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.
External Links for this Project
Grant Number: I01HX002666-01A1
None at this time.
Health Systems, Infectious Diseases
Treatment - Implementation, TRL - Applied/Translational
Models of Care
None at this time.