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: 7232710
• 负责人: David Michael Brienza
• 金额: $ 35.19万
• 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 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7232710
• 关键词: Caring; Cessation of life; Clinical; Clinical Trials Data Monitoring Committees; Decubitus ulcer; Elderly; End Point; Equipment; Equipment and supply inventories; Evaluation; Failure; Funding; Health Care Costs; Healthcare; Incidence; Intervention; Investigation; Level of Evidence; Long-Term Care; Long-Term Care for Elderly; Manuals; Measures; Medicare; Monitor; Numbers; Operative Surgical Procedures; Participant; Patient Monitoring; Patients; Phase; Pilot Projects; Population; Populations at Risk; Positioning Attribute; Prevalence; Prevention; Preventive; Primary Prevention; Protocol Compliance; Protocols documentation; Publishing; Quality of life; Randomized; Range; Rate; Recruitment Activity; Research; Research Personnel; Research Training; Risk; Sample Size; Specialist; Standards of Weights and Measures; Surveys; Testing; Time; United States; United States Centers for Medicare and Medicaid Services; Wheelchair fitting; Wheelchairs; Work; Writing; beneficiary; clinical research site; cost; design; improved; loss of function; medically necessary care; patient safety; prescription document; prescription procedure; pressure; prevent

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）是美国（US）老年长期护理（LTC）居民日益增多的一个重要的医疗保健问题。PU降低了生活质量，造成了毁灭性的功能丧失，增加了老年人群的死亡风险，并提高了医疗成本。尽管联邦政府对长期护理（LTC）设定了预防性规定，但普遍存在不遵守规定的情况。最近三个医疗保险和医疗补助服务中心（CMS）的LTC调查显示，由于未能提供适当的干预措施来预防或治疗压疮而发出的传票数量累积增加了21%。在美国，每年用于PU管理的费用可能超过64亿美元，在LTC人群中患病率约为28%。据估计，老年高危人群中坐着获得性PU的患病率在36-50%之间。包括我们自己的试点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缓冲垫将减少坐位获得性PU的发生率。尽管有这些证据，老年人轮椅使用者的座位和定位需求并没有常规评估，因为还没有完成明确的研究来证明为这种座位干预提供资金是合理的。因此，老年医疗保险受益人无法获得医疗上必要和临床上适当的干预措施。相反，他们通常使用的是卷曲或分段泡沫垫，这些垫不是为预防压疮而设计的。