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)是一种常见的、使人虚弱的、昂贵的糖尿病并发症。那些 有溃疡病史的人未来溃疡的风险很高--约40%的患者经历过另一次 溃疡愈合一年内占65%，5年内占65%。DFU和截肢的影响不成比例 黑人和农村人。溃疡和截肢率较高的一个拟议原因是 这些群体的特点是，他们在病程较晚的时候出现溃疡，而溃疡更难治疗。 保守地说。确定早期发现和治疗的公平方法可能会有所帮助。高架 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 手持式体温计，以及指示患者减少活动并由 临床医生，降低了溃疡的风险。然而，领养情况很差，因为程序繁琐。 新技术要容易得多，只需要患者将脚放在垫子上20秒。 体温数据现在可以在患者家中测量并进行分析，以确定热点。先前的研究 我们自己的分析表明，患者按照指导站在垫子上的依从性很高。 意义：远程温度监测(RTM)降低溃疡风险和 截肢来自于在退伍军人事务部外进行的一项小型观察性研究(n=77)，该研究使用了前柱 设计。目前还没有一项随机试验评估过以下项目的有效性或成本/成本节约 不同的高危退伍军人。此外，之前没有任何研究评估过任何患者报告的结果，也没有进行过采访 患者或提供者，这对于了解和解决实施和 传播，如果RTM被证明是有效的。可观的前期成本(每个患者3400美元 每年)促使一些领导人呼吁在退伍军人管理局提供更严格的数据。 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着重要角色。我们的研究将是第一个评估的大型随机对照试验 嵌入医疗保健系统的RTM的有效性。这项研究将告知退伍军人管理局如何与私人 这些公司致力于增进退伍军人的健康和福祉。 具体目标：本研究的具体目标是：1)评估RTM与常规护理的有效性 主要结果(溃疡)和次要结果(溃疡严重程度、截肢、住院、 12个月、18个月和24个月的急诊室就诊、生活质量、护理满意度和患者活跃度)； 收集RTM成本的数据，并与通常的护理成本进行比较，如果证明有效的话；以及3) 评估实施过程，包括在关键利益相关者之间使用的障碍和促进者 指导数据收集和分析的执行研究综合框架。 方法：为达到目标1，我们将进行三点随机对照研究。患者(406例) 在过去24个月内接受DFU或截肢(包括活动性溃疡)的患者将被随机分为1：1 RTM或常规护理(无RTM)，根据种族、乡村和活动性溃疡与非RTM进行随机分层。至 完成目标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；提供者用于选择患者、订购垫子和对“热”警报作出响应的时间 地点“；和利用(与溃疡/截肢有关的门诊、住院和急诊室就诊)。最后，为了 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 以及RTM实施的促进者。 下一步：这项研究的结果将被用来指导有效、高效和公平的RTM扩展 弗吉尼亚州