Vancomycin Resistant Enterococci InfectionNCT00563186
Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial
A study testing Admission to a novel hospital ward in people with Vancomycin Resistant Enterococci Infection and Clostridium Difficile Infection, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin Resistant Enterococci Infection, Clostridium Difficile Infection, Nosocomial Infection
- What is being tested?
- Admission to a novel hospital ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,514 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Being tested
- Admission to a novel hospital ward
- Keywords
- infection control, nosocomial infection, hospital design, physical plant design, antibiotic resistant organisms, MRSA, VRE, CDI
- Medical subject headings
- Clostridium Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Admission to a novel hospital wardOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
If a patient is swabbed and found to be positive (for MRSA or VRE), their current roommate\roommates will be swabbed (if in the same room > 48 hrs) as well as any other patient that shared a room with this patient for > 48 hours during this stay. Any patient who may have shared a bathroom with the first patient would also be swabbed. If the results from this investigation showed any positive roommates, then the process would repeat for each positive patient. Then, in consult with the infectious disease physician, a call will be made regarding a point prevalence study to determine the attack rate\burden of disease on the unit.
Measured: in-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vancomycin Resistant Enterococci InfectionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,514 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Calgary Health Region, Canadian Institutes of Health Research (CIHR), Alberta Heritage Foundation for Medical Research
- Responsible party
- Principal investigator, Dr. John Conly, University of Calgary
- Investigators
- John M Conly, MD, Principal investigator, University of CalgaryWilliam A Ghali, MD, Principal investigator, University of CalgaryManuel Mah, MD, Principal investigator, Calgary Health RegionDonna Holton, MD, Principal investigator, Calgary Health RegionElizabeth A Henderson, PhD, Principal investigator, University of CalgaryPeter Faris, PhD, Principal investigator, University of CalgaryJean Wallace, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563186
- Sponsor's protocol ID
- CIHR-PHE-81963
- Status last verified
- Oct 2018
- First submitted
- 21 Nov 2007
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Published: J Ellison, D Southern, D Holton, et al. Hospital ward design and prevention of hospital-acquired infections: A prospective clinical trial. Can J Infect Dis Med Microbiol 2014;25(5):265-270. Data was coded and entered into a computer for analysis and was non-nominal to protect the privacy of the information. Since the data were bed-specific, we will not be sharing the de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00563186
- Acronym / sponsor ID
- CIHR-PHE-81963
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,514 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Calgary Health Region, Canadian Institutes of Health Research (CIHR), Alberta Heritage Foundation for Medical Research
- Study start
- Jun 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Admission to a novel hospital wardAdmission to a novel hospital ward (e.g. abundance of sinks, predominance (80%) of private rooms, absence of shared bathrooms, absence of curtains) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Admission to a novel hospital wardHospital 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) | Other | A |
Primary outcome
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).
Time frame: participants were followed for the duration of hospital stay, an average of 10 days
1 secondary outcome
Number of MRSA, VRE and CDI Occurring in Single-bed Rooms vs. Multiple Bed Rooms AND Occurring in Outbreaks Related to the Primary Case
Time frame: in-hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Website for the Medical Ward of the 21st Century Initiative.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Published: J Ellison, D Southern, D Holton, et al. Hospital ward design and prevention of hospital-acquired infections: A prospective clinical trial. Can J Infect Dis Med Microbiol 2014;25(5):265-270. Data was coded and entered into a computer for analysis and was non-nominal to protect the privacy of the information. Since the data were bed-specific, we will not be sharing the de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Conly, MD principal investigator
University of Calgary
William A Ghali, MD principal investigator
University of Calgary
Manuel Mah, MD principal investigator
Calgary Health Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Admission to a novel hospital ward in people with Vancomycin Resistant Enterococci Infection and Clostridium Difficile Infection, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: participants were followed for the duration of hospital stay, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.