Surgical Antibiotic Prophylaxis: What Happens When SCIP Skips the Evidence Base? NOTIFICATIONS CHART Institute, LLC is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association, an accredited approver by the American Nurses Credentialing Center s Commission on Accreditation The planning committee members and faculty have declared no conflicts of interest CHART Institute, LLC has received no commercial support for this program CONTACT HOURS This webinar has been approved for 1 contact hour Successful completion of this program requires your attendance of the entire session and submission of an evaluation form by May 4, 2017 Information on accessing the evaluation form will be provided at the end of the program and post-webinar email 1
Webinar Control Panel Surgical Antibiotic Prophylaxis: What Happens When SCIP Skips the Evidence Base? Handouts Surgical Antibiotic Prophylaxis: What Happens When SCIP Skips the Evidence Base? Submit Questions Surgical Antibiotic Prophylaxis: What Happens When SCIP Skips the Evidence Base? 2
Surgical Antibiotic Prophylaxis: What Happens When SCIP Skips the Evidence Base? Dr. Harte's professional experience spans 31 years. He is currently the Assistant Professor of Clinical Anesthesiology at Bassett Medical Center and Columbia University and a recipient of a Master's of Science Degree in Quality and Safety in Healthcare from the Thomas Jefferson School of Population Health. Dr. Francis Harte Attending Anesthesiologist Bassett Medical Center Learning Outcomes At the end of this webinar, the participant will be able to Discuss institution s compliance with the CDC guidelines for surgical antibiotic re dosing in surgeries extending beyond four hours Describe the critical organizational behavioral change elements when undertaking a quality performance improvement initiative Atul Gawande, M.D. 3
When would you like the Ancef re-dosed? Is one gram enough? Surgical Site Infections Recent increase in hospital surgical site infection rate Impact of value-based payment on reimbursement Hospital reputation at risk Lack of widespread utilization of current evidence-based clinical pathways Clinical suspicion that surgical antibiotic prophylaxis practice was not evidence-based Awareness that surgical site infections lead to increased patient morbidity, mortality and hospital costs Ted Kaufman, MD. Kelly Bach, PhD. Nancy Kern, CRNA. Rachel Nolan, RN. Project Team Members James Trusdell, RN. Kelly Rudd, PhD. Matthew Van Kampen, PhD. Francis Harte, MD. 4
Surgical Site Infection CDC defines an SSI as an infection occurring within 30 days of an operative procedure, or 90 days if prosthetic material is implanted Most common and costliest healthcare-associated infection Estimated to occur in 2-5% of the 48 million surgeries per year in the United States 8,205 deaths associated with SSI s/year 3.2 billion dollars in cost attributable to SSI s occurring in acute care hospitals CDC/NHSN Protocol Corrections, clarifications And Additions. April, 2013. https://www.cdc.gov/nhsn/pdf/pscmanual/errata2013.pdf. Zimlichman, E., Henderson, D., Tamir, O., etal. (2013). Healthcare-Associated Infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med 173:2039. Do We Have A Problem? CDC Guidelines for Surgical Antibiotic Prophylaxis, published in 2013, selected institutionally as best practice. The CDC guidelines were consensus driven and evidence-based clinical recommendations for the selection and dosing of initial and maintenance antibiotics utilized in surgical procedures. The CDC clinical practice guidelines for antimicrobial prophylaxis in surgery were consensus driven employing four healthcare sub-specialty disciplines: The American Society of Health-System Pharmacists The Infectious Disease Society of America The Surgical Infection Society The Society of Healthcare Epidemiology of America Bratzler, DW., Dellinger, EP.,Olsen, KM., et.al. (2013). Clinical practice guidelines for antimicrobial prophylaxis in surgery. American Journal Health-Systems Pharmacology. 70:195-283. CDC Guideline Recommendations For SAP: Key Points To ensure a minimum inhibitory concentration of the antibiotic is realized in the serum and tissue: > The optimal time for the administration of pre-a antibiotics is within 60 minutes of incision. > Maintenance antibiotic re-dosing should occur at time intervals equal to 2x the halflife of the antibiotic. > Antibiotics should be re-dosed when the intra-operative blood loss reaches 1500 ml. > Antibiotic dosing should be weight-based. > Maintenance antibiotic dosing should reflect patient s renal function. Bratzler, DW., Dellinger, EP., Olsen, KM., et. al. (2013). Clinical practice guidelines for antimicrobial prophylaxis in surgery. American Journal of Health-System Pharmacists. 70:1195-283. 5
Medication Adult Dose Pediatric Dose Re-dosing Renal CDC Surgical Antibiotic Prophylaxis Guidelines Appropriate Antibiotic Prophylaxis and Surgical Site Infections 1. Select the narrowest spectrum antibiotic with equivalent efficacy and a good safety profile 2. Administer the antibiotic with equivalent efficacy for the shortest duration (24 hours) 3. Administer an antibiotic dose designed to achieve minimal inhibitory concentrations (MIC) in the serum and affected tissues 4. Achieve proper timing before incision 5. Maintain therapeutic levels (MIC) of the antibiotic throughout the operation Zanetti, G., et. al.(2001). Intraoperative redosing of cefazolin and risk for surgical site infection in cardiac surgery. Emerging Infectious Disease. Vol. 7 (5):828-831. www.nhsn.cdc.gov National Healthcare Safety Network Surgical Site Infections for 2015. GAP Analysis: Defining Our Current State A GAP analysis was performed on a sample of 40 surgical cases all exceeding 4 hours in duration performed between 6/1/15 to 7/8/15. The sample involved 9 different surgical disciplines. Data was collected on 9 different variables including: surgical procedure, surgeon, anesthesia team, initial antibiotic selection and dose, maintenance antibiotic re-dosing interval, estimated blood loss, and patient weight, renal function and allergy history. Our operative team performance was compared against the 2013 CDC Surgical Antibiotic Prophylaxis Guidelines. The success metric for maintenance antibiotic re-dosing includes the 60- minute time period comprised of the 30-minute window before and after the evidence-based recommended time. 6
GAP Analysis: Current State of Our Surgical Antibiotic Prophylaxis Program Antibiotic Selected # Of Patients # Correct Doses Per CDC # Possible Re-dosing Intervals # Correct Redosing Intervals Cefazolin 31 14 43 10 Vancomycin 2 1 2 2 Mefoxitin 3 3 11 0 Flagyl 3 3 3 1 Zosyn 3 3 9 0 Loflaxacin 1 1 1 1 Clindamycin 3 0 4 2 Current State July 1 - August 15, 2015 40 Patient Gap Analysis # Of initial Antibiotic doses or Antibiotic re-dosing interval 80 70 60 50 40 46 73 30 25 20 16 10 0 # Initial Antibiotic doses # Initial CDC consistant Antibiotic doses # Possible Antibiotic re-dosing # CDC consistent Antibiotic interval re-dosing interval GAP Analysis: Current Practice Findings Initial antibiotic dosages suggest lack of current evidence-based knowledge and recommendations. 25/46 administered antibiotics not CDC compliant Maintenance antibiotic prophylaxis performance suggests widespread lack of current evidence-based clinical guidelines. 5/40 patients received no maintenance antibiotics Only 16/73 re-dosing intervals CDC compliant Lack of provider knowledge regarding maintenance antibiotic redosing for Zosyn, Mefoxitin and Flagyl. Important variables: multiple surgical teams, extreme patient weight, renal function and surgical blood loss. Bratzler, DW., Dellinger, EP., Olsen, KM., et. al. (2013). Clinical practice guidelines for anti-microbial prophylaxis in surgery. American Journal of Health-Systems Pharmacology. 70:195-283. 7
Is Process Improvement Enough? If our project entails improving surgical antibiotic prophylaxis administration what will be it s impact on the incidence of SSI s? Donabedian s Conceptual Quality Framework Quality is assessed on the setting in which it is delivered (structure), the actual care delivered (process), or its end points (outcomes). Early approaches to surgical quality measurement and improvement focused primarily on structure and process. (Cms derived surgical care improvement project). How strong is the link between structure, process and outcomes, when it considers the role of surgical antibiotic prophylaxis and it s impact on the incidence of surgical site infections? It is possible our structural and process measures do not clearly improve outcomes due to: Measures are not related Measures are competing and multifactorial Relationships of quality measures too complex to measure Merkow, RP., et. al. (2013). Surgical quality measurement: An evolving science. JAMA Surgery. Vol. 148 (70;586-58. Process and Outcome: Our Evolving Science Regarding Antibiotic Prophylaxis and SSI s I. Initial antibiotic dose timing (IDT) within 1 hour of the surgical incision. VAN KASTEREN, MEE. et.al. (2007). Patient And Procedural Data Prospectively Gathered on 1,922 Patients Undergoing Total Hip Arthroplasty in 11 Dutch Hospitals. Finding: Administration of antibiotics (IDT) after incision associated with an increased incidence of SSI. MACKEEN, AD. et.al. (2014). Cochrane Review of 10 Studies Inclusive of 5,041 Women Undergoing C-SX Comparing AP Before Incision Versus After Cord Clamping. Findings: IDT of AP before incision decreased wound infections by 41% and endometritis by 46%. Van Kasteren, MEE., et. al. (2007). Antibiotic prophylaxis and the risk of surgical site infections following THA: Timely administration is the most important factor. Clinical Infectious Disease. (44):921-927. Mackeen, AD. et. al. (2014). Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing caesarian delivery. Cochrane Database of Systematic Reviews. Issue 12. Art. No. CD009516. AP and SSI Evolving Science Continued IDT of AP and SSI continued: Classen, DC. et. al. (1992). Prospective Monitoring in 2,847 Surgical Patients Regarding AP Timing. Findings: Trend toward higher rates of SSI with each successive hour that antibiotics were administered after the surgical incision. 2. AP regimens with short half-lives should be re-dosed on a schedule determined by the pharmacokinetic profile of each antibiotic agent Miliani, K., et. al. (2009). 7-year Surveillance Study Gathering SAP Practices in 8,029 Patients. Findings: 2.5% developed SSI, 76% optimal IDT, 19.8% not-re-dosed intra-operatively. Failure to re-dose felt to be the most important factor leading to increased SSI rates. Classen, DC., et. al. (1992). The Timing of Prophylactic Administration of Antibiotics and the Risk of Surgical Wound Infection. NEJM. Vol. 326 (5):281-286. Miliani, K. et. al. (2009). Non-Compliance with Recommendations for the Practice of Antibiotic Prophylaxis and Risk of Surgical Site Infection: Results of a Multilevel Analysis from the INCISO Surveillance Network. Journal of Antimicrobial Chemotherapy (64):1307-15. 8
AP and SSI Evolving Science Continued II AP Re-Dosing and SSI Zanetti, G., et. al. (2001). Retrospective Cohort Study Review of 1,548 Patients Undergoing Cardiac Surgery Evaluating Intra-Operative AP Re-Dosing. Findings: Case duration exceeds 240 minutes. SSI occurs 14/182 patients (7.7%) with re-dosing SSI occurs 32/200 patients (16%) without ap re-dosing. Kaiser, AB. et. al. (1983). Double Blind, Prospective, RCT of 119 Patients Undergoing Colorectal Surgery Comparing Cefoxitin to Cefazolin and Oral Erythromycin AP Regimens. Findings: 37.5% of surgeries lasting > 4 hours developed a SSI if cefoxitin was used for AP. Zanetti, G., et. al. (2001). Intra-operative re-dosing of cefazolin and risk for surgical site infection in cardiac surgery. Emerging Infectious Disease. Vol. 7. (5):828-831. Kaiser, AB., et. al. (1983). Cefoxitin versus erythromycin, neomycin, and cefazolin in colorectal surgeries. Vol. 198 (4):525-529. AP and SSE Evolving Science Continued III 3. Despite published guidelines for SAP: Compliance in the United States is imperfect. Silver, A. et. al. (1996). Timeliness Study of AP in a Retrospective Medical Record Review of 2,651 Surgical In-Patient Procedures: Demonstrated an optimal and timely prophylaxis administration in 61% of the total sample. Hedrick, TL., et. al. (2007). Implementation of a prospectively designed clinical care bundle designed to address known risk factors for SSI following elective colorectal surgery led to an increased compliance with administration of AP from 68% to 91%, and decreased SSI rates by 39%. Study addressed AP, hypothermia prevention and glycemic control. Silver, A. et. al. (1996). Timeliness and use of antimicrobial prophylaxis in selected in-patient surgical procedures. The antibiotic prophylaxis study group. American Journal of Surgery. (171):548-552. Hedrick, TL., et. al.(2007). Efficacy of protocol implementation on incidence of wound infection in colorectal operations. Journal of the American College of Surgery. Vol. 205.(3):432-438. Educational Strategic Intervention Steps Utilizing our stakeholder analysis a robust communication plan was engaged inclusive of a multi-disciplinary grand rounds presentation Information Technology IT modification of surgical antibiotic order sets Creation of an antibiotic specific pop-up alert to appear on the intra-operative anesthesia screen Cognitive Aid Laminated copies of the CDC surgical antibiotic prophylaxis guidelines placed in every operating room, surgical clinic, and the ambulatory surgical unit 9
Project Intervention Impact on Surgical Antibiotic Prophylaxis Program Antibiotic Selected # Of Patients # Correct Doses Per Cdc # Possible Redosing Intervals Cefazolin 26 26 32 32 Vancomycin 3 2 3 3 Mefoxitin 4 4 9 9 Flagyl 3 3 3 3 Ceftriaxone 3 3 3 3 Lofloxacin 3 3 3 3 Clindamycin 3 1 3 2 # Correct Redosing Intervals Post Intervention Gap Analysis Findings on Surgical Antibiotic Prophylaxis Performance % Percent CDC consistent initial Antibiotic doses or Re-dosing intervention 120% 100% 80% 60% 40% 20% 0% Comparison Graph Pre and Post Intervention Results on Surgical Antibiotic Prophylaxis Performance 55% % CDC consistent Pre-intervention Antibiotic dose 94% % CDC consistent Post intervention Antibiotic dose 27% 99% % CDC consistent % CDC consistent Pre-intervention Post intervention Antibiotic re-dosing Antibiotic re-dosing intervention intervention 10
Sustainability Plan: Maintaining Process Improvement Education Project findings shared with departments of surgery, anesthesiology, nursing and quality Project findings to be presented at the Spring Surgical Quality Colloquium Monitoring Quality department bi-annual focused reviews to assure process compliance. Variance findings shared with respective chairs and providers. Future Project strategic interventions and outcomes to be shared with institution s PSO hospital members with planned PSO educational dissemination plan. Why Was The Project So Successful? 1. Patient-Centered Goal 2. Measurable End-Points 3. Committed Project Team Members 4. Strong Evidence Base 5. Consensus-Driven Project 6. Local Information Technology Expertise 7. Excellent Clinical Staff 8. Minimal Stakeholder Barriers 9. Executive Leadership Support 10. Financial Well-Being and Reputation at Risk 11. Sense of Urgency Given Recent Poor Clinical Performance 12. Timing (The Perfect Storm) 13. Monitoring And Reporting of Performance 14. Educational Support/Expertise (TJSOPH)!!! Thank you to my wife, family, teachers, students and administrative staff at Thomas Jefferson for their patience and support Monticello Anza-Borrego State Park 11
Thank You! EVALUATION FORM For access to the evaluation form, contact Jim Lapp at jlapp@chartrrg.com Evaluation form must be completed by May 4, 2017 Your certificate will be emailed to you once program requirements are met Program Requirements: Successful completion of this program requires your attendance of the entire session and submission of an evaluation form CHART Institute, LLC is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association, an accredited approver by the American Nurses Credentialing Center s Commission on Accreditation 12