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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01579370
First received: April 5, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Multidrug Resistant Organisms
Healthcare Associated Infections
Other: Quaternary ammonium
Other: Bleach
Other: Quaternary ammonium and UV-C light
Other: Bleach and UV-C light

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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clinical incidence rate of four target organisms among patients admitted to a study room [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.

  • Clinical incidence rate of C. difficile among patients admitted to a study room [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Patients will be monitored for clinical cultures that grow C. difficile following admission to a "seed" room.


Secondary Outcome Measures:
  • Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.

  • Clinical incidence rate of target organisms among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.

  • Clinical incidence rate of MRSA among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    All hospitalized patients will be monitored for clinical cultures that grow MRSA regardless of exposure to seed room.

  • Clinical incidence rate of VRE among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    All hospitalized patients will be monitored for clinical cultures that grow VRE regardless of exposure to seed room.

  • Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    All hospitalized patients will be monitored for clinical cultures that grow MDR-Acinetobacter regardless of exposure to seed room.

  • Clinical incidence rate of C. difficile among all patients admitted to the hospital [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    All hospitalized patients will be monitored for clinical cultures that grow C. difficile regardless of exposure to seed room.

  • Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    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.

  • Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    Patients will be monitored for HAIs due to MRSA following admission to a "seed" room. NHSN definitions for HAIs will be used.

  • Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    Patients will be monitored for HAIs due to VRE following admission to a "seed" room. NHSN definitions for HAIs will be used.

  • Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    Patients will be monitored for HAIs due to MDR-Acinetobacter following admission to a "seed" room. NHSN definitions for HAIs will be used.

  • Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    Patients will be monitored for HAIs due to MDR-Acinetobacter, regardless of exposure to seed room. NHSN definitions for HAIs will be used.

  • Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    Patients will be monitored for HAIs due to MRSA, regardless of exposure to seed room. NHSN definitions for HAIs will be used.

  • Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    Patients will be monitored for HAIs due to VRE, regardless of exposure to seed room. NHSN definitions for HAIs will be used.

  • Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ] [ Designated as safety issue: No ]
    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.

  • Missed Opportunities [ Time Frame: each study period (6 months) ] [ Designated as safety issue: No ]
    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.

  • Time on Diversion [ Time Frame: Each study period (6 months) ] [ Designated as safety issue: No ]
    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.

  • Room Turnover Time [ Time Frame: Each study period (6 months) ] [ Designated as safety issue: No ]
    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.

  • ED to floor wait time [ Time Frame: Each study period (6 months) ] [ Designated as safety issue: No ]
    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.

  • Clinical incidence of MRSA, VRE, C. difficile, and MDR-Acinetobacter during UV-C light versus No UV-C light [ Time Frame: 12 months (2 6-month study arms combined) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50000
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quaternary ammonium
Rooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals.
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.
Experimental: Bleach
Rooms will be terminally cleaned using bleach-containing products.
Other: 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.
Experimental: Quaternary ammonium and UV-C light
Rooms will be terminally cleaned with quaternary ammonium-containing solutions followed by irradiation by a UV-C light emitting device.
Other: 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.
Experimental: Bleach and UV-C light
Rooms will be terminally cleaned with bleach-containing solutions followed by irradiation by a UV-C light emitting device.
Other: 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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579370

Locations
United States, North Carolina
Alamance Regional Medical Center
Burlington, North Carolina, United States, 27215
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
Durham VA Medical Center
Durham, North Carolina, United States, 27710
Durham Regional Hospital
Durham, North Carolina, United States, 27704
Duke University Medical Center
Durham, North Carolina, United States, 27710
High Point Regional Health System
High Point, North Carolina, United States, 27261
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Rex Healthcare
Raleigh, North Carolina, United States, 27607
United States, Virginia
Chesapeake Regional Medical Center
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Daniel J Sexton, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01579370     History of Changes
Other Study ID Numbers: Pro00032718, 1U54CK000164-01
Study First Received: April 5, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
healthcare associated infections
multidrug resistant organisms
methicillin resistant staphylococcus aureus
vancomycin resistant enterococcus
clostridium difficile
acinetobacter

ClinicalTrials.gov processed this record on July 31, 2014