Checklist to Prevent MRSA Surgical Site Infections



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:April 1, 2014
End Date:September 30, 2019
Contact:Eli N Perencevich, MD MS BS
Email:eli.perencevich@va.gov
Phone:(319) 338-0581

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The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the
checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to
assess barriers and facilitators to checklist implementation.

Hypotheses:

1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty
and cardiac surgery patients.

2. Implementation of the checklist will be associated with an overall reduction in SSIs
caused by all pathogens.

3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.

4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI
checklist.

Aims and Design: Methicillin-resistant Staphylococcus aureus (MRSA), accounts for an
estimated 94,000 invasive infections and 19,000 deaths annually in the U.S. In order to
prevent MRSA infections among Veterans, the VA successfully implemented the VA MRSA
Prevention Initiative that has reduced patient-to-patient transmission of MRSA. However, this
Initiative does not prevent most MRSA surgical site infections (SSIs) because MRSA SSIs are
usually caused by MRSA transferring from a patient's nose to their own surgical incision
site. Cardiac surgery and total joint arthroplasty (TJA; e.g. hip or knee surgery) are among
the most common operations performed by the VA and are associated with particularly high
clinical and economic impact. In order to eliminate MRSA SSIs in the VA, the study group
developed a checklist based on a meta-analysis of studies that assessed methods to prevent
gram-positive SSIs among TJA and cardiac surgery patients. This SSI Checklist includes
preoperatively testing a surgical patient's nose for asymptomatic MRSA colonization. If the
patient is MRSA colonized, s/he will be treated with prophylactic nasal mupirocin ointment,
chlorhexidine gluconate baths, and antibiotic prophylaxis with both cefazolin and vancomycin.
The SSI Checklist will be implemented in 10 VA Medical Centers (VAMCs). A high-quality
quasi-experimental study, with a qualitative process evaluation will be performed to assess
the SSI Checklist. The goals of this project are 1) to assess the effectiveness and
cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or
cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation.

Methods: This study includes both quantitative and qualitative components. In the
quantitative component, the SSI Checklist will be implemented in 10 VAMCs for 3 years and
outcomes will be compared between the intervention group and two control groups: 1) 5 years
of historic data from the same 10 VAMCs, 2) 8 years (5 historic year and 3 intervention
years) of concurrent data from other VAMCs that did not implement the SSI Checklist. Study
endpoints will include: 1) MRSA SSIs as defined by the Centers for Disease Control and
Prevention (CDC); 2) SSIs caused by other pathogens; 3) cost per SSI prevented, cost per
life-saved, cost per MRSA SSI prevented and cost per quality-adjusted life-year (QALY) saved.
VA databases including VA National Surgical Quality Improvement Program (VASQIP), VA Decision
Support System, VA Inpatient Evaluation Center (IPEC) and Veterans' Informatics & Computing
Infrastructure (VINCI) will be used to collect data. Time series analysis and linear mixed
effects models will be used for the statistical analysis. In the qualitative component, a
process evaluation will be conducted at 6 different VAMCs, which includes collecting data
before, during and after implementation, to examine the contextual factors and stakeholder
perspectives that influence adoption of the SSI Checklist. Observations and semi-structured
interviews will be conducted in Years 1 and 3, along with thematic content analysis, to
examine facilitators and barriers to the implementation at the different study sites. The
Consolidated Framework for Implementation Research will be used to guide the process
evaluation and provide the foundation for a systematic evaluation of local contextual factors
that influence implementation of the SSI Checklist. The products of this study include a
validated SSI Checklist, a business-case analysis, an implementation toolkit, and a team
experienced in checklist implementation for prevention of infections. At the end of this
study period, the study team will meet with operational partners including National
Infectious Disease Program Office (NIDS) and the MRSA / Multidrug-resistant Program Office
(MDRO), and the National Center for Occupational Health and Infection Control (COHIC) to
discuss implementing this checklist nationwide as part of the VA MRSA Prevention Initiative.
This study has high potential to significantly decrease SSI, and in turn morbidity and
mortality due to SSIs, in our Nation's Veterans.

Inclusion Criteria:

Retrospective Control Group Inclusion Criteria:

- Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as
undergoing total joint arthroplasty or cardiac surgery at the 10 intervention VA
Medical Centers during the 5 year preintervention period (2008-2013)

Concurrent Non-equivalent Control Group Inclusion Criteria:

- Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as
undergoing total joint arthroplasty or cardiac surgery at VA Medical Centers not
included in the intervention group during the 8 years evaluated (5 years
pre-intervention to match with the retrospective control group and 3 years of the
intervention.)

Exclusion Criteria:

For All Patient Groups:

- Have an ICD-9 diagnosis code consistent with endocarditis

- Have any documented infection before the surgical procedure

- Undergo cardiac transplants or cardiac procedures performed using the percutaneous or
thoracotomy approach

- Undergoing hip and knee revisions

- Documented allergies to mupirocin
We found this trial at
11
sites
Ann Arbor, Michigan 48113
Phone: 734-845-3072
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Baltimore, Maryland 21201
Phone: (410) 706-1734
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Boston, Massachusetts 02130
Phone: 857-203-5086
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Iowa City, Iowa 52246
Principal Investigator: Eli N. Perencevich, MD MS BS
Phone: 319-338-0581
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Iowa City, IA
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Madison, Wisconsin 53705
Phone: (608) 256-1901
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Madison, WI
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Miami, Florida 33125
Phone: 305-575-7000
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Miami, FL
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Minneapolis, Minnesota 55417
Phone: 612-467-6907
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Minneapolis, MN
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Omaha, Nebraska 68105
Phone: 402-995-5219
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Portland, Oregon 97201
Phone: 503-220-8262
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Portland, OR
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Salt Lake City, Utah 84148
Phone: (801) 582-1565
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San Antonio, Texas 78229
Phone: 210-617-5300
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San Antonio, TX
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