The Impact of Bedside Wipes in Multi-patient Rooms: a Prospective, Crossover Trial Evaluating Infections and Survival

Study Overview
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Brief Summary
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Multidrug resistant organisms (MDRO) are prevalent in hospitals and are associated with hospital-acquired infections (HAI). High-touch surfaces serve as reservoirs and fomites for MDRO transmission. The investigators quantified the impact of hanging single-use cleaning/disinfecting wipes in patients' immediate environment within multi-patient rooms. Pre-specified outcomes were: 1) HAI rate, 2) cleaning frequency, 3) MDRO room contamination, 4) new MDRO acquisitions, and 5) in-hospital mortality.

Detailed Description
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The study will be conducted over 15 months; each study phase will last 6 months, with a pre-study period (1 month), a washout period (1 month) and a post study period (1 month). Pre-study period: all rooms will be cleaned daily according to common practice which consists of using hypochlorite in a concentration of 1000 ppm (bleach) and reused cloths. The immediate environment (i.e., the 'patient's unit') of those with C. difficile carriage will be cleaned daily with hypochlorite 2000 ppm and upon discharge with hypochlorite 5000 ppm. This is the current common practice at AHMC. Phase I: medicine A and B: high touch surfaces (e.g., bedrail, bedside tables, monitor, and cables) will be cleaned with Clinell® Universal Wipes, and the patient's unit of C. difficile carriers will be cleaned with Clinell® Sporicidal Wipes. The floor, walls, and sink, will still be cleaned with bleach. Medicine C and D: all rooms will be cleaned daily according to common practice as mentioned above. Washout period in all Medicine departments A, B, C and D: all rooms will be cleaned daily according to common practice as mentioned above. Phase II: medicine A and B: all rooms will be cleaned daily according to common practice as mentioned above. Medicine C and D: high touch surfaces (bedrail, bedside tables, monitor, cables) will be cleaned with Clinell® Universal Wipes, and the patient's unit of C. difficile carriers will be cleaned with Clinell® Sporicidal Wipes. The floor, walls, and sink, will still be cleaned with bleach. Post-study period: all rooms will be cleaned daily according to common practice as mentioned above. During the intervention phase, the whole department will be subjected to the intervention, regardless of the number of MDRO carriers present on the department (i.e. signifying the colonization pressure at the department). Colonization pressure will be continuously captured and recorded for future analyses. All departments will perform, per local Infection Control regulations, rectal surveillance cultures upon admission to the department, to diagnose VRE, CRE-CP, and CRE-non-CP from certain populations: 1) patients directly transferred from another hospital; 2) patients directly transferred from another department inside AHMC; 3) functionally dependent patients (per Katz criteria); 4) residents of long-term care facilities; 5) patients who were hospitalized in an acute care hospital in the past six months; and 6) prisoners. In addition, every department selects one day per week for screening (rectally again) of 10 additional patients who are already hospitalized, but belong to high risk population for VRE and/or CRE colonization. In addition, once a week, a sputum screening culture for the presence of A. baumannii is obtained from all mechanically ventilated patients. No other surveillance cultures are performed in those Medicine departments, except theoretically as part of an outbreak investigation. The median departmental occupancy of all participating departments is 45 patients (the median number of mechanically ventilated patients in each department is 5). The patients' mix in all participating departments is equal, and patients are hospitalized in a certain department randomly. The departments are equal in structure, in the number of patients, and in its patients' characteristics. All the surveillance for HAI determination and MDRO acquisitions are conducted routinely and continuously by the Infection Control team at AHMC. The primary investigator of this proposal serves as the head of Infection Control service and therefore is personally involved in the surveillances processes for those endpoints. Frequency of cleaning will be assessed by Clinell® EvaluClean™ fluorescent marker system twice a week, on Mondays and Thursdays morning until afternoon, in all participating departments throughout the study period. The assessment will include the marking of five locations at a patient unit from each participating department, and the examination of the marks 4 hours later. The five location points are: 1) right bedrail, 2) the tray of the bedside table, 3) the binder that contains the fluid balance pages, hanging at the foot of the bed, 4) Strip for delivery and storage at the headboard of each bed, and 5) the bed itself. Since the 4 study units are all identical in structure (in terms of room numbers and bed numbers), the patient units that will be randomly selected every week will be compatible. For example, in the first week, the patient units that could be randomly selected will be bed number 2 in room number 9 and bed number 1 in room number 2, in all 4-study units. Clinical cultures are all processed at the AHMC clinical microbiology laboratory. No additional cultures will be obtained specifically for this protocol. MRSA, VRE, A. baumannii, and P. aeruginosa will be determined according to a Vitek-2 automated system and according to CLSI breakpoints and criteria. CRE-CP and CRE non-CP will be determined according to the Israeli MOH national diagnostic guidelines (2013) and based, again, on CLSI criteria. Toxin-producing C. difficile will be determined based of a GDH-based serology test (C. DIFF QUIK CHEK COMPLETE®; Alere™) and if necessary (i.e., inconclusive serology test result: positive for C. difficile GDH antigen but negative for C. difficile toxins), will be confirmed by a PCR-based test (Xpert® C. difficile; Cepheid©). Samples will be processed according to national Israeli guidelines (2013) and according to CLSI criteria. All MDROs will be stored in -700C for future molecular analyses Representative MDROs will be typed later on for future detailed transmission dynamics investigations. The laboratory will be blinded to the source of the cultures (i.e., the study department and study phase).

Official Title
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The Use of Clinell Universal Wipes, Clinell Sporicidal Wipes, and Clinell EvaluClean Fluorescent Marker System, in Reducing Environmental Contamination and Acquisitions of Multidrug Resistant Organisms and Hospital Acquired Infections

Conditions
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Hospital Acquired Infection

Intervention / Treatment
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* Other: Single-use wipes installed at the bedside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized at one of four Medicine departments at Assaf Harofeh Medical Center: Medicine A, Medicine B, Medicine C, or Medicine D. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: We conducted a clustered crossover trial at Shamir medical center from October 20, 2016 to January 19, 2018. Clusters were randomly assigned to use either single-use quaternary ammonium-based wipes (Clinell®; Watford, UK) or standard practices (reusable cloths, buckets and bleach (hypochlorite 1,000-5,000 ppm)) for cleaning of high-touch surfaces. Six-month intervention periods were implemented in alternating sequence, separated by a 4-week washout period. Five high-touch surfaces were monitored by fluorescent markers (EvaluClean®; Watford, UK), and for the presence of MDRO. Study outcomes were compared between periods using generalized estimating equations, Poisson regression and Cox proportional hazards models.


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention phase<br>Single-use wipes installed at the bedside | Other: Single-use wipes installed at the bedside<br> <br> |
| No Intervention: Non-intervention phase<br>Standard practice according to Israeli ministry of health (MOH) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related HAI rates | Central line associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI), monitored in accordance to CDC criteria | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cleaning | Invisible fluorescent marks at the patient unit will be examined to assess whether the location has been cleaned or not, using Clinell® EvaluClean™ fluorescent marker system. The endpoint would be presented as percents of adherence (i.e., the number of locations cleaned, divided by the overall number of locations what were marked). | 12 months | 
| MDRO environmental contamination | Environmental contamination measurements of MDRO were performed for all patients with a current or recent (prior two years) culture of MRSA, VRE, CRE, A. baumannii, or P. aeruginosa. | 12 months | 
| New MDRO acquisitions | MDRO included methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), carbapenemase-producing and non-carbapenemase-producing carbapenem-resistant Enterobacterales (CRE-CP and CRE-non-CP, respectively), and non-lactose fermenting Gram-negative bacilli (Acinetobacter baumannii, Pseudomonas aeruginosa) | 12 months | 
| In-hospital mortality | In-hospital mortality was collected from medical charts. The endpoint is defined as the proportion of patients with in-hospital deaths during the measurement period. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital Environment, MDRO, Multidrug resistant, Nosocomial infections, Cleaning Practices, High-touch surfaces, HAI