LIFESTYLE REDESIGN FOR PRESSURE ULCER PREVENTION IN SCI

描述（由申请人提供）：晚期压疮是脊髓损伤（SCI）的常见和医学上严重的并发症，与极高的治疗费用和降低的生活质量有关。然而，针对这一问题的预防性干预措施得到的研究关注很少。为了解决这一差距，我们将研究一种有希望的生活方式干预的有效性，该干预旨在预防脊髓损伤高危人群中的压疮。这项为期五年的研究将由南加州大学（USC）和Rancho Los Amigos国家康复中心（RLANRC）的研究人员合作进行，他们根据对SCI成人生活方式和溃疡风险的定性调查结果开发了干预措施。该项目的长期目标是确定一种干预选择，可以提高脊髓损伤成人人群的健康和生活质量，同时减少由脊髓损伤相关压疮问题引起的沉重医疗负担。拟议研究的具体目的是：(a)进行一项随机临床试验，以研究干预措施降低脊髓损伤成人患者高级别（3期或4期）压疮发生率的能力；(b)评估干预措施的成本效益和可能节省的成本；(c)检查干预措施对参与者生活质量的影响；(d)模拟调解干预效果的过程机制。为了实现这些目标，160名不同种族的男性和女性（包括说英语和西班牙语的人），他们在脊髓损伤后至少6个月，之前至少有一次严重压疮的病史，将在一家主要的康复机构招募，并随机分配到12个月的生活方式干预条件或标准护理控制条件。干预将包括家访和电话，目的是为每个客户制定一个个性化的计划，以预防压疮。研究参与者将在试验干预阶段结束后进行为期一年的随访。结果分析将测试干预是否减少了新的严重溃疡的发生率，减少了手术和其他与溃疡相关的医疗费用，和/或提高了生活质量。该项目将有利于公共卫生，因为它提高了大部分因压疮问题而患病和住院风险很高的个人的身心健康。如果成功，该干预措施有能力节省大量资金，从而有助于抵消社会不断上升的医疗成本。公共卫生相关性：医学上严重的压疮是脊髓损伤的常见并发症，与极高的治疗费用和生活质量下降有关。在这项研究中，我们将测试一种生活方式干预，它有望显著减少脊髓损伤成人人群中的压疮。

DESCRIPTION (provided by applicant): Advanced pressure ulcers are a common and medically serious complication of spinal cord injury (SCI) and are associated with extremely high treatment costs and reduced quality of life. However, preventive interventions that address this problem have received very little research attention. To address this gap, we will investigate the efficacy of a promising lifestyle intervention designed to prevent pressure ulcers among at-risk members of the SCI population. The resulting five-year study will involve collaboration between researchers from the University of Southern California (USC) and Rancho Los Amigos National Rehabilitation Center (RLANRC), who have developed the intervention based on the results of a qualitative investigation of lifestyle and ulcer risk among adults with SCI. The long-term objective of this project is to identify an intervention option that can enhance the health and life quality of the population of adults with SCI while simultaneously diminishing the heavy healthcare burden that results from the problem of SCI-related pressure ulcers. The specific aims of the proposed research are to: (a) conduct a randomized clinical trial of the intervention's ability to reduce the incidence of high grade (Stage 3 or 4) pressure ulcers in adults with SCI; (b) assess the cost-effectiveness and potential cost savings of the intervention; (c) examine the intervention's effects on participants' quality of life; and (d) model the process mechanisms that mediate the effects of the intervention. To accomplish these aims, 160 ethnically diverse men and women (including English and Spanish speakers) who are at least 6 months post-SCI and who have a history of at least one previous severe pressure ulcer will be recruited at a major rehabilitation facility and randomly assigned to either a 12- month lifestyle-based intervention condition or a standard care control condition. The intervention will consist of in-home visits and phone calls, with the intent to develop for each client a personalized plan for pressure ulcer prevention. Study participants will be followed for one year following the completion of the intervention phase of the trial. Outcome analyses will test whether the intervention reduces the incidence of new serious ulcers, reduces surgeries and other ulcer-linked medical treatment costs, and/or enhances quality of life. The project will benefit public health by increasing the physical and emotional wellness of a large sector of individuals who are at high risk for sickness and hospitalization due to the pressure ulcer problem. If successful, the intervention has the capacity to generate large financial savings and thereby help counteract society's rising healthcare costs. PUBLIC HEALTH RELEVANCE: Medically serious pressure ulcers are a common complication of spinal cord injury and are associated with extremely high treatment costs and reduced quality of life. In this study we will test a lifestyle intervention that promises to significantly reduce pressure ulcers in the population of adults with spinal cord injury.