RCT on preventing pressure ulcers with seat cushions

使用座垫预防压疮的随机对照试验

• 批准号: 6611866
• 负责人: David Michael Brienza
• 金额: $ 47.23万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-25 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6611866
• 关键词: aging; assistive device /technology; clinical research; clinical trials; decubitus ulcer; disease /disorder prevention /control; extended care; geriatric nursing; geriatrics; human old age (65+); human subject; human therapy evaluation; patient oriented research; quality of life; skin ulcer; therapy

DESCRIPTION (provided by applicant): Pressure ulcers (PU) are a significant healthcare problem for the growing number of United States (US) elderly long-term care (LTC) residents. PU diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Despite Federal preventive mandates for the long-term care (LTC) setting, widespread non-compliance occurs. The last three Centers for Medicare and Medicaid Services (CMS) LTC surveys showed a cumulative increase of 21% in the number of citations issued for failure to provide proper intervention to prevent or treat pressure ulcers. Costs for the management of PU in the US likely exceed $6.4 billion annually, with a prevalence of approximately 28% in the LTC population. Estimates of the prevalence of sitting-acquired PU in the elderly, at-risk population range from 36-50%. Several studies, including our own pilot investigation, support these estimates and have suggested that the use of wheelchair cushions designed to reduce interface pressure will reduce the incidence of sitting-acquired PU. Despite this evidence, elderly wheelchair users are not routinely evaluated for seating and positioning needs because definitive studies have not been completed to justify funding for such seating interventions. Consequently, elderly Medicare beneficiaries are being denied access to medically necessary and clinically appropriate interventions. Instead, they are most frequently provided with convoluted or segmented-foam cushions that are not designed for pressure ulcer prevention. The primary aim of the proposed multi-center, randomized pressure-reducing wheelchair cushion trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, LTC population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of a pressure-reducing cushion as a preventive measure against sitting acquired pressure ulcers. If our hypothesis is correct, such an intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.

描述（由申请人提供）：压疮（PU）是越来越多的美国（US）老年长期护理（LTC）居民面临的一个重大医疗保健问题。PU会降低生活质量，造成严重的功能丧失，增加老年人群的死亡风险，并增加医疗费用。尽管联邦对长期护理（LTC）环境的预防任务，广泛的不遵守发生。最近三次医疗保险和医疗补助服务中心（CMS）LTC调查显示，因未能提供适当干预以预防或治疗压疮而发出的引文数量累计增加了21%。在美国，PU的管理成本每年可能超过64亿美元，在LTC人群中的患病率约为28%。在老年高危人群中，坐位获得性PU的患病率估计为36- 50%。几项研究，包括我们自己的试点调查，支持这些估计，并建议使用轮椅垫，旨在减少界面压力将减少坐着获得PU的发生率。尽管有这样的证据，老年轮椅使用者的座位和定位的需要，因为没有完成明确的研究，以证明这种座位干预资金的常规评估。因此，老年医疗保险受益人被剥夺了获得医疗必要和临床适当干预的机会。相反，他们最经常提供回旋或分段泡沫垫，不是设计用于预防压疮。 拟定的多中心、随机减压轮椅垫试验（PRWC-II）的主要目的是确定减压垫在预防老年人（LTC人群）坐位获得性压疮方面的疗效。拟议试验的积极结果将提供改变护理标准所需的证据水平，包括对有风险的居民进行常规评估，以满足其坐姿和体位需求，并提供减压垫作为预防坐姿获得性压疮的措施。如果我们的假设是正确的，这样的干预应该会导致坐着获得性压疮的发病率和患病率下降，降低医疗费用，提高生活质量。