Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
Conditions
Keywords
HAI, MRSA, VRE
Brief summary
The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are: * Arm 1: Routine Care Routine policy for showering/bathing * Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen Note that enrolled subjects represents 53 individual HCA Hospitals (representing \ 190 non-critical care units) that have been randomized.
Interventions
DRUGArm 2: Decolonization
Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients. Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.
Sponsors
Harvard Medical School (HMS and HSDM)
Harvard Pilgrim Health Care
Hospital Corporation of America
Rush University
Cook County Health
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All HCA hospitals that reside in the United States * Note: Unit of randomization is the hospital, but the participants are hospital units
Exclusion criteria
* Non-critical care units where chlorhexidine bathing or decolonization for MRSA+ non-critical care patients is routine * Pediatric, peri-partum, rehabilitation, psychiatry, and BMT units * Units with \>30% cardiac or hip/knee orthopedic surgeries * Unit average length of stay \<2 days * Patients \<12 years-old * Patients with known allergy to mupirocin or chlorhexidine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRSA and VRE Clinical Cultures | 21 months | Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Bloodstream Infections | 21 months | All-cause bloodstream infections attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures. |
| Gram-negative Multi-drug Resistant Organism Clinical Cultures | 21 months | Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clostridium Difficile Infection | 21 months | Clostridium difficile Infection attributable to participating units |
| 30-Day Infectious Readmissions | 21 months | 30-Day Infectious Readmissions among patients in participating units |
| Emergence of Resistance to Chlorhexidine or Mupirocin | 21 months | Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units |
| Cost Effectiveness | 21 months | Cost effectiveness of routine care vs decolonization |
| Urinary Tract Infections | 21 months | Urinary tract infections attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge |
| Blood Culture Contamination | 21 months | Blood culture contamination |
Countries
United States
Participant flow
Recruitment details
The Participant Flow section reflects numbers of hospitals that were enrolled in the intervention (the unit of enrollment and randomization was hospital), as well as the number of participants included in analysis, (the number of patient admissions from participating units in the enrolled hospitals), in each arm during the intervention period.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Usual Care Routine policy for showering or bathing non-critical care patients | 156,889 |
| Arm 2: Decolonization Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.
Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.
Arm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.
Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen. | 183,013 |
| Total | 339,902 |
Baseline characteristics
| Characteristic | Arm 1: Usual Care | Arm 2: Decolonization | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 18.2 | 62.6 years STANDARD_DEVIATION 18.6 | 62.4 years STANDARD_DEVIATION 18.4 |
| Race/Ethnicity, Customized Asian | 2021 Participants | 4175 Participants | 6196 Participants |
| Race/Ethnicity, Customized Black | 21501 Participants | 22462 Participants | 43963 Participants |
| Race/Ethnicity, Customized Hispanic | 22581 Participants | 38704 Participants | 61285 Participants |
| Race/Ethnicity, Customized Other/Unknown | 3525 Participants | 5605 Participants | 9130 Participants |
| Race/Ethnicity, Customized White | 107261 Participants | 112067 Participants | 219328 Participants |
| Region of Enrollment United States | 156889 participants | 183013 participants | 339902 participants |
| Sex: Female, Male Female | 84585 Participants | 100249 Participants | 184834 Participants |
| Sex: Female, Male Male | 72288 Participants | 82748 Participants | 155036 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 156,889 | 0 / 183,013 |
| other Total, other adverse events | 0 / 156,889 | 25 / 183,013 |
| serious Total, serious adverse events | 0 / 156,889 | 0 / 183,013 |
Outcome results
Primary
MRSA and VRE Clinical Cultures
Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | MRSA and VRE Clinical Cultures | 0.87 Hazard Ratio (Intervention vs Baseline) |
| Arm 2: Decolonization | MRSA and VRE Clinical Cultures | 0.79 Hazard Ratio (Intervention vs Baseline) |
p-value: 0.17Mixed Models Analysis
Secondary
All-cause Bloodstream Infections
All-cause bloodstream infections attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | All-cause Bloodstream Infections | 0.96 Hazard Ratio |
| Arm 2: Decolonization | All-cause Bloodstream Infections | 0.90 Hazard Ratio |
p-value: 0.43Mixed Models Analysis
Secondary
Gram-negative Multi-drug Resistant Organism Clinical Cultures
Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | Gram-negative Multi-drug Resistant Organism Clinical Cultures | 0.81 Hazard Ratio (Intervention vs Baseline) |
| Arm 2: Decolonization | Gram-negative Multi-drug Resistant Organism Clinical Cultures | 0.91 Hazard Ratio (Intervention vs Baseline) |
p-value: 0.16Mixed Models Analysis
Other Pre-specified
30-Day Infectious Readmissions
30-Day Infectious Readmissions among patients in participating units
Time frame: 21 months
Post Hoc
All-cause Bloodstream Infections Among Patients With Devices
Sub-population analysis: All-cause bloodstream infections attributable to participating units (defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | All-cause Bloodstream Infections Among Patients With Devices | 1.13 Hazard Ratio |
| Arm 2: Decolonization | All-cause Bloodstream Infections Among Patients With Devices | 0.81 Hazard Ratio |
p-value: 0.0032Mixed Models Analysis
Other Pre-specified
Blood Culture Contamination
Blood culture contamination
Time frame: 21 months
Other Pre-specified
Clostridium Difficile Infection
Clostridium difficile Infection attributable to participating units
Time frame: 21 months
Other Pre-specified
Cost Effectiveness
Cost effectiveness of routine care vs decolonization
Time frame: 21 months
Other Pre-specified
Emergence of Resistance to Chlorhexidine or Mupirocin
Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units
Time frame: 21 months
Post Hoc
MRSA and VRE Clinical Cultures Among Patients With Devices
Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units (defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | MRSA and VRE Clinical Cultures Among Patients With Devices | 1.17 Hazard Ratio |
| Arm 2: Decolonization | MRSA and VRE Clinical Cultures Among Patients With Devices | 0.80 Hazard Ratio |
p-value: <0.001Mixed Models Analysis
Post Hoc
MRSA Clinical Cultures Among Patients With Devices
Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) clinical cultures attributable to participating units (defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | MRSA Clinical Cultures Among Patients With Devices | 1.17 Hazard Ratio |
| Arm 2: Decolonization | MRSA Clinical Cultures Among Patients With Devices | 0.87 Hazard Ratio |
p-value: 0.0126Mixed Models Analysis
Other Pre-specified
Urinary Tract Infections
Urinary tract infections attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge
Time frame: 21 months
Post Hoc
VRE Clinical Cultures Among Patients With Devices
Sub-population analysis: Vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units (defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).
Time frame: 21 months
Population: Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Usual Care | VRE Clinical Cultures Among Patients With Devices | 1.26 Hazard Ratio |
| Arm 2: Decolonization | VRE Clinical Cultures Among Patients With Devices | 0.58 Hazard Ratio |
p-value: 0.002Mixed Models Analysis