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

背景：美国每年约有170万人发生，导致严重的发病率和 近10万人死亡。艰难梭菌感染(CDI)已成为最常见的医疗保健- 美国医院的相关感染(HAI)导致50万人感染和30,000人死亡。CDI范围 从无症状的定植，轻度到重度腹泻，伪膜性结肠炎，中毒性巨结肠，结肠 穿孔和死亡。CDI的危险因素包括高龄、合并症、住院、接触他人 CDI和抗生素的使用。艰难梭菌发病率的增加和新流行菌株的出现 导致了医疗保健环境的暴发。预防保健发病(HO)CDI已迅速成为 对大多数医院来说都是优先事项。医院预防措施仅限于可改变的风险因素(即审慎 使用抗生素和限制艰难梭菌的暴露)。医院暴露于艰难梭菌可直接发生(即， 医护人员的手或衣服)或间接(例如，环境表面或共享设备) 感染预防措施的重点是医护人员的手部卫生，医护人员屏障预防 (例如，使用睡袍和手套)以及医院环境和可重复使用的医疗设施的清洁和消毒 设备。然而，这些干预措施仅限于CDI检测呈阳性的有症状的患者。 无症状的患者是交叉污染的蓄水池，但微生物筛查 艰难梭菌的无症状携带在医疗保健中并不常见。为所有患者接触者戴手套 可能会阻断感染艰难梭菌的无症状患者的传播。 目标：拟议研究的总体目的是确定医护人员的有效性 对所有患者接触者使用手套，以减少住院患者艰难梭菌的感染和院内CDI 医院单位。这项研究的主要目的是比较所有患者戴通用手套的效果 接触目前的护理标准(即，只有在已知的CDI病例中才戴手套和穿长袍)。具体目标是 1)比较所有接触患者的通用手套与目前治疗艰难梭菌的标准的效果 住院患者的获得率；2)比较通用手套和标准手套的效果 护理手套对CDI发病率、其他与医疗保健相关的感染、30天死亡率和单位住院时间；3) 评估干预保真度、成本和利益相关者体验。 方法：这项研究将在10个住院退伍军人医院单元中进行整群随机试验。在这之前- 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， 确保内部审查委员会的批准，确定当前的做法，最终确定监测和观察计划并进行测量 艰难梭菌的基线获得率。这之后将是执行CRT的干预期 医院单元将随机进行，要么对所有患者接触者实施屏障预防措施，要么继续 标准护理(即，已知CDI患者的屏障预防措施)。干预行动将包括所有 医护人员(护士、提供者、呼吸治疗师、放射科和实验室技术员等)利用 随机化接受干预的单元中所有患者接触者的手套。不干预 医疗单位将遵循护理标准，由医护人员遵循屏障预防措施(即手套) 和长袍)仅适用于已知的CDI患者和其他耐药微生物(如MRSA)。单位： 分析是重症监护室，因为数据是在单位一级收集的。每月的数据将从所有 参与地点包括艰难梭菌的获得率和感染率、死亡率、住院时间、屏障 预防措施、合规性和最终用户的看法。 影响：对退伍军人医疗保健的预期影响主要是艰难梭菌收购和 随后的感染及其相关的发病率、死亡率和费用。如果被发现是有效的，结果将 改变医疗机构预防CDI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.