By Kelly M. Pyrek
Editor’s note: This is the first in a two-part series examining the clinical and fiscal aspects of making the case for environmental hygiene. This article originally appeared in the January 2020 issue of Healthcare Hygiene magazine.
As Palmore and Henderson (2015) acknowledge, “The relative role that the environment plays in the transmission of HAIs has been a topic of decades-long debate, with persons in the healthcare epidemiology community vacillating between skepticism and conviction. Unlike near-universal acceptance of the importance of hand hygiene, the prevailing view of the contribution of the inanimate health care environment to the spread of HAIs has swung back and forth like a pendulum. Both cultural shifts and new studies have elicited opposing opinions about the role of the environment in HAI transmission and the corollary role of disinfection in reducing these infections. Convincing health care personnel to clean their hands at every opportunity is challenging but maintaining a hospital environment that is free from contamination is perhaps even more difficult.
A major challenge in determining the precise contributions of the environment to HAI transmission, Palmore and Henderson (2015) add, “is the difficulty of designing studies that are capable of yielding high-quality data (including patient-centered outcomes).”
The lack of rigorous evidence supporting the role of environmental hygiene was addressed several years ago in a study published in The Annals of Internal Medicine, when researchers at the University of Pennsylvania School of Medicine emphasized that more evidence was needed to identify best methods to clean hospital rooms and thereby prevent infections.
This systematic overview pointed to several promising cleaning tactics for high-touch surfaces but acknowledged a lack of evidence as to which is the most effective at reducing healthcare-associated infections (HAIs). Few studies measured patient outcomes or focused on newer technologies, and even less compared cleaning tactics against one another—important gaps to fill as the U.S. healthcare system works to reduce the 75,000 HAI-related deaths that occur annually.
The review, led by Craig A. Umscheid, MD, MSCE, an assistant professor of medicine and epidemiology in the Perelman School of Medicine at the University of Pennsylvania, Jennifer Han, MD, MSCE, an assistant professor of medicine and epidemiology, along with Brian Leas, MS, MA, and Nancy Sullivan, research analysts in the ECRI-Penn AHRQ EPC, revealed major gaps in existing evidence for the best practices for cleaning hospital room surfaces to prevent HAIs and revealed major gaps in existing evidence for the best practices for cleaning hospital room surfaces to prevent HAIs.
"The cleaning of hard surfaces in hospital rooms is critical for reducing HAIs," said Han. "We found that the research to date does provide a good overall picture of the before and after results of particular cleaning agents and approaches to monitoring cleanliness. Researchers now need to take the next step and compare the various ways of cleaning these surfaces and monitoring their cleanliness in order to determine which are the most effective in driving down the rate of hospital-acquired infections."
Examining 80 studies, the research team found that comparative effectiveness studies were uncommon. Such studies would have directly compared different ways of cleaning, disinfecting, and monitoring the cleanliness of hard surfaces in order to determine which were most effective. There were also relatively few studies that focused on measuring outcomes of most interest to patients, such as changes in HAI rates or the presence of pathogens on patients. Only five of the studies were randomized controlled trials. Instead, the existing studies were largely before and after experiments, comparing the magnitude of surface contamination after cleaning with an agent to the magnitude of contamination before cleaning. More than 65 percent of the studies assessed surface contamination, such as bacterial burden and colony counts, as the primary outcome. Less than 35 percent reported on patient-centered outcomes, such as HAI rates or acquisition of a specific organism in the body, known as colonization.
The researchers examined three broad categories of evidence: which agents and methods were used to clean hard surfaces; what approaches were available to monitor the effectiveness of cleaning; and what systems-level factors are needed for cleaning and monitoring to be successful.
"Our goal was to provide a comprehensive review of evidence in all three domains," said Umscheid. "While there is a clear need for more patient-centered and comparative effectiveness research, the findings that do exist provide a good place to start in terms of a hospital or health care entity seeking information on ways to mitigate healthcare-associated infections."
Among its findings, the researchers identified several studies showing that rates of C. difficile fell with the use of bleach-based disinfectants but that a chlorine dioxide-based product was ineffective in reducing C. diff contamination and infection rates. In addition, six studies integrating various wipes moistened with hydrogen peroxide and other chemicals into preventive strategies reported positive outcomes, including sustained reductions in HAIs. Seventeen studies implementing "no-touch" modalities to clean hard surfaces -- such as devices that emit ultraviolet light or hydrogen peroxide vapor -- reported positive findings, with three specifically demonstrating reductions in infection rates. Seven of eight studies evaluating enhanced coatings on hospital room surfaces, such as copper-coated bed rails, reported positive findings. Surfaces made of solid, copper-based metals or alloys continuously kill bacteria that cause infections.
The researchers also highlighted several priority areas for future research, based on their review of the evidence and interviews with leading experts. As Han, et al. (2015) note, “Future research on environmental cleaning and disinfecting to reduce HAIs should address the following key questions: What surfaces, including high-touch objects, should be cleaned and disinfected? How should surfaces be cleaned and disinfected, and what is the comparative effectiveness of different methods? How should cleaning and disinfecting be monitored and measured, and what would be appropriate benchmarks for cleanliness and reduced risk for pathogen transmission? How should interventions be implemented, including in-depth study of facilitators and barriers to real-world implementation?”
"In addition to expanding the use of comparative effectiveness research and placing greater emphasis on patient-centered outcomes, future research should investigate the effectiveness of a number of promising new technologies and approaches," said Han. "These include self-disinfecting coatings and increasingly used surface markers for monitoring the presence of pathogens. Other challenges include identifying high-touch surfaces that confer the greatest risk of pathogen transmission and developing standard thresholds for defining cleanliness."
As Han, et al. (2015) note: “We found considerable diversity regarding both study design and cleaning/disinfecting and monitoring methods examined across studies, as well as many limitations in the evidence base. There was a lack of direct, rigorous comparative studies of various methods, with only five studies designed as randomized, controlled trials. Our review of the literature also highlighted a limited focus on patient-centered outcomes, such as patient colonization or infection. Instead, surface contamination was the most commonly reported outcome.”
The results of these studies suggest that evaluating the clinical effectiveness of cleaning and disinfecting methods is challenging. As the researchers explain, “A major limitation is the gap between optimized use of surface cleaning or disinfecting agents in studies and practical implementation in real-world settings (such as appropriate dwell time and type of surface targeted). Manufacturers provide recommendations for proper use of their products, but most studies do not report thoroughness of cleaning or adherence to disinfectant dwell time; this information also remains largely unknown in daily practice. An important related concern is uncertainty by end users about the applicability of some manufacturer recommendations. Guidance that accompanies products may be based on laboratory testing under ideal conditions rather than clinical settings. Recommendations may also be developed based on certain types of pathogens, but users may choose to implement a product or technology for broader effects. Few studies directly compared the effectiveness of different methods; instead, many used before-and-after study designs to assess the effect of a single disinfecting method.”
Another challenge to interpreting the results of the current evidence base, according to Han, et al. (2015) is determining the specific effect of environmental cleaning and disinfecting interventions in the context of multicomponent infection prevention strategies: “Infection prevention comprises many critical components in addition to hard surface cleaning, including sterilization of instruments, implementation of appropriate isolation precautions, and proper hand hygiene. These and other elements may sometimes be included as interventions within a larger infection prevention strategy, limiting the ability to discern the specific effect of any single approach. These factors also have the potential to modify the effectiveness of environmental cleaning interventions. Considerable uncertainty also remains about which surfaces, including high-touch objects, should be targeted for cleaning and disinfecting.”
Four years after Han, et al. (2015)’s summation of the paltry evidence, Mitchell, et al. (2019) published their multicenter, randomized trial, known as the REACH study, evaluating the effectiveness of an environmental cleaning bundle to reduce HAIs in hospitals.
The Researching Effective Approaches to Cleaning in Hospitals (REACH) study was a pragmatic trial conducted in 11 acute-care hospitals in Australia having more than 200 inpatient beds and a HAI surveillance program. The stepped-wedge design meant intervention periods varied from 20 weeks to 50 weeks. The researchers introduced the REACH cleaning bundle -- a multimodal intervention, focusing on optimizing product use, technique, staff training, auditing with feedback, and communication -- for routine cleaning. The primary outcomes were incidences of health-care-associated Staphylococcus aureus bacteremia, Clostridium difficile infection, and vancomycin-resistant enterococci infection. The secondary outcome was the thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel.
In the pre-intervention phase, the authors reported 230 cases of VRE infection, 362 of S. aureus bacteremia, and 968 C. difficile infections, for 3,534,439 occupied-bed days. During the intervention, there were 50 cases of VRE infection, 109 of S. aureus bacteremia, and 278 C. difficile infections, for 1,267,134 occupied-bed days. After the intervention, VRE infections reduced from 0.35 to 0.22 per 10,000 occupied-bed days, while the incidences of S. aureus bacteremia (0.97 to 0.80 per 10,000 occupied-bed-days) and C. difficile infections (2.34 to 2.52 per 10,000 occupied-bed days) did not change significantly. The intervention increased the percentage of frequent touch points cleaned in bathrooms from 55 percent to 76 percent and patient rooms from 64 percent to 86 percent.
As Mitchell, et al. (2019) emphasize, “The intervention does not require new technology, but prioritizes evidence from previous studies based on feasibility and cost of implementation, using an implementation science framework to guide application. This bundle has the potential to be implemented into various hospital settings. The findings from our real-world study suggest that improving hospital cleaning requires a multi-modal, tailored approach that considers the local setting. By using a bundle approach to improve routine and discharge cleaning, improved cleaning performance and a reduction in the number of VRE infections is possible. Since VRE is a useful surrogate for other bacteria, there are potential benefits of a tailored cleaning bundle for other pathogens that survive in the environment. However, we found no effect of the cleaning bundle on Staphylococcus aureus bacteremia and Clostridium difficile.”
The REACH bundle— created via a review of peer-reviewed publications and guidelines, prioritization of evidence by an expert panel (with a focus on interventions that were easy to implement and low cost) --makes recommendations on optimal types of cleaning agents, frequency of cleaning, cleaning techniques, auditing strategies, environmental cleaning staff training, and creating a hospital-wide commitment to improved cleaning.
Brett Mitchell, PhD, FACN, FACIPC, CIPC-E, a professor in the School of Nursing and Midwifery, at the University of Newcastle in Australia, lead author of the study, explains that, “The bundle is about a range of important initiatives needed to improve hospital cleaning. They can be applied in any scenario regarding of the pathogen of concern.” Mitchell adds, “Cleaning is a complex activity and our study showed that range of things need to be applied to improve cleanliness and reduce infection rates. Education and training alone, for example, has been shown in some studies to have benefit, but it is not necessarily sustained.”
Education of healthcare workers was an essential component of the bundle. As the researchers emphasized, “Core training content included cleaning roles and responsibilities, components of the cleaning bundle, and effect of environmental cleaning on healthcare-associated infections. The cleaning technique included a de fined and consistent cleaning sequence, daily cleaning of the high-risk frequent touch points, use of sufficient pressure and movement, and adherence to manufacturers’ instructions for product use (dilutions and contact time). Tailored training activities and content reflected the context of the respective hospitals, including existing cleaning products and schedules. Communication was a key strategy to sustaining a hospital-wide commitment to improved cleaning and bundle components. Hospital-wide promotional activities were used to raise the profile and importance of cleaning in reducing infections and to support a culture shift in environmental services staff. Daily contact between cleaning staff and ward leaders or managers was encouraged, with cleaning staff representation on relevant clinical governance committees.”
The researchers used several strategies to monitor cleaning bundle implementation, infection prevention, and control program changes and outbreaks or other issues at each hospital during the trial period. A key strategy was regular email and telephone contact, at least monthly, between the study and site team. The study team also requested that a monitoring document be completed by the site team every two months to systematically capture changes in any aspect of the infection prevention program, including screening and staffing changes, outbreaks, and the fidelity of the bundle implementation.
The primary outcomes were incidence rates of HAIs: Staphylococcus aureus bacteremia (methicillin-resistant and methicillin-sensitive), Clostridium difficile infection, and vancomycin-resistant enterococci infections (sterile sites only), at each hospital, per 10,000 occupied-bed days, and the cost-effectiveness of a decision to adopt the environmental cleaning bundle. The cost-effectiveness outcome will be reported separately. For the calculation of health-care-associated infections, preintervention data refers to combined data from the historical, establishment, and control phases and first four weeks of implementation. Post-intervention data were collected from four weeks after the start of intervention to allow for a delay in the intervention effect. Standardized infection definitions were applied.
The secondary outcome was thoroughness of hospital cleaning, measured by the DAZO Fluorescent Marking Gel and Ultraviolet Light System. Data collection of cleaning audits occurred during the control and intervention period. The outcome was the probability that a dot was completely removed.
During the study, 25,443 individual frequent touch points (5,134 control, 20,309 intervention) were audited; 690 of available beds were audited every quarter. The proportion of frequent touch points cleaned increased in both the bathroom and patient room. The percentages of frequent touch points cleaned before and after the intervention increased from 55 percent to 76 percent for the patient room, and from 64 percent to 86 percent for the bathroom. No changes in hand hygiene compliance or antimicrobial use were seen over the course of the trial; however, there was large variation in antimicrobial use between difference classes.
The researchers report that implementation of the REACH cleaning bundle resulted in improved thoroughness of cleaning that continued to improve over the intervention period. The thoroughness of cleaning at baseline (control) was low. As the researchers note, “We would expect variation in cleaning practices to also be present in hospitals excluded from our study. Our results are similar to previous findings demonstrating the benefit of using a fluorescent gel to assess cleaning with provision of feedback to staff; however, our intervention included other elements, such as a focus on cleaning technique, training, communication, and correct product use. Using this bundled intervention, we previously reported changes in knowledge, practice, and attitudes in environmental services staff, improvement in the thoroughness of cleaning, and an overall reduction in healthcare-associated infections.”
Mitchell emphasizes that, “There is no one element of the bundle that is more important. To improve thoroughness of cleaning, you need tailored education and feedback of cleaning outcomes to cleaning staff, as well as appropriate products and communication.”
By contrast with previous research, Mitchell, et al. (2019)’s bundle development process prioritized evidence-based strategies that were easier to implement and lower cost than newer expensive technologies. An economic evaluation of the REACH trial also conducted by the researchers assessed cost-effectiveness to inform whether the REACH bundle should be adopted under conditions of scarce resources.
Mitchell says it is hoped that use of this bundle correlates to decreased infection rates. “Of course, cleaning is just one very important component of an infection control program or strategy to reduce the risk of infections,” he says. “Improving cleaning alone will aid a reduction in infection rates, but other measures such as improving hand hygiene and correct insertion and maintenance of medical devices are some other very important measures. What we have shown, using the highest quality research to date, it that it is possible to improve cleaning and when you do, it can assist in reducing infection rates. Our study is a reminder that investment in cleaning and cleaning staff is a critical element of patient safety in hospitals and that investment in cleaning (the bundle we tested) is cost-effective.
Han JH, Sullivan N, Leas BF, Pegues DA, Kaczmarek JL and Umscheid CA. Cleaning Hospital Room Surfaces to Prevent Health Care–Associated Infections. Ann Intern Med. 2015 Oct 20; 163(8): 598–607. https://annals.org/aim/fullarticle/2424875/cleaning-hospital-room-surfaces-prevent-health-care-associated-infections-technical
Mitchell BG, Hall L, White N, Barnett AG, Halton K, Paterson DL, Riley TV, Gardner A, Page K, Farrington A, Gericke CA and Graves N. An environmental cleaning bundle and health-care-associated infections in hospitals (REACH): a multi-center, randomized trial. Lancet Infect Dis. 19: 410-18. 2019.
Palmore TN and Henderson DK. Editorial: Intensifying the Focus on the Contribution of the Inanimate Environment to Healthcare-Associated Infections. Ann Intern Med. Oct. 20, 2015