Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,856
- 试验地点
- 1
- 主要终点
- Number of ICU Patients Who Acquire VRE or MRSA
研究概览
简要总结
This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will:
- Decrease the chance of patients getting an infection while in the hospital
- Decrease the chance of patients picking up bacteria as a result of being in the hospital
- Decrease the time a patient spends in the ICU or in the hospital
- Increase the frequency of adverse events
The study will also look at whether making doctors, nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients.
This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients.
This study will provide information that will help to make being in the hospital safer for all patients.
详细描述
GOAL:
The overall goal of this project is to determine the effectiveness of universal glove and gowning procedures in reducing healthcare-associated infection (HAI) rates and acquisition of antibiotic-resistant bacteria in the Intensive Care Unit (ICU). More specifically, this project requires that a cluster-randomized trial (CRT) be designed and conducted to compare the effects of universal glove and gowning procedures as compared to the current standard of care in ICUs.
STUDY DESIGN: The study is a two arm, cluster-randomized trial. Randomization and analysis will be performed at the ICU level. A secondary statistical analysis will be performed at the patient level.
STUDY POPULATION: Adult patients in medical, surgical or combined medical/surgical ICUs.
SAMPLE SIZE: Based on the power calculations presented in Appendix I for each of the CRT aims, the study will use at least 18 ICU sites, half for the universal gown and glove intervention and half for CDC standards of care only. We will seek to maximize the number of ICUs involved to improve the scientific value of the study. The study is presently powered for a 1-year intervention study if 18 ICUs are included. After the 2 month pre-randomization period, we will use the actual number of sites enrolled and our baseline estimates to see if we can achieve the same degree of power for a study intervention of less than a year.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICUs to be included are: adult medical, surgical or combined medical surgical ICU as defined below:
- •Medical ICU (MICU) > 80% of patients have a medical condition and have not undergone a surgical procedure during the current hospital stay
- •Surgical ICU (SICU) > 80% of the patients have undergone a surgical procedure during the current hospital stay
- •Combined Medical/Surgical ICU (MICU/SICU) - a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during the current hospital stay. Each group makes up > 20% and less than 80% of the total number of patients
- •Ability to collect the data required for analysis
- •Written approval of the study from the institution's IRB. The institution may opt to use the IRB approval provided by the centralized IRB at the University of Maryland, School of Medicine
- •Memorandum of Understanding signed by the ICU Medical Director, ICU Nurse Manager or Director and the Hospital Epidemiologist indicating a commitment to supporting enrollment of an ICU and completion the study
- •Ability to be matched with another ICU based on baseline acquisition of resistant bacteria on culture
- •Agreement to not perform active surveillance for MRSA or VRE that will be fed back to patients during the study period
排除标准
- •Pediatric ICUs and other non-medical or non-surgical ICUs will be excluded
结局指标
主要结局
Number of ICU Patients Who Acquire VRE or MRSA
时间窗: 9 months
The outcome of interest is the acquisition of VRE or MRSA as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA. The outcomes will be analyzed both individually and collectively. Acquisition will be defined as: 1. A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen. 2. Subsequent discharge surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen.
次要结局
- Changes from Baseline in 30-day Mortality Rate(9 months)
- Number of ICU Patients Who Acquire CABSI(9 months)
- Number of ICU Patients Who Acquire VAP(9 months)
- Changes from Baseline in ICU LOS(9 months)
- Number of Adverse Events Occuring in the ICU(9 months)
- Number of ICU Patients Who Acquire CAUTI(9 months)
研究者
Anthony Harris
Professor
University of Maryland, Baltimore