Journey to Decreasing Clostridium Difficile and the Unexpected Twist. Jackie Morton, Infection Prevention Cortney Swiggart, Medication Safety Officer

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1 Journey to Decreasing Clostridium Difficile and the Unexpected Twist Jackie Morton, Infection Prevention Cortney Swiggart, Medication Safety Officer 4/13/2018

2 Objectives Discuss the organism and clinical symptoms of Clostridium difficile (C. diff) Discuss measures for prevention Discuss treatment options utilized for treatment of C. diff

3 Clostridium difficile (C. diff) What is it? C. difficile is a spore-forming, grampositive anaerobic bacillus. It is a common cause of antibiotic associated diarrhea in hospitalized patients. It can cause colitis and other serious conditions such as pseudomembranous colitis, toxic megacolon, bowel perforation, sepsis, and death. It is spread through feces Image: Centers for Disease Control and Prevention/ADAM.

4 Clostridium difficile (C. diff) Signs and Symptoms Watery diarrhea - usually frequent and often uncontrollable Fever Abdominal tenderness Loss of appetite Pain or cramping in abdomen

5 Outcomes Associated with Clostridium Difficile Increased LOS 3-6 days Increased cost $3,000-15,400 Twice as likely to be discharged to long term care Attributable mortality 5%-10% Estimated 14,000-20,000 US deaths per year

6 Journey to Decrease C. Difficile Antibiotic Stewardship Appropriate Testing Environment al Decreasing C. Difficile Risk Assessment Policiy/Educat ion

7 1.4 CDIFF SIR Median Decile Q1

8 Patients Harmed C. Difficile CDIFF Pts Harmed Projection based 2018Q1

9 Antimicrobial Stewardship The optimal selection, dosage, and duration of antimicrobial treatment that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance Mayo Clin Proc. Nov 2011; 86(11):

10 Benefits of Antimicrobial Stewardship Improve quality of care Optimize treatment Reduce adverse events Enhance patient safety Fewer treatment failures Decrease rates of resistant organisms and C.diff infections Cost Savings Hospital Patient

11 CDC Core Elements Leadership commitment Accountability Drug Expertise Action Tracking Reporting Education

12 Antimicrobial Stewardship ID physician Information technology Pharmacist Laboratory Antimicrobial Stewardship Infection Prevention Epidemiology Microbiology

13 Initiatives associated with reduced C.diff Formulary changes, restrictions, preauthorizations Prospective audit and feedback Protocols or algorithms for specific infections Use of technology Education

14 Initiatives at MLH Pharmacokinetic drug monitoring Renal dose adjustment Automatic 7 day stop on all Antibiotics (Adults) Automatic IV-to-PO interchange Antibiotic Restriction Restricted to ID physicians Restricted to certain indications Electronic forms must be completed

15 Antibiotic Restriction Form

16 Clinical Surveillance System Tracks antibiotic utilization Redundant betalactam therapy Redundant anaerobic therapy Stores intervention data Provides stewardship alerts Bug-Drug mismatch Poly-antimicrobial De-escalation IV to PO conversion

17 Clinical Surveillance System Challenges Additional system to log into One time orders and On-Call orders affect accuracy Difficult to validate antibiotic utilization data Benefits Ties interventions to a dollar amount Reports can be exported In ,000 interventions reported with cost savings of 3 million dollars

18 Clinical Indication Suspected/Known Indication List: Prophylaxis Bacteremia Bone/Joint infection CNS infection Gastrointestinal infection Febrile neutropenia Intra-abdominal infection Upper respiratory tract infection Lower respiratory tract infection Sepsis (unclear source) Skin/Soft tissue infection Urinary tract infection Other (Free text box)

19 Antibiotic Indication Required Challenges Concern from prescribers List is not all inclusive Use of other Benefits Allows dose evaluation by pharmacy based on indication Easier to identify appropriate length of therapy

20 Antibiotic Time Out Pop-up alert to physicians Who does it fire to? When does it fire? What if there are multiple antibiotics? Pilot performed Smart Zone alert Viewable by all physicians Doesn t require action Pharmacist driven Task fires to pharmacist Pharmacist discusses on rounds Form is completed

21 Limited case-control study Collect data on C.diff patients and compare with a control group Review Odds Ratio and overall use to determine association with c. diff Identify antibiotics most associated with C.diff infections in your organization Currently undergoing this process Target your stewardship interventions around those antibiotics

22 Major Overall Challenges Time Data Resources

23 C. Difficile and the Environment

24 C. Difficile and the Environment

25 C. Difficile Risks Assessment 80% 70% 67% 62% 60% 50% 46% 49% 53% 40% 41% 30% 25% 27% 27% 29% 30% 20% 10% 0%

26 Clostridium Difficile Patients and Assesment 70% 60% 50% 40% 49% 61% 30% 20% 10% 0% 22% HO b/c delayed test 26% Tested for Cure On Laxatives No Symptoms Symptoms diarrhea (3 or more loose stools in 24 hours) and/or WBC > 12,000 Fever, Abdominal pain or tenderness

27 Testing Per Guidelines ORDERS APPROPRIATE TESTING INAPPROPRIATE TESTING INFECTION PREVENTION Physician directed ONLY Watery/loose stools Patient has no Diarrhea (do not send test) Contact Isolation gloves/gown every time Lab Refuses formed stool samples 3 watery/loose stools in 24 hours not otherwise explained Formed stool or sample does not conform to cup Glove use and ABHR for healthcare workers Stool sample should conform to cup Test for cure Use of soap and water for patients and family hand hygiene Routine screening Use Disinfectant w/c-diff spore claim

28 Report of Pending C. Difficile Orders Available Patient name Unit location of order Ordering Physician Laxatives History of C. Difficile Last documented stool description Report available through MOLLI and/or Cerner >P00 Explorer Menu>C. Difficile Laxative Report>select facility and dates>execute

29 Automatic Cancellation Any C. Diff order on hospital day one auto-cancelled at midnight on hospital day 3 Any C. Diff order on hospital day 2 or after should be cancelled in 48 hours

30 Inappropriate Testing Laxatives in past 72H One loose stool or absence of diarrhea (unless ileus suspected) Absence of diarrhea Formed stool Testing without MD order Test of cure and retesting* Positive C. Diff result in the past 28 days (will shed spore for weeks) Rectal washout Less than 2 years old *NOTE: Most patients who are clinically cured with treatment will continue to have toxigenic C. difficile in their stool for multiple weeks test of cure should not be conducted if a patient is being transferred to another healthcare facility.

31 C. Difficile Order Alert Keeping in mind there is a high incidence of asymptomatic carriage of C. Difficile, order Clostridium difficile assay only if the patient: has received antibiotics within the preceding month, has diarrhea (3 or >loose stools in 24 hours or watery diarrhea) and check one or more: WBC > 12,000 (unless neutropenic) Fever Abdominal pain or tenderness Not Appropriate Testing: Laxatives in past 72H One loose stool or absence of diarrhea (unless ileus suspected) Absence of diarrhea and/or formed stool Testing without MD order Test of cure Absence of diarrhea and/or formed stool Positive C. Diff result in the past 28 days Rectal washout Less than 2 years old

32 C. Difficile Alert with HX of Laxatives Your patient has received laxatives and, as expected, has loose stools. Keeping in mind there is a high incidence of asymptomatic carriage of C. Difficile, order Clostridium difficile assay only if the patient: has received antibiotics within the preceding month, and has diarrhea (3 or >loose stools in 24 hours or watery diarrhea) and check one or more: WBC > 12,000 (unless neutropenic) Fever Abdominal pain or tenderness Not Appropriate Testing: Laxatives in past 72H One loose stool or absence of diarrhea (unless ileus suspected) Absence of diarrhea and/or formed stool Testing without MD order Test of cure Positive C. Diff result in the past 28 days Rectal washout Less than 2 years old

33 Primary Indications for FMT Prevent further clinical deterioration due to severity of the patient s CDI. Recurrent or relapsing CDI defined as at least three episodes of mild to moderate CDI: and Failure of a 6- to 8-week taper with Vancomycin with or without an alternative antibiotic. 4/13/2018

34 Fecal Microbiota Transplant (FMT) FMT shown to cure over 90% of the most refractory C. difficile cases that had previously failed standard antibiotic therapy Special consent needed investigational therapy potential risks Openbiome provides screened, filtered, and frozen material ready for clinical use. Donors include young researchers and scientists within the MIT, Harvard, and Tufts communities and professionals from the Tufts University area. 4/13/2018

35 Thank you! Cortney Swiggart Jackie Morton,