Checklist to Prevent MRSA Surgical Site Infections

NCT ID: NCT02216227

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1794 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2021-02-28

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:

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.

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mupirocin

Intervention Type: DRUG

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

Chlorhexidine gluconate

Intervention Type: DRUG

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

Intervention Type: DRUG

All patients will receive Cefazolin during surgery

Vancomycin

Intervention Type: DRUG

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

Nasal Povidone Iodine

Intervention Type: DRUG

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.

Interventions

Mupirocin

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

Intervention Type: 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.

Intervention Type: DRUG

Cefazolin

All patients will receive Cefazolin during surgery

Intervention Type: DRUG

Vancomycin

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Bactroban; Chlorhexidine Gluconate in IMS, CHG; Ancef, Kefzol; vancocin; Povidone Iodine

Eligibility Criteria

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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eli N. Perencevich, MD MS BS

Role: PRINCIPAL_INVESTIGATOR

Iowa City VA Health Care System, Iowa City, IA

Locations

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 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

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 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

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28593043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28873140 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 25979001 (View on PubMed)

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 Forum Infect Dis. 2019 Oct 19;6(11):ofz451. doi: 10.1093/ofid/ofz451. eCollection 2019 Nov.

Reference Type: RESULT

PMID: 31737738 (View on PubMed)

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 diseases. 2019 Oct 23; 6(Supplement_2):S240-S241.

Reference Type: RESULT

Hockett Sherlock S, Goedken CC, Balkenende EC, Dukes KC, Perencevich EN, Reisinger HS, Forrest GN, Pfeiffer CD, West KA, Schweizer M. Strategies for the implementation of a nasal decolonization intervention to prevent surgical site infections within the Veterans Health Administration. Front Health Serv. 2022 Aug 17;2:920830. doi: 10.3389/frhs.2022.920830. eCollection 2022.

Reference Type: DERIVED

PMID: 36925849 (View on PubMed)

Other Identifiers

CRE 12-291

Identifier Type: -

Identifier Source: org_study_id