Effect of Expanding Barrier Precautions for Reducing Clostridium difficile Acquisition in VA.

背景：美国每年约有170万例，造成严重的发病率， 近十万人死亡艰难梭菌感染（CDI）已成为最常见的医疗保健- 美国医院的HAI导致50万例感染和30，000例死亡。CDI范围 无症状定植、轻度至重度腹泻、伪膜性结肠炎、中毒性巨结肠、结肠炎 穿孔和死亡。CDI的危险因素包括年龄较大、合并症、住院治疗、暴露于他人 CDI和抗生素的使用C.新的流行毒株的出现， 导致了医疗机构的疾病爆发。预防医疗保健发作（HO）CDI已迅速成为 大部分医院优先考虑。医院的预防措施仅限于可改变的风险因素（即，审慎 抗生素的使用和限制接触C. difficile）。医院暴露于C。艰难梭菌可直接发生（即， 医护人员的手或衣服）或间接地（即，环境表面或共用设备）， 预防感染措施重点是医护人员手部卫生、医护人员屏障预防措施 (i.e.,工作服和手套的使用）以及医院环境和可重复使用医疗器械的清洁和消毒 设备.然而，这些干预措施仅限于CDI检测呈阳性的症状性患者。 无症状患者作为交叉污染的储存库，但微生物筛查 无症状携带C. difficile在医疗保健中不是常规进行的。所有患者接触者均戴手套 可能会阻断来自C菌定植的无症状患者的传播。很难 目的：拟议研究的总体目的是确定医护人员的有效性 所有与患者接触时都要戴手套，以减少感染C。住院患者中难治性和院内发生的CDI 医院单位。本研究的主要目的是比较所有患者通用手套的效果 与当前护理标准的接触（即，手套和长袍仅适用于已知的CDI病例）。具体目标是 1)比较所有患者接触的通用手套与当前护理标准对C。艰难 住院患者的获得率; 2）比较通用手套与标准手套的效果， 护理手套对CDI率、其他卫生保健相关感染、30天死亡率和单位住院时间的影响; 3） 评估干预的可信度、成本和利益相关者的经验。 方法：本研究将是一项在10个住院VA医院单位进行的整群随机试验（CRT）。在预- 在干预期间，我们将进行准备工作，包括招募医院，培训研究助理， 确保IRB批准，确定当前实践，最终确定监查和观察计划，并测量 基线C.艰难的收购率。随后是执行CRT的干预期， 医院单位将随机分配，对所有患者接触者实施屏障预防措施，或继续 标准护理（即，已知CDI患者的屏障预防措施）。干预将包括所有 医护人员（护士、医务人员、呼吸治疗师、放射科和实验室技术人员等）利用 为随机接受干预的单位中的所有患者接触者提供手套。非干预 单位将遵循由遵循屏障预防措施的保健工作者组成的护理标准（即，手套 和罩衣）仅用于患有已知CDI和其他耐药性生物体的患者（例如，MRSA）。单位 分析是ICU，因为数据是在单位一级收集的。每月数据将从所有 包括C.艰难梭菌获得和感染率、死亡率、住院时间、屏障 预防措施的遵守情况和最终用户的看法。 影响：对退伍军人医疗保健的预期影响主要是C。收购困难， 随后的感染及其相关的发病率、死亡率和成本。如果发现有效，结果将 改变医疗机构中CDI预防的模式。

Background: Each year approximately 1.7 million occur in the United States causing significant morbidity and nearly 100,000 deaths. Clostridium difficile infection (CDI) has become the most common healthcare- associated infection (HAI) in U.S. hospitals causing half a million infections and 30,000 deaths. CDI ranges from asymptomatic colonization, mild to severe diarrhea, pseudomembranous colitis, toxic megacolon, colonic perforation, and death. Risk factors for CDI include older age, comorbidity, hospitalization, exposure to others with CDI, and antibiotic use. The increasing incidence of C. difficile and emergence of new epidemic strain has resulted in outbreaks in healthcare settings. Prevention of healthcare-onset (HO) CDI has quickly become a priority for most hospitals. Hospital prevention measures are limited to modifiable risk factors (i.e., prudent antibiotic use and limiting exposure to C. difficile). Hospital exposure to C. difficile can occur directly (i.e., hands or clothing of healthcare workers) or indirectly (i.e., environmental surfaces or shared equipment) so infection prevention measures focus on healthcare worker hand hygiene, healthcare worker barrier precautions (i.e., use of gowns and gloves) and cleaning and disinfection of the hospital environment and reusable medical equipment. However, these interventions are limited to symptomatic patients who test positive for CDI. Asymptomatic patients serve as a reservoir for cross contamination, but microbiological screening for asymptomatic carriage of C. difficile is not routinely performed in healthcare. Gloving for all patient contacts may interrupt transmission from asymptomatic patients colonized with C. difficile. Objectives: The overall purpose of the proposed study is to determine the effectiveness of healthcare worker use of gloves for all patient contact for reducing acquisition of C. difficile and hospital-onset CDI in inpatient hospital units. The main objective of the study is to compare the effects of universal gloving for all patient contact to the current standard of care (i.e., glove and gown only for known CDI cases). The specific aims are 1) Compare the effects of universal gloving for all patient contact to the current standard of care on C. difficile acquisition rates in hospitalized patients; 2) Compare the effects of universal gloving compared to standard of care gloving on CDI rates, other healthcare-associated infections, 30-day mortality and unit length of stay; 3) Evaluate intervention fidelity, the cost and stakeholder experiences. Methods: The study will be a cluster randomized trial (CRT) in ten inpatient VA hospital units. In the pre- intervention period we will conduct preparatory work including recruiting hospitals, training research assistants, securing IRB approval, identifying current practices, finalizing monitoring and observation plans and measuring baseline C. difficile acquisition rates. This will be followed by an intervention period executing the CRT in which hospital units will be randomized either to implement barrier precautions for all patient contacts or continue standard care (i.e., barrier precautions for patients with known CDI). The intervention will consist of all healthcare workers (nurses, providers, respiratory therapist, radiology and laboratory technicians, etc.) utilizing gloves for all patient contacts in the units that are randomized to receive the intervention. The non-intervention units will follow standard of care which consists of healthcare workers following barrier precautions (i.e., gloves and gowns) only for patients with known CDI and other antibiotic-resistant organisms (e.g., MRSA). The unit of analysis is the ICU, since data are collected at the level of the unit. Monthly data will be collected from all participating sites including C. difficile acquisition and infection rates, mortality, length of stay, barrier precaution compliance and end-user perceptions. Impact: The anticipated impact on Veterans’ healthcare is primarily the reduction of C. difficile acquisition and subsequent infection and its associated morbidity, mortality and costs. If found to be effective, the results will change the paradigm for CDI prevention in healthcare settings.