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

NCT00563186 | Completed Results

• 1 other identifier: CIHR-PHE-81963
• Study Type: interventional
• Target: 1,514
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

infection control; nosocomial infection; hospital design; physical plant design; antibiotic resistant organisms; MRSA; VRE; CDI

Outcome Measures

Primary Outcomes (1)

• Incidence Density of Hospital-acquired Infection With Clostridium Difficile (CDI), and Hospital-acquired Infection or Colonization With Vancomycin-resistant Enterococcus (VRE), or Methicillin-resistant Staphylococcus Aureus (MRSA).

  participants were followed for the duration of hospital stay, an average of 10 days

Secondary Outcomes (1)

• Number of MRSA, VRE and CDI Occurring in Single-bed Rooms vs. Multiple Bed Rooms AND Occurring in Outbreaks Related to the Primary Case

  in-hospital

Study Arms (2)

A

EXPERIMENTAL

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

Other: Admission to a novel hospital ward

B

NO INTERVENTION

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

Interventions

Admission to a novel hospital ward 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)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Calgary Health Region: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Heritage Foundation for Medical Research: collaborator

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

Related Links

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

MeSH Terms

Conditions

Clostridium Infections; Cross Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Chronic overcapacity issues impacted the ability to truly randomize which may have introduced a selection bias,there was an unanticipated conversion of single rooms to multi-bed rooms on the novel ward, limited generalizability outside GIM patients

Results Point of Contact

• Title: Dr. John Conly
• Organization: University of Calgary

John.Conly@albertahealthservices.ca

403-944-8090

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr John Conly

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)