Biophysical detection of skin changes to cue pressure injury prevention in nursing homes

摘要 压力损伤（PrI）通常位于骨赘上，是皮肤损伤的局部区域， 由于压力和剪切力而引起的皮下软组织。这些痛苦的、危险的、昂贵的、可预防的 疗养院（NH）居民的伤害与生活质量下降和死亡率有关。这 嵌入式实用的阶梯楔形群临床试验，使用混合方法的所有居民， 8 NHs，将检查使用表皮下水分（SEM）评估结果作为护理人员的提示， 启动PrI预防。SEM评估，一种感知皮肤特征变化的生物物理测量， 通过识别PrI的亚临床体征来检测早期压力损伤。SEM的使用是一个创新的补充， 当前根据积极风险评估和/或目视检查启动的PrI预防护理 皮肤变色当观察到红斑或紫色皮肤时，已存在显著损伤。滞后时间 压力引起的组织损伤和皮肤变色的视觉检测之间的关系延迟了护理行动， 预防PrI。肤色较深的人更难辨别变色，使皮肤受损 对于来自少数民族或代表性不足的种族/民族群体的居民，检测比那些 肤色较浅;因此，产生了健康差异。这项研究将把SEM评估纳入PrI 预防护理标准，并在9个月内进行干预。本研究的目的是：1） 确定在目视皮肤观察NH时，通过SEM评估是否检测到早期压力损伤 居民骶骨和足跟区是有效的提示启动NH标准PrI预防; 2）检查 NH标准PrI预防和SEM评估与NH居民特征（年龄， 性别、风险、肤色、种族、民族、BMI、认知状态）及其对NH居民个体的相互作用 关于NH标准PrI预防和PrI发生的启动;以及，3）探索SEM可用性，NH， 和护理人员的特点影响采用和同化的早期PrI检测和随后的 PrI预防措施。目前的NH PrI预防方案和定期安全和护理检查将 执行。样本将包括干预开始时的所有居民和干预期间新入院的居民。 9-月干预期。意向治疗方法将用于对住院医师进行定量分析。 分析中包括整个干预期间积累的数据。将确定提示有效性 通过评估与SEM值和PrI发展相关的PrI预防策略的启动 在干预期间。聚类/重复测量的混合效应回归模型将使用电子 健康记录数据和SEM评估值建模，以预测PrI预防措施的启动。 定性分析将应用于焦点小组数据，并与线索有效性结果进行比较。 研究结果将促进对临床评估PrI风险水平的了解，并有助于未来的重新设计 预防性护理实践和完善PrI预防指南。

Abstract Pressure injuries (PrIs), commonly located over bony prominences, are local areas of damage to the skin and underlying soft tissue caused by pressure and shear forces. These painful, dangerous, costly, and preventable injuries in nursing home (NH) residents are associated with reduced quality of life and mortality. This embedded pragmatic stepped wedge cluster clinical trial, using a mixed-methods approach for all residents in 8 NHs, will examine use of subepidermal moisture (SEM) assessment results as a cue for nursing staff to initiate PrI prevention. SEM assessment, a biophysical measure that senses changes in skin characteristics, detects early pressure damage by identifying subclinical signs of PrI. SEM use is an innovative addition to current PrI prevention care that is currently initiated upon a positive risk assessment and/or a visual inspection of skin discoloration. Significant damage exists by the time erythema or purple skin is observed. Lag time between pressure-induced tissue damage and visual detection of skin discoloration delays nursing actions to prevent PrIs. Discoloration is more difficult to discern in persons with dark skin tones, making skin damage detection more challenging for residents from minority or under-represented racial/ethnic groups than those with lighter skin tones; thus, producing a health disparity. The study will incorporate SEM assessment into PrI prevention standard-of-care and conduct the intervention over a 9-month period. The study aims are to: 1) determine if early pressure damage detected by SEM assessment at time of visual skin observation of NH resident sacral and heel areas is effective in cueing initiation of NH standard PrI prevention; 2) examine the association between NH standard PrI prevention and SEM assessment and NH residents’ characteristics (age, gender, risk, skin tone, race, ethnicity, BMI, cognitive status) and their interactions on individual NH residents with regard to initiation of NH standard PrI prevention and PrI occurrence; and, 3) explore if SEM usability, NH, and nursing staff characteristics influence the adoption and assimilation of early PrI detection and subsequent PrI prevention practices. Current NH PrI prevention protocols and periodic safety and care checks will be performed. Sample will be comprised of all residents at intervention start and those newly admitted during the 9-month intervention period. An intention to treat approach will be used for quantitative analyses with resident data accrued throughout the intervention period included in analyses. Cueing effectiveness will be determined by evaluating the initiation of PrI prevention strategies in relation to SEM values and the development of PrI during the intervention. Mixed effects regression models for clustered/repeated measures will use electronic health record data and SEM assessment values modeled to predict initiation of PrI prevention actions. Qualitative analyses will be applied to focus group data with comparison to cueing effectiveness findings. Study results will advance knowledge about clinically assessed PrI risk-level and contribute to future redesign of preventive nursing practices and refinement of PrI prevention guidelines.