Checklist to Prevent MRSA Surgical Site Infections

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02216227

Collaborator

(none)

1,794

Enrollment

Locations

Arm

Actual Duration (Months)

163.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty and cardiac surgery patients.
Implementation of the checklist will be associated with an overall reduction in SSIs caused by all pathogens.
The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.
Preoperative MRSA testing will be a modifiable barrier to implementing the SSI checklist.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Drug: Mupirocin Drug: Chlorhexidine gluconate Drug: Cefazolin Drug: Vancomycin Drug: Nasal Povidone Iodine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1794 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Checklist to Prevent MRSA Surgical Site Infections

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical Site Infection Checklist Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA): ecolonize with intranasal Mupirocin ointment BID x 5 days hlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid) efazolin plus Vancomycin (no Vanco for MSSA positive) Patient has a known negative Staph aureus pre-op screening result: HG bathing (night before & morning of surgery using wipes or liquid) efazolin Patient was not screened or results are unknown at time of surgery: ecolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen) HG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before & morning of surgery using wipes or liquid) efazolin plus Vancomycin	Drug: Mupirocin Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days Other Names: Bactroban Drug: Chlorhexidine gluconate Patients that are MRSA or MSSA positive or have unknown status will bathe in CHG daily x 5 days. Patients that are MRSA or MSSA negative will bathe with CHG the night before and morning of surgery. Other Names: Chlorhexidine Gluconate in IMS, CHG Drug: Cefazolin All patients will receive Cefazolin during surgery Other Names: Ancef, Kefzol Drug: Vancomycin Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery. Other Names: vancocin Drug: Nasal Povidone Iodine The purpose of this research is to evaluate a SSI checklist. This checklist includes decolonizing a patient's nose and skin and optimizing antibiotics prior to surgery. At the time that we wrote it, the predominate product to decolonize patient's noses was mupirocin. However, in 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist. Other Names: Povidone Iodine

Arm

Intervention/Treatment

Experimental: Surgical Site Infection Checklist

Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA): ecolonize with intranasal Mupirocin ointment BID x 5 days hlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid) efazolin plus Vancomycin (no Vanco for MSSA positive) Patient has a known negative Staph aureus pre-op screening result: HG bathing (night before & morning of surgery using wipes or liquid) efazolin Patient was not screened or results are unknown at time of surgery: ecolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen) HG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before & morning of surgery using wipes or liquid) efazolin plus Vancomycin

Drug: Mupirocin

Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days

Other Names:

Bactroban

Drug: Chlorhexidine gluconate

Patients that are MRSA or MSSA positive or have unknown status will bathe in CHG daily x 5 days. Patients that are MRSA or MSSA negative will bathe with CHG the night before and morning of surgery.

Other Names:

Chlorhexidine Gluconate in IMS, CHG

Drug: Cefazolin

All patients will receive Cefazolin during surgery

Other Names:

Ancef, Kefzol

Drug: Vancomycin

Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.

Other Names:

vancocin

Drug: Nasal Povidone Iodine

The purpose of this research is to evaluate a SSI checklist. This checklist includes decolonizing a patient's nose and skin and optimizing antibiotics prior to surgery. At the time that we wrote it, the predominate product to decolonize patient's noses was mupirocin. However, in 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist.

Other Names:

Povidone Iodine

Outcome Measures

Primary Outcome Measures

Superficial and deep/organ space MRSA infections [90 days postoperatively]
Superficial and deep/organ space MRSA infections, 90 days postoperatively.

Secondary Outcome Measures

Superficial and deep/organ space MRSA infections [one year postoperatively]
The investigators chose 90-days rather than 1 year for the primary outcome measure since not all patients in the study will be able to be followed for 1 year due to the timing of the study. However, since the investigators will be able to follow 83% of the cohort for 1-year post-operatively, the investigators will perform this secondary analysis in which the investigators will include only patients who were followed for one year. However, it is unlikely that the 90-day analysis and 1 year analysis will differ significantly because over 75% of SSIs are detected within 30 days, in fact most SSI manifest within 22 days.
Compliance with the entire pre-surgical bundle and individual bundle components [30-days pre-surgery to day of surgery]
This will be established electronically, through measurement of mupirocin prescription, CHG prescription and swab collection, as well as utilizing the compliance information collected on patient intake on the day of surgery.
Length of postoperative stay [Duration of postoperative stay, an expected average of 3 days]
Duration of postoperative stay, an expected average of 3 days.
All-cause mortality [Up to 1-year post-surgery]
All-cause mortality, Up to 1-year post-surgery.
Readmission [90-days postsurgery]
Readmission, 90-days postsurgery.
Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates [30-days pre-surgery to 90-days post-surgery]
The investigators will test bacterial isolates from MRSA positive patients at the 10 interventions sites. The VA is mandated to take nasal swabs from each patient preoperatively. For those patients who are MRSA positive, the investigators will have the bacterial isolates sent to the Iowa City site to be tested for resistance to mupirocin and CHG. The investigators will also collect bacterial isolates from patients who experience surgical site infections during the study. These isolates will also be tested for mupirocin and CHG resistance. The purpose of this testing is to a) ensure the investigators' study checklist does not cause mupirocin or CHG resistance by b) determining if resistance was present at the initial nasal swab, or if resistance occurred after performance of study checklist.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami VA Healthcare System, Miami, FL	Miami	Florida	United States	33125
2	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa	United States	52246-2208
3	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201
4	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130
5	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105
6	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota	United States	55417
7	Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE	Omaha	Nebraska	United States	68105-1873
8	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97239
9	South Texas Health Care System, San Antonio, TX	San Antonio	Texas	United States	78229
10	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah	United States	84148
11	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin	United States	53705