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Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial

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ClinicalTrials.gov Identifier: NCT00563186
Recruitment Status : Unknown
Verified March 2009 by University of Calgary.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : March 10, 2009
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Study Description
Brief Summary:
The Physical plant design and the use of engineering controls significantly affects the acquisition and transmission of pathogenic organisms in a hospital environment.

Condition or disease Intervention/treatment Phase
Hospital-Acquired Infection With Clostridium Difficile Hospital-Acquired VRE Infection or Colonization Hospital-Acquired MRSA Infection or Colonization Other: Admission to a novel hospital ward Phase 3

Detailed Description:

Recent studies have underscored the importance of optimizing design standards to maximize patient and health care worker safety, including the prevention of hospital acquired infections (HAI) in patients. Health care associated infections are a major contributor to adverse events in healthcare, estimated to occur in 3-20% of all acute care admissions in Canada. A review of the role of the physical environment and adverse events identified no prospective randomized controlled trials of physical plant design and its impact on hospital acquired infections. With the construction in 2004 of a unique $5-million, 36-bed medical teaching unit at Foothills Medical Centre (FMC) with a prototypical design with features to reduce HAI and an overarching mandate to test new concepts in health care delivery, the opportunity exists to rigorously study the impact of design, construction and engineering controls (DCECs) on specific hospital acquired infections and antibiotic resistant organism (ARO) colonization. In the first year of operation the incidence density of hospital acquired infections and/or colonization with marker organisms has declined by almost 70%. Given that there were no changes in the types of patients, medical, nursing or housekeeping staff, we hypothesized that the design of the new ward was the major factor which contributed to the improved outcomes. Given the pre-post study design we are uncertain as to which factor is most important in reducing HAI /colonization rates.

We therefore propose to conduct a prospective, controlled investigator blinded trial of the impact of DCECs on specific HAIs and ARO colonization. We propose to allocate general medical patients, with an allocation scheme that incorporates randomness, to one of 2 types of medical wards at the FMC, either "historic design" wards (ie control wards in the non-renovated portions of FMC or Unit 36 (the experimental new design ward). The medical wards are very similar with respect to the patient mix, acuity of care, medical staff, nursing staff and skill mix, educational levels, housekeeping and levels of knowledge about infection control practices but differ in design. Variables which may otherwise have confounded the outcome of hospital acquired infections/colonizations may be controlled allowing the effect of the differences in design, construction and engineering controls to be studied. The older design wards have predominantly 4-bed and some 2-bed rooms with shared bathrooms, less space and fewer handwashing sinks/patient. The study will require 9750 patient days of observation in the "historic design"wards and 19,500 patient days of observation in Unit 36 to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units.

In addition we propose to add a nested mixed methods social science study within the construct of the prospective study to understand the fit between the health care workers and the physical environment. In recognition that the proposed intervention may be defined as a "complex intervention" with HAIs affected by many factors related to physical plant design, organizational factors, and health care worker practices, it was considered prudent to measure and describe worker and organizational factors on the medical inpatient care units included in the proposed intervention.

Our proposed study is being done with the collaboration and support of both the Operations and Planning & Capital Development portfolios of the Calgary Health Region. The Region is in the throes of a major expansion with over $1 billion of new capital health care developments and the addition of over 700 new beds by 2010. The finding of favorable outcomes on the medical ward with its special design, construction and engineered controls in a well designed prospective study of this nature would be the first of its kind and has the potential to change the fundamental design of new medical wards in the Calgary Health Region and in other jurisdictions within Canada.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Physical Plant Design and Engineering Controls and the Prevention of Nosocomial Infections and Antibiotic Resistant Organism Colonization Events - A Proposal for a Prospective Controlled Trial
Study Start Date : June 2007
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Hospital admission to a ward with novel infection control design features (e.g., abundance of sinks, predominance of private rooms, absence of shared bathrooms/curtains, etc.)
Other: Admission to a novel hospital ward
Hospital admission to a ward with novel infection control design features (e.g., abundance of sinks, predominance of private rooms, absence of shared bathrooms/curtains, etc.)
No Intervention: B
Hospital admission to a ward with traditional design features.

Outcome Measures

Primary Outcome Measures :
  1. Incidence of hospital-acquired infection with Clostridium difficile, and hospital-acquired infection or colonization with vancomycin-resistant Enterococcus (VRE), or methicillin-resistant Staphylococcus aureus (MRSA). [ Time Frame: in-hospital ]

Secondary Outcome Measures :
  1. Incidence of the same infections in room-mates of study subjects. (i.e., event rates in non-study patients who have contact with infected study subjects). [ Time Frame: in-hospital ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • are adults aged 18 or older with medical diagnoses being admitted to one of three in-hospital general medical services at the FMC (one of the two in-patient General Internal Medicine services at the FMC)
  • are admitted via the emergency room
  • are admitted from the urgent assessment clinic or the community

Exclusion Criteria:

  • are admitted from another acute care medical institution
  • require telemetry monitoring of their cardiac rhythm (a specific medical situation that dictates need for admission to a nonUnit 36 bed).
  • have other clinical circumstances (eg clinical instability) mandating a physician to indicate clinical preference for admission of the patient to a specific location in the hospital
  • are admitted from the intensive care unit or another hospital ward
  • are admitted for less than 48 hours
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563186

Contact: Jennifer JR Ellison, MSc 403 944-8222 Jennifer.Ellison@calgaryhealthregion.ca
Contact: William A Ghali, MD, MPH 403 210 9317 wghali@ucalgary.ca

Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Calgary Health Region
Canadian Institutes of Health Research (CIHR)
Alberta Heritage Foundation for Medical Research
Principal Investigator: John M Conly, MD University of Calgary
Principal Investigator: William A Ghali, MD University of Calgary
Principal Investigator: Manuel Mah, MD Calgary Health Region
Principal Investigator: Donna Holton, MD Calgary Health Region
Principal Investigator: Elizabeth A Henderson, PhD University of Calgary
Principal Investigator: Peter Faris, PhD University of Calgary
Principal Investigator: Jean Wallace, PhD University of Calgary
More Information

Additional Information:
Responsible Party: William Ghali, University of Calgary
ClinicalTrials.gov Identifier: NCT00563186     History of Changes
Other Study ID Numbers: CIHR-PHE-81963
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: March 10, 2009
Last Verified: March 2009

Keywords provided by University of Calgary:
infection control
nosocomial infection
hospital design
physical plant design
antibiotic resistant organisms

Additional relevant MeSH terms:
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes