Clinical trial NCT01579370: Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)
Official title: A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multidrug Resistant Organisms
Healthcare Associated Infections
Keywords: healthcare associated infections
multidrug resistant organisms
methicillin resistant staphylococcus aureus
vancomycin resistant enterococcus
clostridium difficile
acinetobacter
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 21395
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

Detailed description: Meticulous and consistent use of hand hygiene before and after patient care remains the cornerstone of infection prevention in all health care settings. However, clean hands are not sufficient to prevent all healthcare-associated infections (HAIs), as 1) hands of healthcare workers easily become contaminated from contact with contaminated environmental surfaces in patient rooms after appropriate hand hygiene has been performed and before direct patient care and 2) direct contact by patients with preexisting contaminated environmental surfaces in their hospital rooms can lead to colonization or infection. Thus, novel strategies are needed to prevent HAIs, particularly those caused by multidrug-resistant (MDR) pathogens that persist in the environment such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), Clostridium difficile, and Acinetobacter.

Enhanced environmental disinfection methods may lead to reduced risk of exposure to or acquisition of HAIs and MDR-pathogens and overcome a critical issue facing healthcare today - hospitals rooms are often poorly cleaned and disinfected. Enhanced terminal room disinfection strategies using bleach and/or UV-C emitting devices have been investigated only in experimental conditions; the efficacy, effectiveness, and feasibility of enhanced terminal room disinfection to prevent HAIs are unknown. Thus, the scientific evidence for such interventions currently is insufficient for their inclusion in evidence-based guidelines.

This study will investigate the hypothesis that enhanced terminal room disinfection protocols (using chlorine-based cleaning agents with or without UV-C light-emitting devices) will decrease the overall risk of HAIs in the hospital and, more specifically, in subsequent patients who are cared for in the same room. This prospective investigation will employ a crossover design utilizing four room cleaning/disinfection protocols in 9 hospitals, including 2 tertiary care, 1 VA, and 6 community hospitals. Phase T2 data from this study will be useful in assessing the clinical efficacy and feasibility of individual disinfection strategies. Thus, the goals of the investigators proposed research are to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

Eligibility criteria: Inclusion Criteria:

* Any seed room (ie., room from which a patient with one of the target organisms has been transferred or discharged)

Exclusion Criteria:

* None, intervention is at level of the room, not the patient
* Patient outcomes will be excluded if clinical cultures are obtained within 48 hours of admission to the room of interest.

Primary outcomes:
measure: Clinical incidence rate of four target organisms among patients admitted to a study room
timeFrame: 90 days
measure: Clinical incidence rate of C. difficile among patients admitted to a study room
timeFrame: 28 days
Secondary outcomes:
measure: Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room.
timeFrame: 90 days
measure: Clinical incidence rate of target organisms among all patients admitted to the hospital
timeFrame: 90 days
measure: Clinical incidence rate of MRSA among all patients admitted to the hospital
timeFrame: 90 days
measure: Clinical incidence rate of VRE among all patients admitted to the hospital
timeFrame: 90 days
measure: Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital
timeFrame: 90 days
measure: Clinical incidence rate of C. difficile among all patients admitted to the hospital
timeFrame: 28 days
measure: Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients.
timeFrame: Patients will be followed an average of 30 days
measure: Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients.
timeFrame: Patients will be followed an average of 30 days
measure: Missed Opportunities
timeFrame: each study period (6 months)
measure: Time on Diversion
timeFrame: Each study period (6 months)
measure: Room Turnover Time
timeFrame: Each study period (6 months)
measure: ED to floor wait time
timeFrame: Each study period (6 months)
measure: Clinical incidence of MRSA, VRE, C. difficile, and MDR-Acinetobacter during UV-C light versus No UV-C light
timeFrame: 12 months (2 6-month study arms combined)
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Health System
state: North Carolina
city: Raleigh
country: United States
facility: Rex Healthcare
state: North Carolina
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
city: Chesapeake
country: United States
facility: Chesapeake Regional Medical Center
state: Virginia
Study officials:
affiliation: Duke University
name: Daniel J Sexton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rutala WA, Kanamori H, Gergen MF, Knelson LP, Sickbert-Bennett EE, Chen LF, Anderson DJ, Sexton DJ, Weber DJ; and the CDC Prevention Epicenters Program. Enhanced disinfection leads to reduction of microbial contamination and a decrease in patient colonization and infection. Infect Control Hosp Epidemiol. 2018 Sep;39(9):1118-1121. doi: 10.1017/ice.2018.165. Epub 2018 Jul 31.
citation: Anderson DJ, Moehring RW, Weber DJ, Lewis SS, Chen LF, Schwab JC, Becherer P, Blocker M, Triplett PF, Knelson LP, Lokhnygina Y, Rutala WA, Sexton DJ; CDC Prevention Epicenters Program. Effectiveness of targeted enhanced terminal room disinfection on hospital-wide acquisition and infection with multidrug-resistant organisms and Clostridium difficile: a secondary analysis of a multicentre cluster randomised controlled trial with crossover design (BETR Disinfection). Lancet Infect Dis. 2018 Aug;18(8):845-853. doi: 10.1016/S1473-3099(18)30278-0. Epub 2018 Jun 4.
citation: Anderson DJ, Knelson LP, Moehring RW, Lewis SS, Weber DJ, Chen LF, Triplett PF, Blocker M, Cooney RM, Schwab JC, Lokhnygina Y, Rutala WA, Sexton DJ; CDC Prevention Epicenters Program. Implementation Lessons Learned From the Benefits of Enhanced Terminal Room (BETR) Disinfection Study: Process and Perceptions of Enhanced Disinfection with Ultraviolet Disinfection Devices. Infect Control Hosp Epidemiol. 2018 Feb;39(2):157-163. doi: 10.1017/ice.2017.268. Epub 2018 Jan 14.
citation: Anderson DJ, Chen LF, Weber DJ, Moehring RW, Lewis SS, Triplett PF, Blocker M, Becherer P, Schwab JC, Knelson LP, Lokhnygina Y, Rutala WA, Kanamori H, Gergen MF, Sexton DJ; CDC Prevention Epicenters Program. Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study. Lancet. 2017 Feb 25;389(10071):805-814. doi: 10.1016/S0140-6736(16)31588-4. Epub 2017 Jan 17.