Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)

Healthcare Associated Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579370
• Other study ID #: Pro00032718
• Secondary ID: 1U54CK000164-01
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: November 15, 2015
• Start date: April 2012
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21395
• Est. completion date: August 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• Healthcare Associated Infections
• Infection
• Multidrug Resistant Organisms

Intervention

Other:
• Quaternary ammonium
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
• Bleach
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital.
• Quaternary ammonium and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.
• Bleach and UV-C light
Rooms from which a patient with a target organisms has been discharged (ie, a "seed" room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room.

Locations

Country	Name	City	State
United States	Alamance Regional Medical Center	Burlington	North Carolina
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Chesapeake Regional Medical Center	Chesapeake	Virginia
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham Regional Hospital	Durham	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	High Point Regional Health System	High Point	North Carolina
United States	Duke Raleigh Hospital	Raleigh	North Carolina
United States	Rex Healthcare	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical incidence rate of four target organisms among patients admitted to a study room	Patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. Cultures for vegetative bacteria (MRSA, VRE, Acinetobacter) will be included if obtained within 90 days of discharge from a seed room; cultures for C. difficile will be included if they are obtained within 28 days of discharge from a seed room.	90 days	No
Primary	Clinical incidence rate of C. difficile among patients admitted to a study room	Patients will be monitored for clinical cultures that grow C. difficile following admission to a "seed" room.	28 days	No
Secondary	Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room.	Patients will be monitored for clinical cultures that grow one of three target vegetative organisms (MRSA, VRE, and MDR-Acinetobacter) following admission to a "seed" room.	90 days	No
Secondary	Clinical incidence rate of target organisms among all patients admitted to the hospital	All hospitalized patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) regardless of exposure to seed room.	90 days	No
Secondary	Clinical incidence rate of MRSA among all patients admitted to the hospital	All hospitalized patients will be monitored for clinical cultures that grow MRSA regardless of exposure to seed room.	90 days	No
Secondary	Clinical incidence rate of VRE among all patients admitted to the hospital	All hospitalized patients will be monitored for clinical cultures that grow VRE regardless of exposure to seed room.	90 days	No
Secondary	Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital	All hospitalized patients will be monitored for clinical cultures that grow MDR-Acinetobacter regardless of exposure to seed room.	90 days	No
Secondary	Clinical incidence rate of C. difficile among all patients admitted to the hospital	All hospitalized patients will be monitored for clinical cultures that grow C. difficile regardless of exposure to seed room.	28 days	No
Secondary	Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room.	Patients will be monitored for HAIs due to one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room.	Patients will be monitored for HAIs due to MRSA following admission to a "seed" room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room.	Patients will be monitored for HAIs due to VRE following admission to a "seed" room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room.	Patients will be monitored for HAIs due to MDR-Acinetobacter following admission to a "seed" room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients.	Patients will be monitored for HAIs due to MDR-Acinetobacter, regardless of exposure to seed room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients.	Patients will be monitored for HAIs due to MRSA, regardless of exposure to seed room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients.	Patients will be monitored for HAIs due to VRE, regardless of exposure to seed room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients.	Patients will be monitored for HAIs due to MRSA, VRE, and MDR-Acinetobacter regardless of exposure to seed room. NHSN definitions for HAIs will be used.	Patients will be followed an average of 30 days	No
Secondary	Missed Opportunities	Use of UV-C emitting devices will be monitored and "missed opportunities" (ie, UV-C emitter should have been used per protocol and was not) will be tracked and summarized. This proportion will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.	each study period (6 months)	No
Secondary	Time on Diversion	Hospital data will be gathered to determine if use of UV-C emitting devices leads to downstream effects on hospital process. The proportion will be calculated as the average number of days on diversion per month for each study period. This proportion will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) will be considered the reference group.	Each study period (6 months)	No
Secondary	Room Turnover Time	Room cleaning process will be monitored and tracked. We will obtain start and stop times for terminal room cleaning to determine if use of UV-C light emitting devices leads to additional time for room turnover. Average times will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.	Each study period (6 months)	No
Secondary	ED to floor wait time	Hospital data will be gathered to determine if use of UV-C emitting devices leads to downstream effects on hospital process. Average times will be calculated for each study arm, each of which lasts 6 months. The "quaternary ammonium" (and no UV-C light) arm will be considered the reference group.	Each study period (6 months)	No
Secondary	Clinical incidence of MRSA, VRE, C. difficile, and MDR-Acinetobacter during UV-C light versus No UV-C light	The clinical incidence rate of MRSA, VRE, C. difficile, and MDR-Acinetobacter will be calculated for the two 6-month study arms (12 months total) during which UV-C light is used for terminal room disinfection (regardless of which chemical is used) and compared to the two 6-month study arms (12 months total) during which UV-C light is not used for terminal room disinfection.	12 months (2 6-month study arms combined)	No

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