IHI Expedition Reducing Clostridium difficile Infections Session 2: Rapid Detection and Isolation

Transcription

1 July 9, 2014 These presenters have nothing to disclose IHI Expedition Reducing Clostridium difficile Infections Session 2: Rapid Detection and Isolation Brian Koll, MD Cliff McDonald, MD Diane Jacobsen MPH, CPHQ Today s Host 2 Morgen Palfrey, Project Coordinator, Institute for Healthcare Improvement, is the current coordinator for web- based Expeditions. She also contributes to the IHI Leadership Alliance, the Always Project, and works with Strategic Partners in Singapore. Morgen is a member of Work- Life Wellness Team and Diversity and Inclusion Council at IHI, where she and fellow staff members develop strategies for improving the mind and body. Morgen graduated from the University of Florida in Gainesville, FL where she received her Bachelor of Arts degree in Political Science with a concentration in Public Administration. 1

2 Audio Broadcast 3 You will see a box in the top left hand corner labeled Audio broadcast. If you are able to listen to the program using the speakers on your computer, you have connected successfully. Phone Connection (Preferred) 4 To join by phone: 1) Click the button on the right hand side of the screen. 2) A pop-up box will appear with call in information. 3) Please dial the phone number, the event number and your attendee ID to connect correctly. 2

3 Audio Broadcast vs. Phone Connection If you using the audio broadcast (through your computer) you will not be able to speak during the WebEx to ask question. All questions will need to come through the chat. 5 If you are using the phone connection (through your telephone) you will be able to raise your hand, be unmuted, and ask questions during the session. Phone connection is preferred if you have access to a phone. WebEx Quick Reference Welcome to today s session! Please use chat to All Participants for questions For technology issues only, please chat to Host WebEx Technical Support: Dial-in Info: Communicate / Join Teleconference (in menu) Raise your hand Select Chat recipient Enter Text 6 3

4 When Chatting 7 Please send your message to All Participants Expedition Director Diane Jacobsen, MPH, CPHQ, Director, Institute for Healthcare Improvement (IHI) is currently directing the CDC/IHI Antibiotic Stewardship Initiative, NSLIJ/IHI Reducing Sepsis Mortality Collaborative. Ms. Jacobsen served as IHI content lead and improvement advisor for the California Healthcare-Associated Infection Prevention Initiative (CHAIPI) and directed Expeditions on Antibiotic Stewardship, Preventing CA-UTIs, Reducing C.difficle Infections, Sepsis, Stroke Care and Patient Flow. She served as faculty for IHI s 100,000 Lives and 5 Million Lives Campaign and directed improvement collaboratives on Sepsis Mortality, Patient Flow, Surgical Complications, Reducing Hospital Mortality Rates (HSMR) and co-directed IHI s Spread Initiative. She is an epidemiologist with experience in quality improvement, risk management, and infection control in specialty, academic, and community hospitals. A graduate of the University of Wisconsin, she earned her master s degree in Public Health- Epidemiology. 8 4

5 Today s Agenda 9 Introductions Action Period Assignment Debrief Rapid Detection & Isolation Action Period Assignment Expedition Objectives 10 At the end of this Expedition, participants will be able to: Explain the impact of the increasing incidence and severity of C. difficile on hospitals Discuss key approaches to preventing the spread of C. difficile in the hospital setting Identify and begin improving at least one key process for impacting C. difficile in their hospital 5

6 Schedule of Calls Session 1 Making the Case for Reducing Clostridium difficile Infections (CDI) Date: Wednesday, June 25, 2:00 3:30 PM ET Session 2 Rapid Detection and Isolation Date: Wednesday, July 9, 2:00 3:00 PM ET Session 3 Symptom Recognition, Precautions, and the Role of the Environment Date: Wednesday, July 23, 2:00 3:00 PM ET Session 4 Antibiotic Stewardship Date: Wednesday, August 6, 2:00 3:00 PM ET Session 5 The Role of Leadership Date: Wednesday, August 20, 2:00 3:00 PM ET Session 6 Transitions and Long- term Care Date: Wednesday, September 3, 2:00 3:00 PM ET 11 Action Period Assignment Debrief 12 Assess your current process for identifying patients with C diff. Does it include: - A flagging system for patients previously hospitalized with C diff? - Prompt implementation of isolation precautions for patients suspected of C diff, pending laboratory confirmation? - Prompt notification from the laboratory of results of testing? Assess this process by interviewing a bedside nurse on a unit caring for C diff patient(s) What did you learn? Insights? Surprises? 6

7 Faculty Brian Koll, MD, FACP, FIDSA, Executive Director for Infection Prevention, the Mount Sinai Health System, New York, NY, is a nationally-renowned and award-winning infection prevention expert. He has been featured on CBC Evening News for successful efforts to reduce central line associated bloodstream infections, on World News Tonight for successful efforts to control C. difficile, and in a national public service announcement regarding this disease by the Peggy Lillis Memorial Foundation. 13 Faculty 14 Cliff McDonald, MD, is a former officer in the Epidemic Intelligence Service and is currently the Senior Advisor for Science in the Division of Healthcare Quality Promotion at the CDC. This division seeks to protect patients and healthcare personnel and promotes safety and quality in healthcare delivery systems. Examples of activities include programs for addressing antimicrobial resistance, healthcare-associated infections, and other adverse events affecting patients and healthcare workers. Dr. McDonald is an expert in Clostridium difficile, an antibiotic resistant bacterium. Dr. McDonald graduated from Northwestern University Medical School in Chicago. He completed his Internal Medicine Residency at Michigan State and an Infectious Diseases Fellowship at the University of South Alabama, following which he completed a fellowship in Medical Microbiology at Duke University. Past positions have included Associate Investigator at the National Health Research Institutes in Taiwan, where he helped develop an island-wide surveillance system for antimicrobial resistance, and Assistant Professor in the Division of Infectious Diseases at the University of Louisville, where he worked as a hospital epidemiologist in infection control. He is the author or co-author of over 100 peer-reviewed publications, is a Fellow of the American College of Physicians and the Society for Healthcare Epidemiology of America, and a member of the Infectious Diseases Society of America and American Society for Microbiology. Areas of Expertise include: C. Difficile, Drug Resistant Pathogens, and Healthcare Associated Infections To request an interview, call CDC s Division of Media Relations at (404) , or us at media@cdc.gov. 7

8 Changing from EIA to GDH PCR Testing for CDI Brian Koll, MD, FACP, FIDSA Executive Director, Infection Control Mount Sinai Health System Professor of Medicine Icahn School of Medicine Acknowledgements Research Fellow Jennifer Leoniak DO Statistical Analysis David Lucido, PhD Data Collection Jonathan Martin, MD Rie Ueno, MD Aaron Etra, MD Microbiologic Data William Riley, PhD Pharmaceutical Data Tom Jodlowski, PhD 16 8

9 BACKGROUND Clostridium difficile (CDI) is the most commonly recognized cause of infectious diarrhea in health care settings and is one of the most common healthcare associated infections The goals of testing patients with clinical significant diarrhea (CSD) are to identify cases of Clostridium difficile infection. Cohen, S.H., Gerding, D.N., Johnson, S., Kelly, C.P., Loo, V.G., McDonald, L.C., Pepin, J., Wilcox, M.H., Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infection Control and Hospital Epidemiology 2010; 31 (5): BACKGROUND: Testing Algorithms One of the ways hospitals can decrease CDI incidence and decrease length of stay is through improved testing protocols, which can decrease spread of CDI through increased detection and more rapid implementation of infection control measures. Diagnostic testing for CDI has undergone a paradigm shift in recent years from immunoassay for toxins A and B, to the newer molecular assays or combination algorithms 18 9

10 BACKGROUND: Performance for Testing Strategies Performance Characteristics: Results for Different Testing Strategies Assay(s) Sensitivity % Specificity % Approx. Cost of Testing Materials at our Facility ($) Toxin A/B alone GDH and toxin A/B EIA GDH/toxin A/B EIA and molecular Molecular alone GDH assay had lower sensitivities with specimens positive for ribotypes other than BACKGROUND: FDA APPROVED PCR Food and Drug Administration-Approved Polymerase Chain Reaction Assays for Clostridium difficile Gene Target (s) Time (min) tcdb tcdb tcdb +/- tcdc Binary toxin tcdb tcda tcdb tcdc tdcc gene is found in NAP1/BI/O27 strains and is associated with increased toxin production 20 10

11 Stool Sample GDH Positive Toxin Positive TRUE POSITIVE GDH Positive Toxin Negative Possible CDI GDH Negative Toxin Negative TRUE NEGATIVE PCR for Toxin Positive Negative CDI Protocol When CDI test ordered, patient automatically placed on contact precautions When patient placed on oral metronidazole or oral vancomycin, review for need for contact precautions CDI result treated as critical value with results called to the patient care area Education of healthcare providers Frequency of testing Interpretation of results 22 11

12 Results of CDI Testing 23 Results of CDI Testing 24 12

13 Results of CDI Testing 25 Results of CDI Testing 26 13

14 New York State DOH Hospital Acquired Infections Report Contact Precautions Traffic Light PATIENTS ON ISOLATION PRECAUTIONS Patient MR# Room Source Organism Precautions F 6 5L02A Blood MDR Acinetobacter / VRE Strict Contact March 7, 2013 G 7 5L03A Urine / Wound MDR Klebsiella / VRE Strict Contact H 8 5L03B Blood MDR Acinetobacter / VRE Strict Contact I 9 5L03C Blood / Nasal MDR Klebsiella / MRSA Strict Contact J 10 5L04C Wound MDR Klebsiella / MDR Pseudomonas / VRE/ MDR Acinetobacter Strict Contact M 13 SICU10 Blood / Wound MRSA Contact N 14 SICU01 Abscess VRE Contact O 15 11L16P Wound MRSA / C. difficile Contact P 16 11L12B Stool MRSA Contact U 21 5L01B Nasal MRSA Contact V 22 5L02B Sputum MRSA Contact W 23 MICU07 C. difficile Contact X 24 11L12B C. difficile Contact Y 25 10D05S C. difficile Contact 14

15 Contact Precautions Traffic Light Patients with Multi-Drug Resistant (MDR) or Pan-Drug Resistant (PDR) Acinetobacter, Klebsiella, etc. should be on strict contact precautions and cohorted. Staff caring for these patients should not care for other non-infected patients. Equipment used on these patients should not be used on non-infected patients. Care givers should wear gowns and gloves when entering the room to see these patients. Masks should be worn if suctioning is necessary. Rooms must be terminally cleaned after a patient with this organism is discharged and cleared by Infection Control before a new patient is admitted. Patients with Clostridium difficile should be cohorted. Upon discharge, the room must be terminally cleaned using a 1:10 bleach solution after initial cleaning with the hospital approved germicide. While a patient is in the hospital a 1:10 bleach solution should be used for daily cleaning as needed. CDI Bundle Compliance Ownership by the Unit 15

16 New York State DOH Hospital Acquired Infections Report 2012 New York State DOH Hospital Acquired Infections Report

17 Patient Demographics Patient Demographic EIA n = 331 GDH PCR n = 495 p Value Age (mean) Female 175 (53) 273 (55) Race White 175 (53) 257 (52) Black 56 (17) 94 (19) Hispanic 46 (14) 64 (13) Asian 30 (9) 35 (7) Other 20 (6) 46 (8) Charlson Comorbidity Index (mean) 13 (4) 20 (4) Prior Hospitalization 113 (34) 173 (35) CDI positive patients 31(9) 37(7) Patient Demographics Severity in Positive Patients EIA (n=31) GDH PCR (n=37) p Value Mild to Moderate Severe Severe Complicated

18 TESTING EIA (n=331) GDH PCR (n=495) p Value Total Test Cost ($) 10 (5-30) 22 <0.000 Mean Days to Final Test Result 3 (1-13) 2 (1-8) <0.000 TESTING (CDI POSITIVE PATIENTS) EIA (n=31) GDH PCR (n=37) p Value Total Test Cost ($) <0.000 Mean Days to Final Test Result 3 (1-8) 3 (1-6) Number of Tests Performed Total EIA Tests Performed n = 635 Quantity of EIA Tests Ordered During a Single Episode Total GDH PCR Performed n = 604 Number of GDH PCR Tests Ordered During a Single Episode

19 RESULTS FOR PCR NUMBER OF PCR TESTS PERFORMED IN A SINGLE EPISODE Results Number Positive 26 (45%) Negative 32 (55%) Number of Hospital Days to PCR Results (12%) out of 495 possible CDI 37 RESULTS FOR ALL PATIENTS EIA (n=331) GDH PCR (n=495) p Value Length of Stay (mean) < d Readmission 86 (26) 134 (27) Total Test Costs ($) <0.000 Mean CDI Antibiotic Cost ($) Death within 30d

20 RESULTS FOR CDI POSITIVE PATIENTS EIA (n=31) GDH PCR (n=37) p Value Mean Length of Stay <0.014 Escalation of Care Mean Total Test Costs ($) <0.000 Mean CD Antibiotic Cost ($) Recurrence within 30 days Death within 30d 9 2 <0.000 EIA to GDH PCR for CDI The amount of CDI detected was not significantly different between the two testing methodologies 12% required confirmatory testing by PCR Decreased time to result by one day During time period GDH PCR in place Decrease in length of stay Decrease in antibiotic costs Decrease in escalation of care Decrease in all cause 30 day mortality Increase in cost of testing 20

21 EIA to GDH PCR for CDI During time period GDH PCR in place Decrease in length of stay Decrease in antibiotic costs Increase in cost of testing Costs during EIA = $1,705,090 Costs during GDH PCR = $1,099,440 Reduction in costs overall = $605,650 Questions/Discussion 42 Raise your hand Use the Chat 21

22 Clostridium difficile Infection: Rapid Detection and Isolation Carolyn Gould, MD, MSCR L. Clifford McDonald, MD, FACP, SHEA Division of Healthcare Quality Promotion Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion Vital Signs: 6 Key Components of Prevention Prescribe and use antibiotics carefully Focus on an early and reliable diagnosis Isolate patients immediately Wear gloves and gowns for all contact with patient and patient care environment Assure adequate cleaning of the patient care environment, augment with EPA-registered C. difficile sporicidal disinfectant Notify facilities upon patient transfer Rapid detection and isolation 22

23 Components of Rapid Detection and Isolation Screen patients for new-onset diarrhea on admission and on a regular basis. Facilitate early testing. Consider nurse-driven protocols. Pair testing with order for Contact Precautions. Use more sensitive testing methods. Optimizing Testing Enzyme immunoassay (EIA) for toxin sensitivity 48%- 67% More sensitive tests: Nucleic-acid amplification tests (NAAT) Polymerase chain reaction (PCR) Loop-mediated amplification (LAMP) GDH + toxin testing of positive specimens GDH less sensitive (79%-98%) compared to NAAT or toxigenic culture in a recent meta-analysis Tenover FC, Novak-Weekley S, Woods CW, et al. J Clin Microbiol 2010; 48: Tenover et al. J Mol Diagn 2011;13: Peterson et al. Clin Infect Dis 2007;45: Shetty et al. J Hosp Infect 2011;77:1-6 23

24 Typical Diagnostic Algorithm for Detection of Toxigenic C. difficile in Stool Specimens Kufelnicka and Kirn T J Clin Infect Dis. 2011;52: FDA-Approved Commercial NAAT Assays 5 currently 4 use PCR to detect toxin B gene (tcdb) 1 uses LAMP to detect toxin A gene (tcda) Only LAMP assay specifically cleared for testing symptomatic children 1-2 years of age Although some C. difficile strains are toxin A negative, vestigial tcda sequences still present in such strains are reportedly sufficient to provide a signal Tenover et al. J Mol Diagn 2011;13:

25 First and Foremost For any testing method, you need a favorable pretest probability of disease for optimal performance Diagnostic accuracy improves with increasing prevalence of disease in the population tested That means testing appropriately: Watery/unformed stool (conforms to shape of container) At least 3 unformed stools in 24 hours Avoidance of repeat testing, tests of cure Lab stool rejection policies important Making Early and Accurate Diagnosis a Reality To Realize Benefit of NAAT Need a Rational Testing Strategy Meta-analysis of 19 studies, 7392 samples Mean sensitivity: 90% Mean specificity: 96% a 15-20% testing prevalence with a NAAT may be more achievable than a 8-12% prevalence with an EIA --LC McDonald Deshpande et al. Clinical Infectious Diseases 2011;53(7):e81 e90 25

26 Results of Repeat PCR Tests Following a Negative Result. Luo R F and Banaei N J. Clin. Microbiol. 2010;48: How Will Use of NAAT Affect CDI Incidence Rates? Source Change in testing % Increase in CDI incidence 3 states in CDC s Emerging Infections Program CDI surveillance EIA PCR 43% - 67% Multi-hospital EIA PCR 56% Single center EIA PCR 57% Single center EIA PCR 110% Single center GDH+EIA+CCNA PCR 50% Single center EIA GDH+PCR 97% Single center GDH+EIA GDH+EIA+PCR 70% Gould et al. Clin Infect Dis 2013 Longtin et al. Clin Infect Dis 2012; advanced access Moehring et al ICHE 2013;34: de Jong et al. Eur J Clin Microbiol Infect Dis 2012;31: Goldenberg SD. Infect Control Hosp Epidemiol 2011;32: Fong et al. Infect Control Hosp Epidemiol 2011;32: Williamson et al. Am J Infect Control 2012; in press 26

27 NHSN CDI Risk Adjusted SIR Accounts for More Sensitive Testing Variables from Final Model to be included for Risk Adjustment in SIR Calculation Factor Intercept Description Facility Bed Size > 245 Teaching Type CDI Test Type Prevalence Major Graduate Limited & Non NAAT (PCR) EIA All Other Continuous (no CO-HCFA) Data Sources and Submission CDI test type, facility bed size, and teaching type are collected on the required Annual Facility Survey. The survey is completed after the end of each year for accuracy in describing a full year s worth of data. Potential Benefits of More Sensitive Testing Fewer isolation days for negative patients Fewer repetitive tests performed (46% at one institution with restriction rules in place) In theory, earlier treatment initiation, reduced complications, and improved infection control Gould et al. CID 2013;57:1304 Moehring et al. ICHE 2013;34: Loo VG, Frenette C. Presented at ICAAC Abstract D-1273 Morgan M, Grein J, Ochner M, Hoang H, Jin A, Murthy R. Presented at ICAAC 2011 Belmares J, Pua H, Schreckenberger P, Parada J. [abstract 150]. Presented at SHEA 2011 Annual Scientific Meeting, 1 4 April, 2011; Dallas, TX Goldenber g SA et al. ICHE

28 Early Detection of CDI: Importance of Inter-Facility Communication Hospital Post-acute care Long-term acute care Nursing home/snf Home health Hospice 28

29 Post Symptomatic CDI Carriage: Particularly Contagious Asymptomatic Carriers? Sethi AK et al. Infect Control Hosp Epidemiol 2010; 31:

30 Thank you! Questions? For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Place Descriptor Here 30

31 Questions? 61 Raise your hand Use the Chat Action Period Assignment 62 Rapid detection and precautions for C diff test a process: To expedite patients being placed on contact precautions when C diff is suspected or confirmed - Test a flag, prompt, etc. to automatically initiate contact precaution when CDI test is ordered. (one unit, one nurse/unit clerk, refine based on initial test) - Test a process to review patient placed on oral metronidazole or oral vancomycin, for need for contact precautions (one unit, one pharmacist/nurse, one day on MDR s refine based on initial test) - Test a process to enhance STAT reporting of CDI, ie: critical value (one unit, one week, partner with laboratory refine based on initial test) 31

32 Expedition Communications 63 Listserv for session communications: To add colleagues, us at Pose questions, share resources, discuss barriers or successes Next Session 64 Session 3: Symptom Recognition, Precautions, and the Role of the Environment Wednesday, July 23 rd, 2:00 PM 3:00 PM ET Faculty: Brian Koll MD & Cliff McDonald MD 32