Elaine L. Larson

Effect of Antibacterial Home Cleaning and Handwashing Products on Infectious Disease Symptoms: A Randomized, Double-Blind Trial

Context Household cleaning products containing antibacterial ingredients are widely available and popular. Although manufacturers use claims of health benefits to market these products, evidence linking the use of antibacterial products to health outcomes has been lacking. Contribution This innovative trial found no difference in episodes of infectious disease symptoms over one year in 228 inner-city households randomly assigned to use antibacterial household cleaning products or identically packaged products without antibacterial ingredients. Implications These findings highlight the need to better educate consumers about the use and limitations of household antibacterial cleaning products. The Editors Changing demographic and social patterns, such as more working parents, increased numbers of meals eaten in restaurants, and more child-care outside of the home, are causing concomitant changes in patterns of infectious diseases (1). For example, recent foodborne outbreaks have resulted from widespread distribution of contaminated foods, such as meat or ice cream. Media attention to such outbreaks and the resultant public concern about disease transmission may be one reason for the burgeoning of various products that are labeled antibacterial and that are readily available for personal hygiene and general cleaning. These demographic and social shifts raise the question of the relative importance of home hygienic practices in the prevention of infectious diseases. The home environment has been implicated as one important source of spread of infectious diseases (2-4), and hygienic interventions have resulted in reduced incidence, particularly in less-developed countries (5). In the United States, several studies have demonstrated the effectiveness of hygienic interventions in reducing transmission of infections in child-care centers and schools (6-9). However, despite the fact that 75% of liquid and 29% of bar soaps available in the U.S. consumer market contain antibacterial ingredients (10), their benefits in terms of reducing the incidence of infectious diseases in households have not been demonstrated. In addition, concerns have been raised about the potential for long-term use of such products to increase resistance to antiseptics or cross-resistance with antibiotics (11, 12). Therefore, we sought to evaluate the effect of antibacterial cleaning and handwashing products on the occurrence of infectious disease symptoms in households. Methods In this double-blind clinical trial, we randomly assigned households to one of 2 intervention groups: those who used handwashing and household cleaning products with antibacterial ingredients and those who used products without such ingredients. The interventions lasted for 48 weeks. Sample and Setting We conducted the study in an inner-city neighborhood in northern Manhattan, New York, with a predominantly immigrant population in multigenerational households. Almost 30% of residents spoke little or no English, and about 90% of the households had telephones (13). To qualify for the study, a household unit had to include 3 or more persons with at least one preschool-age child and had to have access to a telephone. In addition, household members had to speak English or Spanish. In a preliminary survey (14) conducted in this neighborhood, 78.5% of 398 households reported infectious disease symptoms within the previous month, and in 37.9% of these households, at least one person sought medical attention and received specific treatment or antibiotics for an infectious disease symptom or symptoms. On the basis of this pilot work, we concluded that a randomized clinical trial with sufficient statistical power was feasible. Recruitment was by word of mouth, referral, and English- and Spanish-language flyers (preapproved by the institutional review board) posted throughout the community. Participants were recruited by an experienced, trained interviewer who resided in the community and who was a native Spanish speaker. We determined sample size by power analysis. With 100 households for each intervention group and a household incidence of infectious disease symptoms of about 35% per month, on the basis of the pilot study, it would be possible to detect an absolute difference between the 2 intervention groups of 20 percentage points or more (for example, from 35% to 15%) with a power of 80% and an value of less than 0.05 (15). We recruited an additional 19% above this desired sample size to account for potential loss to follow-up and dropouts. A total of 238 households were randomly assigned, and 224 (94.1%) completed the entire 48 weeks of data collection. Fourteen households (5.9%) did not complete the entire study period, 9 (64.3%) because the household moved out of the study area, 3 (21.4%) because the household did not continue to use the products, and 2 (14.3%) because the household was inadvertently supplied with the wrong product (Figure 1). Figure 1. Profile of randomized, clinical trial. Intervention Criteria for selecting products to be tested were as follows: The products had to be readily available over the counter; have the same or similar formulation, except for the presence or absence of an antibacterial ingredient; be representative of a particular category of product so that results could be generalized to other similar products; and be developed by reputable companies known for good manufacturing practices. Antibacterial was defined as the presence of triclosan, quaternary ammonium compounds, hypochlorite, or another recognized microbicidal agent in amounts greater than preservative levels. Also, the product label had to include the term antibacterial or disinfectant. Households randomly assigned to the antibacterial group were provided with the following: a liquid kitchen spray and all-purpose hard-surface cleaner containing a quaternary ammonium compound, liquid handwashing soap containing triclosan, and a laundry detergent containing oxygenated bleach. The nonantibacterial group received parallel products with similar compositions that did not contain antibacterial ingredients. Both intervention groups were provided with the same liquid dishwashing detergent and bar soap, neither of which contained antibacterial ingredients. Procedures The study was approved by the Columbia Presbyterian Medical Center Institutional Review Board. After we obtained written informed consent, households were randomly assigned to one of the intervention groups; the master key code was retained by the biostatistician. All products were provided without cost, were packaged identically with a generic label indicating their use, and were delivered to the household monthly. On the initial home visit, we collected baseline data on home hygiene practices and the presence of infectious disease symptoms within the previous month for each household member by using our Home Hygiene Assessment Form. We made a weekly telephone call and a monthly home visit to each household. During the monthly visit, we assessed adherence to the product regimens by weighing the remainder of products with a postal scale and inspecting the home for the presence of other products. Every 3 months, we assessed symptoms in individual household members, and the Home Hygiene Assessment Form was readministered to determine whether any hygienic practices had changed. We conducted an average of 226 interviews each week. For most of the households (98.8%), at least 20 weekly interviews were completed, and for 89.0% of households, 45 or more weekly interviews were completed. Data were collected by 3 interviewers who received extensive training using a written orientation manual, practice sessions with return demonstrations, and inter-rater reliability assessments. The interviewers and project director were native Spanish speakers; 3 were physicians, and the fourth was a trained community health worker. Initially and on a random monthly basis, each interviewer was accompanied by the project director on 10% of the home visits for ongoing quality control. Instrument Because cleaning and hygiene practices within the home would probably affect the dependent variable, infectious disease symptoms, we collected extensive data on cleaning and hygiene practices at baseline and at quarterly intervals. The Home Hygiene Assessment Form is a 31-page interview booklet that includes questions about demographic characteristics and illness (age, sex, ethnicity, country of birth, hours per week spent outside the home, type of work for adults, school or child-care arrangements for children, state of health, and presence of chronic diseases), home hygiene practices (54 items), and other relevant household factors (numbers and ages of household members, size of living space, presence of pets and visitors, type of building, and heating and cooling systems). We also asked participants about their attitudes and beliefs about how germs are spread and what they did to prevent infections in their home. The components of the instrument were originally derived from a literature search, focus groups of consumers, and a panel of environmental sanitation experts. The Home Hygiene Assessment Form was tested extensively for validity and reliability (16). Whenever possible, direct observations were made to confirm self-reports. Measurement of Dependent Variable (Infectious Disease Symptoms) The presence of infections was assessed symptomatically. We instructed participants to call their interviewer if any member of the household had vomiting, diarrhea, fever, sore throat, cough, runny nose, skin infection, or conjunctivitis (pinkeye). We provided each household with a supply of single-use thermometers (Tempa-DOT, 3M Health Care, St. Paul, Minnesota) and gave instructions for their use. In the weekly telephone call from the interviewer, we also solicited information on symptoms. If participants reported a cough, they were queried by a physician about whether i

Health care–associated infection outbreaks in pediatric long-term care facilities

n n Children in pediatric long-term care facilities (pLTCFs) have complex medical conditions and increased risk for health care–associated infections (HAIs). We performed a retrospective study from January 2010-December 2013 at 3 pLTCFs to describe HAI outbreaks and associated infection control interventions. There were 62 outbreaks involving 700 cases in residents and 250 cases in staff. The most common interventions were isolation precautions and education and in-services. Further research should examine interventions to limit transmission of infections in pLTCFs.n n

Infection prevention and control practices in pediatric long-term care facilities

Pediatric long-term care facilities (pLTCFs) provide for children with chronic, complex medical needs and therefore face unique challenges for infection prevention and control (IP&C). At a conference in 2012, pLTCF providers reported IP&C issues of greatest concern in a survey. Major concerns included the lack of IP&C best practice guidelines, multidrug-resistant bacteria, and viral respiratory infections. Best practice guidelines for IP&C specific to pLTCF populations should be developed and evaluated.

Challenges in Conducting Research in Pediatric Long-Term Care Facilities

Background. Children residing in long-term care facilities (LTCFs) have complex medical problems and unique care needs, yet research in this setting is rare. As part of an intervention study to improve patient safety (Keep It Clean for Kids [KICK]), we describe the challenges encountered and recommend approaches to build a successful and sustained collaborative relationship between pediatric LTCFs and the research team. Methods. We implemented a program with 5 components: leadership commitment, active staff participation by the creation of KICK teams, workflow assessments, staff training in the World Health Organization’s “5 Moments for Hand Hygiene,” and electronic monitoring and feedback to staff regarding hand hygiene practices. Results. Major challenges encountered were establishing trust, building research teams, enhancing staff participation, and engaging families and visitors. Approaches to deal with these challenges are discussed. Conclusions. Conducting research in pediatric LTCFs requires sustained commitment to dealing with challenges and establishing collaborative relationships with administrative and frontline staff.

Assessing Nursing Care Needs of Children With Complex Medical Conditions: The Nursing-Kids Intensity of Care Survey (N-KICS).

UNLABELLEDnRecent medical advances have resulted in increased survival of children with complex medical conditions (CMC), but there are no validated methods to measure their care needs.nnnOBJECTIVES/METHODSnTo design and test the Nursing-Kids Intensity of Care Survey (N-KICS) tool and describe intensity of nursing care for children with CMC.nnnRESULTSnThe psychometric evaluation confirmed an acceptable standard for reliability and validity and feasibility. Intensity scores were highest for nursing care related to infection control, medication administration, nutrition, diaper changes, hygiene, neurological and respiratory support, and standing program.nnnCONCLUSIONSnDevelopment of a psychometrically sound measure of nursing intensity will help evaluate and plan nursing care for children with CMC.

Hand-hygiene practices and observed barriers in pediatric long-term care facilities in the New York metropolitan area

OBJECTIVEnTo describe hand-hygiene practices in pediatric long-term care (pLTC) facilities and to identify observed barriers to, and potential solutions for, improved infection prevention.nnnDESIGNnObservational study using (i) the World Health Organizations 5 Moments for Hand Hygiene validated observation tool to record indications for hand hygiene and adherence; and (ii) individual logs of subjective impressions of behavioral and/or systemic barriers witnessed during direct observation.nnnSETTINGnStaff in three pLTC facilities (284 beds total) were observed by two trained nurses 1 day a week for 3 weeks in February and March 2015.nnnPARTICIPANTSnDirect providers of health, therapeutic and rehabilitative care, and other staff responsible for social and academic activities for children with complex, chronic medical conditions.nnnMAIN OUTCOME MEASURESnHand-hygiene indications, adherence and barriers.nnnRESULTSnHand hygiene was performed for 40% of the 847 indications observed and recorded. Adherence increased at one site and decreased in the other two sites during the study period. Adherence appeared to be influenced by individuals knowledge, attitudes, beliefs and work setting.nnnCONCLUSIONSnPoor hand-hygiene adherence was observed overall. Specific barriers were identified, which suggest a contextual approach to the interpretation of results indicated in this uniquely challenging setting. We offer some practical suggestions for overcoming those barriers or mitigating their effect. Ultimately, an adaptation of the 5 Moments for Hand Hygiene may be necessary to improve infection prevention in pLTC.

Developing Case Definitions for Health Care–Associated Infections for Pediatric Long-Term Care Facilities

Health care–associated infections (HAIs) are a leading cause of morbidity, hospitalizations in acute care, mortality, and increased health care costs among residents of long-term care facilities (LTCFs). Children residing in pediatric LTCFs (pLTCFs) have chronic medical conditions, which may increase their risk for HAIs. In addition, group activities are used daily in pLTCF for rehabilitation, socialization, and education, involving a large interdisciplinary care team and volunteers. These unique features of pLTCFs coupled with residents’ young age and vulnerability to infection can facilitate transmission and lead to outbreaks. Standardized surveillance case definitions are an integral part of infection prevention and control for HAI. In 1991, McGeer et al published HAI surveillance case definitions for LTCFs providing care to elderly residents. In 2012, the Society for Healthcare Epidemiology of America (SHEA) and the Centers for Disease Control and Prevention (CDC) published updated HAI surveillance definitions for adults in LTCFs, but noted that definitions should be created for the pLTCF population. We performed a pilot study to assess the utility of the SHEA/CDC surveillance case definitions for children in pLTCFs.

Staff Knowledge, Awareness, Perceptions, and Beliefs About Infection Prevention in Pediatric Long-term Care Facilities.

BackgroundThe burden of healthcare-associated infection worldwide is considerable, and there is a need to improve surveillance and infection control practices such as hand hygiene. ObjectivesThe aims of this study were to explore direct care providers’ knowledge about infection prevention and hand hygiene, their attitudes regarding their own and others’ hand hygiene practices, and their ideas and advice for improving infection prevention efforts. MethodsThis exploratory study included interviews with direct care providers in three pediatric long-term care facilities. Two trained nurse interviewers conducted semistructured interviews using an interview guide with open-ended questions. Two other nurse researchers independently transcribed the audio recordings and conducted a thematic analysis using a strategy adapted from the systematic text condensation approach. ResultsFrom 31 interviews, four major thematic categories with subthemes emerged from the analysis: (a) hand hygiene products; (b) knowledge, awareness, perceptions, and beliefs; (c) barriers to infection prevention practices; and (d) suggested improvements. There was confusion regarding hand hygiene recommendations, use of soap or sanitizer, and isolation precaution policies. There was a robust “us” and “them” mentality between professionals. DiscussionOne essential driver of staff behavior change is having expectations that are meaningful to staff, and many staff members stated that they wanted more in-person staff meetings with education and hands-on, practical advice. Workflow patterns and/or the physical environment need to be carefully evaluated to identify systems and methods to minimize cross-contamination. Further studies need to evaluate if personal sized containers of hand sanitizer (e.g., for the pocket, attached to a belt or lanyard) would facilitate improvement of hand hygiene in these facilities.

Direct Costs of Acute Respiratory Infections in a Pediatric Long Term Care Facility

Acute respiratory tract infections (ARI) are a major burden in pediatric long‐term care. We analyzed the financial impact of ARI in 2012–2013. Costs associated with ARI during the respiratory viral season were ten times greater than during the non‐respiratory viral season,

Using Workflow Diagrams to Address Hand Hygiene in Pediatric Long-Term Care Facilities

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