Checklist to Prevent MRSA Surgical Site Infections

Surgical Site Infection Clinical Trial

Official title:

Checklist to Prevent MRSA Surgical Site Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216227
• Other study ID #: CRE 12-291
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1794
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Mupirocin
Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days
• 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.
• Cefazolin
All patients will receive Cefazolin during surgery
• Vancomycin
Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin
United States	Miami VA Healthcare System, Miami, FL	Miami	Florida
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE	Omaha	Nebraska
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (5)

Carrel M, Goto M, Schweizer ML, David MZ, Livorsi D, Perencevich EN. Diffusion of clindamycin-resistant and erythromycin-resistant methicillin-susceptible Staphylococcus aureus (MSSA), potential ST398, in United States Veterans Health Administration Hospitals, 2003-2014. Antimicrob Resist Infect Control. 2017 Jun 5;6:55. doi: 10.1186/s13756-017-0212-1. eCollection 2017. — View Citation

Goto M, Schweizer ML, Vaughan-Sarrazin MS, Perencevich EN, Livorsi DJ, Diekema DJ, Richardson KK, Beck BF, Alexander B, Ohl ME. Association of Evidence-Based Care Processes With Mortality in Staphylococcus aureus Bacteremia at Veterans Health Administration Hospitals, 2003-2014. JAMA Intern Med. 2017 Oct 1;177(10):1489-1497. doi: 10.1001/jamainternmed.2017.3958. Erratum in: JAMA Intern Med. 2017 Oct 1;177(10):1544. — View Citation

Pfeiffer CD, Williams HB, Flegal H, Klutts JS, Evans M, Jones MM. 493. Laboratory Evaluation and Epidemiology of Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae in Department of Veterans Affairs, 2017. [Abstract]. Open forum infectious dis

Safdar N, Perencevich E. Crossing the quality chasm for Clostridium difficile infection prevention. BMJ Qual Saf. 2015 Jul;24(7):409-11. doi: 10.1136/bmjqs-2015-004344. Epub 2015 May 15. — View Citation

Singh N, Nair R, Goto M, Carvour ML, Carnahan R, Field EH, Lenert P, Vaughan-Sarrazin M, Schweizer ML, Perencevich EN. Risk of Recurrent Staphylococcus aureus Prosthetic Joint Infection in Rheumatoid Arthritis Patients-A Nationwide Cohort Study. Open Foru — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superficial and deep/organ space MRSA infections	Superficial and deep/organ space MRSA infections, 90 days postoperatively.	90 days postoperatively
Secondary	Superficial and deep/organ space MRSA infections	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.	one year postoperatively
Secondary	Compliance with the entire pre-surgical bundle and individual bundle components	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.	30-days pre-surgery to day of surgery
Secondary	Length of postoperative stay	Duration of postoperative stay, an expected average of 3 days.	Duration of postoperative stay, an expected average of 3 days
Secondary	All-cause mortality	All-cause mortality, Up to 1-year post-surgery.	Up to 1-year post-surgery
Secondary	Readmission	Readmission, 90-days postsurgery.	90-days postsurgery
Secondary	Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates	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.	30-days pre-surgery to 90-days post-surgery