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

NCT ID: NCT00563186

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1514 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-02-28

Brief Summary

With the construction of a new medical teaching ward with features designed to reduce hospital-acquired infections, we hypothesized that the design of the new ward was the major factor that contributed to the improved outcomes and designed a prospective, controlled study to examine this hypothesis.

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.

Conditions

Vancomycin Resistant Enterococci Infection; Clostridium Difficile Infection; Nosocomial Infection; Methicillin Resistant Staphylococcus Aureus Infection (MRSA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A

Admission to a novel hospital ward (e.g. abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms, absence of curtains)

Group Type: EXPERIMENTAL

Admission to a novel hospital ward

Intervention Type: OTHER

Hospital admission to a ward with novel infection control design features (e.g., abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms, absence of curtains)

B

Hospital admission to a ward with traditional design features (eg. lack of sinks, predominance of 4-bed rooms \[80%\], shared bathrooms, curtains present)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Admission to a novel hospital ward

Hospital admission to a ward with novel infection control design features (e.g., abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms, absence of curtains)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Calgary Health Region

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Alberta Heritage Foundation for Medical Research

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Conly

Dr John Conly

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John M Conly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

William A Ghali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Manuel Mah, MD

Role: PRINCIPAL_INVESTIGATOR

Calgary Health Region

Donna Holton, MD

Role: PRINCIPAL_INVESTIGATOR

Calgary Health Region

Elizabeth A Henderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Peter Faris, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Jean Wallace, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Hospital

Calgary, Alberta, Canada

Countries

Canada

Related Links

http://www.w21c.org

Website for the Medical Ward of the 21st Century Initiative.

Other Identifiers

CIHR-PHE-81963

Identifier Type: -

Identifier Source: org_study_id