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

扩大屏障预防措施对减少 VA 中艰难梭菌感染的影响。

• 批准号: 10641758
• 负责人: NASIA SAFDAR
• 金额: --
• 依托单位: WM S. MIDDLETON MEMORIAL VETERANS HOSP
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10641758
• 关键词: Admission activity; Affect; American; Antibiotic-resistant organism; Antibiotics; Antimicrobial Resistance; Antisepsis; Biological; Caring; Cessation of life; Clostridium difficile; Clothing; Cluster randomized trial; Colon; Communicable Diseases; Communities; Containment; Data; Decontamination; Diagnostic tests; Diarrhea; Disease; Disease Outbreaks; Disinfection; Environment; Environmental Pollution; Equipment; Exposure to; Goals; Hand; Health; Health Personnel; Health care facility; Healthcare; Hospital Units; Hospitalization; Hospitals; Hygiene; Incidence; Infection; Infection Control; Infection prevention; Inpatients; Institutional Review Boards; Interruption; Intervention; Laboratory Technicians; Length of Stay; Measures; Medical; Methods; Microbiology; Monitor; Morbidity - disease rate; Nurses; Organism; Patients; Patients' Rooms; Perception; Perforation; Prevention; Prevention Measures; Provider; Pseudomembranous Colitis; Radiology Specialty; Randomized; Recommendation; Reproduction spores; Research; Research Assistant; Research Training; Resistance; Resources; Risk Factors; Secure; Site; Societies; Surface; Testing; Time; Toxic Megacolon; United States; Veterans; Work; comorbidity; cost; diarrheal disease; effectiveness evaluation; evidence based guidelines; experience; health care settings; healthcare-associated infections; human old age (65+); improved; infection rate; infection risk; methicillin resistant Staphylococcus aureus; modifiable risk; mortality; multi-drug resistant pathogen; new epidemic; pathogen; patient safety; prevent; programs; public health priorities; recruit; respiratory; screening; standard care; standard of care; transmission process

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.

背景：美国每年大约有 170 万起此类事件，造成严重的发病率和 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 3 万人死亡。 CDI范围 从无症状定植、轻度到重度腹泻、伪膜性结肠炎、中毒性巨结肠、结肠 穿孔、死亡。 CDI 的危险因素包括年龄较大、合并症、住院治疗、与他人接触 与 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 导致医疗机构爆发疫情。预防医疗保健发病 (HO) CDI 已迅速成为一项 大多数医院的优先考虑。医院预防措施仅限于可改变的风险因素（即谨慎的 抗生素的使用和限制艰难梭菌的暴露）。医院可能会直接接触艰难梭菌（即， 医护人员的手或衣服）或间接（即环境表面或共用设备），以便 感染预防措施重点关注医护人员手部卫生、医护人员屏障预防措施 （即使用隔离衣和手套）以及医院环境的清洁和消毒以及可重复使用的医疗器械 设备。然而，这些干预措施仅限于 CDI 检测呈阳性的有症状患者。 无症状患者是交叉污染的储存库，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规进行。为所有患者接触者佩戴手套 可能会中断艰难梭菌定植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 在所有与患者接触的过程中使用手套，以减少住院患者感染艰难梭菌和医院发病的 CDI 医院单位。该研究的主要目的是比较通用手套对所有患者的影响 接触当前的护理标准（即仅在已知的 CDI 病例中使用手套和长袍）。具体目标是 1) 比较所有接触患者的通用手套与当前艰难梭菌护理标准的效果 住院患者的感染率； 2) 比较通用手套与标准手套的效果 护理手套了解 CDI 发生率、其他医疗保健相关感染、30 天死亡率和单位住院时间； 3） 评估干预的保真度、成本和利益相关者的体验。 方法：该研究将是在 10 个住院 VA 医院单位进行的整群随机试验 (CRT)。在预 干预期我们将进行准备工作包括招募医院、培训研究助理、 获得 IRB 批准、确定当前做法、最终确定监测和观察计划并进行测量 基线艰难梭菌采集率。接下来是执行 CRT 的干预期，其中 医院单位将被随机分配，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（即对已知 CDI 患者采取屏障预防措施）。干预措施将包括所有 医护人员（护士、提供者、呼吸治疗师、放射科和实验室技术人员等）利用 为随机接受干预的单位中的所有患者接触者戴上手套。不干预 单位将遵循护理标准，其中包括医护人员遵循屏障预防措施（即戴手套 和长袍）仅适用于已知患有 CDI 和其他抗生素耐药微生物（例如 MRSA）的患者。单位为 分析是 ICU，因为数据是在单位级别收集的。每月数据将从所有 参与地点包括艰难梭菌获得和感染率、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减少艰难梭菌的获取和 随后的感染及其相关的发病率、死亡率和费用。如果发现有效的话，结果将 改变医疗机构中 CDI 预防的范式。