群体是，他们晚些时候在疾病的过程中出现护理，而溃疡更难治疗 保守。确定公平的早期检测和治疗方法可能会有所帮助。高架 几天内维持的温度是炎症的早期迹象，可以有效预测 溃疡。几项随机对照试验表明，每日的足底温度监测使用 手持温度计以及指示患者减少活动的方案，并被A看到 临床，降低了溃疡的风险。然而，收养很差，因为这些程序是燃烧的。 新技术要容易得多，只需要患者将脚放在垫子上20秒钟。 现在可以在患者的家中测量温度数据并进行分析以识别热点。先前的研究 而且我们自己的分析表明，患者按照高规定的指示站在垫子上。 意义：远程温度监测（RTM）的唯一证据降低了溃疡的风险和 截肢来自VA以外进行的一项小型观察性研究（n = 77） 设计。没有随机试验评估了有效性或成本/成本节省的试验 不同的高危退伍军人。此外，没有先前的研究评估了任何患者报告的结果或接受采访 患者或提供者，这对于理解和解决实施障碍和解决方案很重要 传播，如果RTM被证明是有效的。大量的前期费用（每位患者$ 3400 每年）促使一些领导人在VA中要求更严格的数据。 创新和影响：涉及私人公共合作伙伴关系的宽度范围远程生物识别监测 在医疗保健的未来中的主要作用。我们的研究将是第一个评估的大型随机对照试验 RTM嵌入在医疗保健系统中的有效性。这项研究将告知VA如何与私人合作 提高退伍军人健康和福祉的公司。 具体目的：本研究的具体目的是：1）评估RTM与通常护理的有效性 主要（溃疡）和次要结果（溃疡，截肢，住院的严重程度， 在12、18和24个月时，紧急房间探访，生活质量，对护理的满意度以及患者激活）； 2） 如果证明有效性，请收集有关RTM成本的数据，并与通常的护理成本进行比较； 3） 评估实施过程，包括在主要利益相关者中使用的障碍和促进者 实施研究的合并框架指导数据收集和分析。 方法论：为了完成AIM 1，我们将进行3个站点的随机对照研究。患者（n = 406） 在过去的24个月内（包括活跃溃疡）在过去的24个月内有DFU或截肢的人将被随机分配1：1 进行RTM或通常的护理（无RTM），随机化在种族，粗糙度和主动溃疡上与不进行。到 完成目标2，我们将收集数据以进行预算影响分析，以评估RTM的成本， 包括垫子；提供者的时间选择患者，订购垫子以及响应“热火的警报 斑点”；利用（溃疡/截肢相关的门诊，住院和急诊室就诊）。最后， 完成目标3，我们将对利益相关者进行观察和访谈以了解障碍 并协助实施RTM。 下一步：本研究的发现将用于为RTM的有效，高效和公平缩放提供信息 VA。