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临床试验/NCT05973916
NCT05973916招募中不适用

A Comprehensive Intervention to Improve the Level of Cleaning and Disinfection of Patients' Units, in Order to Reduce New Acquisitions and Environmental Contamination by Multidrug Resistant Organisms: a Prospective Controlled Crossover Trial, Using VYV Led Lights and Continuous Air Filtering of Patients' Rooms, Coupled With Establishment of a "Patient's Unit Commando" Cleaning Team.

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2023年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,400
试验地点
2
主要终点
Acquisitions of pre-specified MDROs:

研究概览

简要总结

A comprehensive intervention to improve the level of cleaning and disinfection of patients' units, in order to reduce new acquisitions and environmental contamination by multidrug resistant organisms: a prospective controlled crossover trial, using VYV led lights and continuous air filtering of patients' rooms, coupled with establishment of a "patient's unit commando" cleaning team.

详细描述

Background and introduction

As declared by the World Health Organization (WHO) in 2016, antimicrobial resistance among the commonest human pathogens, i.e., the multidrug resistant organisms (MDRO), pose one of the biggest challenges in modern Medicine and one of the biggest threats to humanity. MDROs are prevalent in acute-care hospitals, and in addition are continuously emerging at non-acute-care healthcare settings, and even in the community. The current global SARS-CoV-2 pandemic, further amplifies the enormous burdens imposed by MDROs on hospitalized previously non-sick individuals. The commonest Gram-positive MDROs are methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and Clostridioides difficile (C. diff). The commonest Gram-negative MDROs are carbapenem-resistant and/or carbapenemase-producing Enterobacterales (CRE), Acinetobacter baumannii (CRAB), and Pseudomonas aeruginosa (CRPA). Acquisition of an MDRO in the hospital is associated with devastating outcomes to the individual patient and with enormous fiscal burden imposed on health facilities. Moreover, In Israel and in many other countries, there are mandatory reporting regulations for certain MDROs, and the rates of MDRO acquisitions serve as "pay per performance" initiatives. This adds additional burden in terms of potential bad reputation and reductions in reimbursements.

The patient's immediate environment, specifically "high-touch surfaces" (e.g., touch screens, monitor, respirator, feeding device, infusion pump, the entire bed, cabin, nurse's call-on button, light switches, fluid balance charts hanged on bed, linen, armchairs, curtains, and so on), serves as reservoir and vector for MDRO distribution and transmission from patient to patient. Therefore, health facilities have strong motivation to improve the level of cleaning and disinfection of patients' immediate environment, in an effort to improve patient safety, quality of clinical care, and reduce hospital costs while improving its reputation.

Many items commonly used in traditional and routine care of hospitalized patients, have been described as reservoirs and/or fomites for transmission of pathogens, which can lead to nosocomial MDRO-related outbreaks. Environmental remnants of MDROs on immediate high touch surfaces spread from patient to patient through staff, shared equipment, or directly from patient to patient (less common). While a carrier of a specific MDRO reside in his/her room or unit, the same MDRO can be isolated (frequently in high inoculums) from the patient's immediate environment (e.g. bedrail, monitor, infusion pump), from high-touch surfaces (e.g., light switches, water taps, nurse's call-on button), and even from distant locations in the room (e.g. ceiling). MDROs can remain viable and survive in those transmitting-prone environmental locations for prolonged periods, long after the previous carrier who contaminated the environment had been discharged.

The levels of environmental cleaning and disinfection of high-touch surfaces, is known to be low in hospitals. The current cleaning guidelines at Shamir Medical Center (SMC), as per the Israeli MOH regulations, are as follows: while the patient is in their bed, the unit is subjected to daily cleaning, and after the patient leaves, the unit is subjected to "terminal cleaning", a supposable standardized enhanced cleaning protocol. Recurrent audits and observations from all over the world clearly suggests that the level of cleaning and disinfection of patients' environments in acute-care hospitals is unsatisfactory most hours of the day. In order to improve this crucial aspect associated with MDRO transmission and spread in hospitals, a multidisciplinary approach is warranted, with implementation of novel solutions both technological, and with regards to aspects associated with human capital. To add an additional complexity to the situation, in Israeli hospitals, as in many other countries, the responsibility of cleaning/disinfecting patient's immediate environment, is divided. The bed, bedside table, infusion pump, monitor, cables and additional immediate surroundings of an individual patient, are cleaned by nurse assistants, while the floor, sink, toilets, light switches and walls (shared by all room occupants), are cleaned by environmental services (EVS) personnel. This separation in responsibilities creates eventual gaps in the overall level of cleaning/disinfection of certain items, which are frequently associated with MDRO transmission. There are continuous shortages both in terms of full time effort (fte) allocation, and in terms of specified professional training, among these two frequently neglected sectors (i.e., nurse assistants and EVS personnel). The employment turnaround time of these personnel sectors is very high, with no establishment of a stable local base of knowledge and expertise. In order for an intervention that improves the level of cleaning /disinfection of patients' environment to be successful, human capital considerations must be acknowledged and addressed. A designated team (referred to as "cleaning commando" in certain facilities), responsible to all the various aspects associated with cleaning and disinfecting the patient's environment, but have no other additional responsibilities, and is managed by the same management, could theoretically improve the human capital aspects associated with improving the level of cleaning/disinfecting patients' environments in hospitals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized at Medicine A or Medicine B, Shamir (Assaf Harofeh) Medical Center.

排除标准

  • 未提供

结局指标

主要结局

Acquisitions of pre-specified MDROs:

时间窗: 6 months

Incidence of MDRO new carriage acquisitions (per 1,000 patient-days).

次要结局

  • Acquisitions of hospital acquired bloodstream infection(6 months)
  • Acquisitions of ospital acquired urinary-tract infection (HAUTI) incidence (per 1,000 patient-days).(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dror MarChaim, MD

Head of the Unit of Infection Control & Prevention

Assaf-Harofeh Medical Center

研究点 (2)

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