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: 6766885
• 负责人: David Michael Brienza
• 金额: $ 42.22万
• 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/6766885
• 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)是越来越多的美国老年长期护理(LTC)居民面临的一个重大医疗问题。PU降低了生活质量，造成了毁灭性的功能丧失，增加了老年人口的死亡风险，并提高了医疗成本。尽管联邦关于长期护理(LTC)环境的预防性规定，但普遍存在不遵守规定的情况。最近三次医疗保险和医疗补助服务中心(CMS)的LTC调查显示，因未能提供适当的干预措施预防或治疗压疮而发出的传票数量累计增加了21%。在美国，PU的管理成本每年可能超过64亿美元，在LTC人群中的流行率约为28%。据估计，坐着获得的PU在老年、高危人群中的患病率在36-50%之间。包括我们自己的初步调查在内的几项研究支持这些估计，并表明使用旨在减少界面压力的轮椅坐垫将减少坐位获得性PU的发生率。尽管有这些证据，但老年轮椅使用者没有定期接受座椅和定位需求的评估，因为尚未完成明确的研究，以证明为此类座椅干预提供资金的合理性。因此，老年医疗保险受益人无法获得医学上必要和临床上适当的干预措施。取而代之的是，它们通常配备了卷曲的或分段的泡沫垫子，这些垫子并不是为防止压疮而设计的。 拟议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LTC人群坐位获得性压疮方面的有效性。拟议试验的积极结果将提供必要的证据，以改变护理标准，包括对高危居民的座椅和定位需求进行例行评估，并提供减压垫作为预防久坐获得性压疮的措施。如果我们的假设是正确的，这样的干预应该会降低坐位获得性压疮的发生率和流行率，降低医疗费用，并提高生活质量。