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生活质量降低相关。然而，解决这一问题的预防性干预措施很少受到研究关注。为了解决这一差距，我们将调查一种有前途的生活方式干预的有效性，旨在预防SCI人群中高危成员的压疮。这项为期五年的研究将涉及南加州大学（USC）和Rancho Los Amigos国家康复中心（RLANRC）的研究人员之间的合作，他们根据对SCI成年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方案，可以提高成年SCI患者的健康和生活质量，同时减轻SCI相关压疮问题造成的沉重医疗负担。拟议研究的具体目标是：（a）进行一项随机临床试验，以了解干预措施降低高级别发生率的能力。（3或4期）SCI成人患者的压疮;（B）评估干预的成本效益和潜在的成本节约;（c）检查干预对参与者生活质量的影响;以及（d）模拟调节干预效果的过程机制。为了实现这些目标，将在一家大型康复机构招募160名SCI后至少6个月且至少有一次严重压疮病史的不同种族男性和女性（包括讲英语和西班牙语的人），并随机分配至12个月的基于生活方式的干预条件或标准护理控制条件。干预措施将包括家访和电话，目的是为每位客户制定个性化的压疮预防计划。在完成试验的干预阶段后，将对研究受试者进行为期一年的随访。结果分析将测试干预是否降低新的严重溃疡的发生率，减少手术和其他与溃疡相关的医疗费用，和/或提高生活质量。该项目将通过提高由于压力性溃疡问题而处于患病和住院高风险的一大部分人的身心健康来有益于公共卫生。如果成功，干预措施有能力产生大量的财政储蓄，从而有助于抵消社会不断上升的医疗保健费用。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，并且与极高的治疗成本和降低的生活质量相关。在这项研究中，我们将测试一种生活方式干预，有望显着减少脊髓损伤成人人群的压疮。

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.