Trial Outcomes & Findings for Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial (NCT NCT00563186)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1514 participants

Primary outcome timeframe

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

Results posted on

2018-10-23

Participant Flow

Between June 2007 and February 2010 all patients admitted to the General Internal Medicine Service at Foothills Medical Centre from the emergency room, urgent assessment clinic or the community were assessed for eligibility into the study.

Exclusions: admitted from another health care facility or another hospital ward or to a non-study unit, required telemetry, \< 18 years of age, or were preferentially admitted to the novel or the traditional design ward. Once pre-assigned, excluded if LOS \<48 hours (Novel ward=97, Historic ward=74); or data incomplete (Novel ward=1; Historic ward=1)

Participant milestones

Participant milestones
Measure	Novel Hospital Ward Admission 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)	Traditional Hospital Ward Admission Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
Overall Study STARTED	1008	679
Overall Study COMPLETED	910	604
Overall Study NOT COMPLETED	98	75

Reasons for withdrawal

Reasons for withdrawal
Measure	Novel Hospital Ward Admission 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)	Traditional Hospital Ward Admission Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
Overall Study LOS<48 hours	97	74
Overall Study Incomplete data	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novel Hospital Ward Admission n=910 Participants 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)	Traditional Hospital Ward Admission n=604 Participants Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)	Total n=1514 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	400 Participants n=99 Participants	305 Participants n=107 Participants	705 Participants n=206 Participants
Age, Categorical >=65 years	510 Participants n=99 Participants	299 Participants n=107 Participants	809 Participants n=206 Participants
Age, Continuous	60.62 years STANDARD_DEVIATION 18.44 • n=99 Participants	63.22 years STANDARD_DEVIATION 18.78 • n=107 Participants	61.66 years STANDARD_DEVIATION 18.61 • n=206 Participants
Sex: Female, Male Female	407 Participants n=99 Participants	278 Participants n=107 Participants	685 Participants n=206 Participants
Sex: Female, Male Male	503 Participants n=99 Participants	326 Participants n=107 Participants	829 Participants n=206 Participants
Region of Enrollment Canada	910 participants n=99 Participants	604 participants n=107 Participants	1514 participants n=206 Participants

PRIMARY outcome

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

Population: All patients meeting inclusion criteria, and admitted to the General Internal Medicine (GIM) service on the novel infection control design ward or the traditional infection control design ward were followed for the development of MRSA or VRE infection (inf) or colonization (col) or CDI after 48 hours of admission

Outcome measures

Outcome measures
Measure	Novel Hospital Ward Admission n=910 Participants 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)	Traditional Hospital Ward Admission n=604 Participants Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
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). CDI	1.16 events per 1000 patient days	0.84 events per 1000 patient days
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). MRSA Infections / Colonizations	1.27 events per 1000 patient days	1.01 events per 1000 patient days
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). VRE Infections / Colonizations	0.53 events per 1000 patient days	0 events per 1000 patient days
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). Overall Total Infections / Colonizations	2.96 events per 1000 patient days	1.85 events per 1000 patient days

SECONDARY outcome

Timeframe: in-hospital

Population: An outbreak occurred when more than 1 case of MRSA, VRE or CDI was epidemiologically linked to a primary case. In total 22 outbreak cases were detected during the study. The location of these outbreak cases (single-bed rooms vs. multi-bed rooms) was identified in the Novel Hospital Ward and the Traditional Hospital Ward

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.

Outcome measures

Outcome measures
Measure	Novel Hospital Ward Admission n=22 Total Number of Outbreak cases 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)	Traditional Hospital Ward Admission Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
Number of MRSA, VRE and CDI Occurring in Single-bed Rooms vs. Multiple Bed Rooms AND Occurring in Outbreaks Related to the Primary Case Single-bed Rooms	3 outbeak infections/colonizations	—
Number of MRSA, VRE and CDI Occurring in Single-bed Rooms vs. Multiple Bed Rooms AND Occurring in Outbreaks Related to the Primary Case Multiple-bed rooms	19 outbeak infections/colonizations	—

POST_HOC outcome

Timeframe: In-hospital

Population: All patients that met the inclusion and exclusion categories and were admitted to the novel design ward were assessed for the development of MRSA, VRE or CDI. The incidence densities in single-bed rooms were then compared to the incidence densities in multiple-bed rooms.

The incidence density of MRSA, VRE and CDI occurring in single-bed vs. multi-bed rooms was examined on only the novel design ward

Outcome measures

Outcome measures
Measure	Novel Hospital Ward Admission n=256 Participants 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)	Traditional Hospital Ward Admission n=654 Participants Hospital admission to a ward with traditional infection control design features (e.g. lack of sinks, predominance (80%) of 4-bed rooms, shared bathrooms)
Event Incidence Density in Single vs Multi-bed Rooms in Novel Design Ward Only	1.89 events per 1000 patient days	3.47 events per 1000 patient days

Adverse Events

Novel Hospital Ward Admission

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Hospital Ward Admission

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Conly

University of Calgary

Phone: 403-944-8090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place