PROTECT Trial: Protecting nursing home residents from infections and readmissions

 描述(由申请人提供)：美国疗养院的300万美国人每年经历令人震惊的200-300万与医疗保健相关的感染。这些感染每年导致超过15万人重新入院，超过38万人死亡。疗养院照顾感染风险高的人，因为老年、创伤、医疗器械和合并症的发病率很高。疗养院还接纳许多居民携带多重耐药生物(MDRO)，如耐甲氧西林金黄色葡萄球菌(MRSA)、耐万古霉素肠球菌(VRE)和新出现的泛耐药革兰氏阴性杆菌，这些细菌会导致严重和致命的疾病。这些病原体具有在疗养院居民中传播的相关风险。接触预防和隔离是医院感染控制的支柱，但对于疗养院来说，接触预防和隔离并不能提供切实可行的解决方案，因为在疗养院，社会化和类似家庭的环境是康复和生活质量的关键组成部分。非殖民化战略可能提供一种简单、低成本的解决方案，通过减少可能导致感染的体表细菌来预防感染和重新入院。我们的研究团队最近在医院重症监护病房进行了一项大型务实群组随机临床试验，评估了非殖民化的效果，发现使用杀菌皂和鼻膏的局部非殖民化将耐多药细菌的负担减少了三分之一以上，并将血液感染减少了近一半。我们将在这一经验的基础上，为养老院的日常事务量身定做一份非殖民化议定书。我们将检验这一假设，即非殖民化可能保护疗养院居民免受感染和再次住院。我们还将评估其在减少多重耐药生物的生物边界方面的潜在好处。PROTECT试验将依靠一个由具有传染病、感染预防、老年病、疗养院护理和管理、护理教育和生物统计学专业知识的研究人员组成的多学科团队，进行一项大型的整群随机试验 在疗养院实现非殖民化，有可能降低这一弱势群体因医疗保健相关感染而导致的大量发病率。

 DESCRIPTION (provided by applicant): The 3 million Americans in U.S. nursing homes experience a staggering 2-3 million healthcare- associated infections each year. These infections result in over 150,000 readmissions and over 380,000 deaths annually. Nursing homes care for persons at high risk for infection due to the high prevalence of older age, wounds, medical devices, and comorbidities. Nursing homes also admit many residents that harbor multi- drug resistant organisms (MDROs), such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE), and emerging pan-resistant gram negative rods that cause serious and deadly disease. These pathogens carry associated risks for transmission among nursing home residents. Contact precautions and isolation, the mainstays of infection control in hospitals, do not provide a practical solution for nursing homes where socialization and a home-like environment are key components of recovery and quality of life. Decolonization strategies may provide a simple and low-cost solution to prevent infection and readmissions by reducing body surface bacteria that can cause infection. Our investigative team recently evaluated the effect of decolonization in a large pragmatic cluster- randomized clinical trial in hospital intensive care units and found that topical decolonization with antiseptc soap and nasal ointments reduced the burden of multi-drug resistant bacteria by over one-third and reduced bloodstream infections by nearly one-half. We will build on this experience to tailor a decolonization protocol to nursing home routines. We will test the hypothesis that decolonization might protect nursing home residents from infection and hospital readmission. We will also evaluate its potential benefit in decreasing the bioburden of multi-drug resistant organisms. The PROTECT Trial will rely upon a multi-disciplinary team of researchers with expertise in infectious diseases, infection prevention, geriatrics, nursing home care and administration, nursing education, and biostatistics to conduct a large cluster-randomized trial of decolonization in nursing homes that has the potential to decrease the substantial morbidity due to healthcare-associated infections in this vulnerable population.