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Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Disclaimer: The findings and conclusions in this presentation are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

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Page 1: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Prevention of Clostridium difficile Infection (CDI)

Massachusetts CDI Prevention Collaborative

Carolyn Gould, MD MSCRL. Cliff McDonald, MD

Division of Healthcare Quality PromotionCenters for Disease Control and Prevention

Disclaimer: The findings and conclusions in this presentation are those of the author and do not necessarily represent the official position of the Centers for Disease Control and

Prevention.

Page 2: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Objectives Describe the impact and changing

epidemiology of C. difficile infection (CDI) Discuss the pathogenesis of CDI Review HHS Prevention Targets Discuss Core and Supplemental Strategies for

Prevention of CDI– Contact Precautions– Hand hygiene– Environmental cleaning– Diagnostic testing– Antimicrobial stewardship

Page 3: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Background: Impact

Hospital-onset: 165,000 cases, $1.3 billion in excess costs, and 9,000 deaths annually

Community-onset, healthcare-facility associated: 50,000 cases, $0.3 billion in excess costs, and 3,000 deaths annually

Nursing home-onset: 263,000 cases, $2.2 billion in excess costs, and 16,500 deaths annually

Campbell et al. Infect Control Hosp Epidemiol. 2009:30:523-33 Dubberke et al. Emerg Infect Dis. 2008;14:1031-8Dubberke et al. Clin Infect Dis. 2008;46:497-504 Elixhauser et al. HCUP Statistical Brief #50. 2008

Page 4: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Heron et al. Natl Vital Stat Rep 2009;57(14). Available at http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_14.pdf

Age-Adjusted Death Rate* for Enterocolitis Due to C. difficile, 1999–

2006

*Per 100,000 US standard population

0

0.5

1.0

1.5

2.0

2.5

1999 2003

Rate

2000 20042001 20052002 2006Year

MaleFemaleWhiteBlackEntire US population

Page 5: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Mortality due to C. difficile Infection per 100,000 population, Massachusetts

http://wonder.cdc.gov/mortSQL.html

Page 6: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Background: EpidemiologyCurrent epidemic strain of C. difficile BI/NAP1/027, toxinotype III

• Historically uncommon – epidemic since 2000 More resistant to fluoroquinolones

• Higher MICs compared to historic strains and current non-BI/NAP1 strains

More virulent• Increased toxin A and B production• Polymorphisms in binding domain of toxin B• Increased sporulation

McDonald et al. N Engl J Med. 2005;353:2433-41Warny et al. Lancet. 2005;366:1079-84

Stabler et al. J Med Micro. 2008;57:771–5Akerlund et al. J Clin Microbiol. 2008;46:1530–3

Page 7: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Sunenshine et al. Cleve Clin J Med. 2006;73:187-97

Pathogenesis of CDI

4. Toxin A & B Productionleads to colon damage +/- pseudomembrane

1. Ingestionof spores transmitted from other patients

via the hands of healthcare personnel and environment

2. Germination intogrowing (vegetative)

form

3. Altered lower intestine flora (due to antimicrobial use) allows

proliferation of C. difficile in colon

Page 8: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Background: EpidemiologyRisk Factors

Antimicrobial exposure Acquisition of C. difficile Advanced age Underlying illness Immunosuppression Tube feeds ? Gastric acid suppression

Main modifiable risk factors

Page 9: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

HHS Prevention Targets

http://www.hhs.gov/ophs/initiatives/hai/appendices.html

Metric Original HAI Elimination Metric

HAI Comparison Metric

Measurement System

National Baseline Established

National 5-Year Prevention Target

Coordinator of Measurement System

Is the Metric NQF Endorsed?

C diff 1 Case rate per patient days; administrative/ discharge data for ICD-9 CM coded C. difficile Infections

Hospitalizations with C. difficile per 1,000 patient discharges

Hospital discharge data

2008 At least 30% reduction in hospitalizations with C. difficile per 1,000 patient discharges

AHRQ or CDC No

C diff 2 C. difficile SIR CDC NHSN MDRO/CDAD Module LabID‡

2009-2010 Reduce the facility-wide healthcare facility-onset C. difficile LabID event SIR by at least 30% from baseline

CDC No

Page 10: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Prevention Strategies Core Strategies

– High levels of scientific evidence

– Demonstrated feasibility

Supplemental Strategies

– Some scientific evidence

– Variable levels of feasibility

*The Collaborative should at a minimum include core prevention strategies. Supplemental prevention strategies also may be used. Most core and supplemental strategies are based on HICPAC guidelines. Strategies that are not included in HICPAC guidelines will be noted by an asterisk (*) after the strategy. HICPAC guidelines may be found at www.cdc.gov/hicpac

Page 11: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Core Prevention Strategies

Contact Precautions for duration of diarrhea Hand hygiene in compliance with CDC/WHO Cleaning and disinfection of equipment and

environment Laboratory-based alert system for immediate

notification of positive test results Educate about CDI: HCP, housekeeping,

administration, patients, families

www.cdc.gov/ncidod/dhqp/id_CdiffFAQ_HCP.htmlDubberke et al. Infect Control Hosp Epidemiol 2008;29:S81-92

Page 12: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Supplemental Prevention Strategies

Extend use of Contact Precautions beyond duration of diarrhea (e.g., 48 hours)*

Presumptive isolation for symptomatic patients pending confirmation of CDI

Evaluate and optimize testing for CDI Implement soap and water for hand hygiene before

exiting room of a patient with CDI Implement universal glove use on units with high

CDI rates* Use sodium hypochlorite (bleach) – containing

agents for environmental cleaning Implement an antimicrobial stewardship program

* Not included in CDC/HICPAC 2007 Guideline for Isolation Precautions

Page 13: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Contact Precautions

Gloves/gowns on room entry

Private room (preferred) or cohort with dedicated commodes

Dedicated equipment Maintain for duration of

diarrhea Measure compliance

Extend use of Contact Precautions beyond duration of diarrhea

Presumptive isolation Universal glove use on

units with high CDI rates Intensify assessment of

compliance

www.cdc.gov/ncidod/dhqp/id_CdiffFAQ_HCP.htmlDubberke et al. Infect Control Hosp Epidemiol 2008;29:S81-92

Cohen et al. Infect Control Hosp Epidemiol 2010;31

Core Supplemental

Page 14: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Rationale for considering extending isolation beyond duration of diarrhea

Bobulsky et al. Clin Infect Dis 2008;46:447-50

Page 15: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Patients should meet criteria for testing and presumptive isolation >3 unformed (i.e., taking the shape of a

container) stools within 24 hours– Send specimen for testing and presumptively

isolate patient pending results– Positive predictive value of testing optimized if

focused on patients with >3 unformed stools within 24 hours

– Exception: patient with possible recurrent CDI (isolate and test following first unformed stool)

Page 16: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Rationale for considering universal glove use on units with high CDI rates

Asymptomatic carriers may have a role in

transmission (magnitude uncertain) Practical screening tests not available Still require Contact Precautions for

patients with known CDI Focus enhanced environmental cleaning

strategies and avoid shared medical equipment on such units as well

Page 17: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Riggs et al. Clin Infect Dis 2007;45:992–8

Role of asymptomatic carriers?

Page 18: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

http://www.cdc.gov/nhsn/forms/57.127_MDROMonthlyReporting_BLANK.pdf

Page 19: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Hand Hygiene

Hand hygiene based on CDC or WHO guidelines

Soap and water preferentially in outbreak or hyperendemic settings

Measure compliance

Soap and water for hand hygiene before exiting room of a patient with CDI

Intensify assessment of compliance

www.cdc.gov/ncidod/dhqp/id_CdiffFAQ_HCP.htmlDubberke et al. Infect Control Hosp Epidemiol 2008;29:S81-92

Cohen et al. Infect Control Hosp Epidemiol 2010;31

Core Supplemental

Page 20: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Hand Hygiene – Soap vs. Alcohol gel Alcohol not effective in eradicating C. difficile spores But in clinical practice, is soap and water better?

– Effect on HH adherence and transmission of other HAIs unclear

• Increased adherence with alcohol hand rub• Limited availability of sinks in many facilities

– Recent data suggesting spore adherence to skin and difficulty removing spores with soap and water

– Incremental benefit of soap and water vs. alcohol with glove use?

Ellingson K, McDonald C. Infect Control Hosp Epidemiol 2010;31:571-3

Page 21: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Boyce et al. Infect Control Hosp Epidemiol 2006;27:479-83

Page 22: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Hand Washing: Product ComparisonProduct Log10

Reduction

Tap Water 0.76

4% CHG antimicrobial hand wash 0.77

Non-antimicrobial hand wash 0.78

Non-antimicrobial body wash 0.86

0.3% triclosan antimicrobial hand wash 0.99

Heavy duty hand cleaner used in manufacturing environments

1.21*

* Only value that was statistically better than others

Edmonds, et al. Presented at: SHEA 2009; Abstract 43Johnson et al. Am J Med 1990;88:137-40

Conclusion: Spores may be difficult to eradicate even with hand washingEmphasizes need for absolute adherence with glove use

Page 23: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Environmental Cleaning

Cleaning and disinfection of equipment and environment

Consider sodium hypochlorite in outbreak or hyperendemic settings

Routinely assess adherence to protocols and adequacy of cleaning

Reassess adequacy of room cleaning and address issues

Use sodium hypochlorite (bleach) – containing agents

www.cdc.gov/ncidod/dhqp/id_CdiffFAQ_HCP.htmlDubberke et al. Infect Control Hosp Epidemiol 2008;29:S81-92

Cohen et al. Infect Control Hosp Epidemiol 2010;31

Core Supplemental

Page 24: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Environmental Cleaning Bleach can kill spores, whereas other standard

disinfectants cannot Limited data suggest cleaning with bleach (1:10 dilution

prepared fresh daily) reduces C. difficile transmission Two before-after intervention studies demonstrated

benefit of bleach cleaning in units with high endemic CDI rates

Therefore, bleach may be most effective in reducing burden where CDI is highly endemic

Mayfield et al. Clin Infect Dis 2000;31:995-1000Wilcox et al. J Hosp Infect 2003;54:109-14

Page 25: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Environmental CleaningAssess adequacy of cleaning before changing

to new cleaning product such as bleach Ensure that environmental cleaning is adequate

and high-touch surfaces are not being overlooked A fluorescent environmental marker is one

method to asses cleaning and can lead to sustained improvement in cleaning following education

The use of environmental markers is a promising method to improve cleaning in hospitals

Carling et al. Clin Infect Dis 2006;42:385-8

Page 26: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Diagnostic Testing

Laboratory-based alert system for immediate notification of positive test results

Evaluate and optimize testing for CDI

www.cdc.gov/ncidod/dhqp/id_CdiffFAQ_HCP.htmlDubberke et al. Infect Control Hosp Epidemiol 2008;29:S81-92

Cohen et al. Infect Control Hosp Epidemiol 2010;31

Core Supplemental

Page 27: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Evaluate and optimize test-ordering practices and diagnostic methods

Toxin A/B enzyme immunoassays have low sensitivities (70-80%)

Despite high specificity, poor test ordering practices (i.e. testing formed stool or repeat testing) may lead to false positives

Consider more sensitive diagnostic paradigms but apply these more judiciously

– Employ a highly sensitive screen with confirmatory test or a PCR-based molecular assay

– Restrict testing to unformed stool only– Focus testing on patients with > 3 unformed stools

within 24 hours– Require expert consultation for repeat testing within 5

days

Peterson et al. Ann Intern Med 2009;15:176-9.

Page 28: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Antimicrobial Stewardship

Along with transmission, main modifiable risk factor for CDI

40-50% of antibiotic use may be unnecessary

Clinical Infectious Diseases 2007; 44:159–77

Page 29: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Audit and feedback targeting broad-spectrum antibiotics

A prospective, controlled interrupted time-series analysis in 3 acute medical wards for the elderly

Introduced a narrow-spectrum antibiotic policy

Reinforced using feedback Reductions in targeted

antibiotics and CDI

Fowler et al. J Antimicrob Chemother 2007;59:990-5

Page 30: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of
Page 31: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Desperate Measures for Desperate Times: Restricting all Fluoroquinolones to End an Outbreak

Kallen, et al. 18th Annual Meeting of The Society for Healthcare Epidemiology of America (SHEA), April 6, 2008; Orlando, FL.

0

5

10

15

20

25

Nu

mb

er o

f C

ases

Month and Year

Beginning of outbreak period

Quinolone restriction

New housekeeping company

Quinolone restriction partially lifted

2004 2005 2006 2007

Page 32: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

0

0.5

1

1.5

2

2.5

Jan

Mar

May Ju

lSep Nov Ja

nM

arM

ay Jul

Sep Nov Jan

Mar

2005 2006 2007

Month and year

Pre-intervention6.6% increase/month (p<0.001)

Immediate effect of FQ restriction28% drop (p=0.15)

Post-intervention (P<0.006)

Time Series ModelH

O-C

DA

D c

ases

/1,0

00 p

d

Proportion of isolates that were epidemic strain decreased• 66% (43) before interventions to 44% (25) after (p=0.02)

Page 33: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Quinolone Restriction Period

Nim

ber

of

Def

ined

Dai

ly D

ose

s

2005 2006 2007Month and Year

Impact that Restricting Fluoroquinolones can Have on Reducing Unnecessary Antimicrobial Use

0

500

1000

1500

2000

2500

Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Aminoglycosides Cephalosporins (1st gen.)

Cephalosporins (2nd gen.) Cephalosporins (3rd and 4th gen.)

Quinolones Vancomycin

Piperacillin/Tazobactam Ampicillin/Sulbactam

Azithromycin Carbapenems

Aztreonam Clindamycin

Kallen, et al. 18th Annual Meeting of The Society for Healthcare Epidemiology of America (SHEA), April 6, 2008; Orlando, FL.

Page 34: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Antibiotic Stewardship Drivers and Change Package Partnership between CDC and IHI Develop a conceptual model of key

drivers for reducing inappropriate antibiotic utilization

Goal: set of recommendations for all hospitals regardless of size, acuity, setting

– Implementation tailored to needs and resources of facility

– Prototyping in pilot hospitals

Page 35: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Measurement: OutcomeCategorize Cases by location and time

of onset†

Admission Discharge

< 4 weeks 4-12 weeks

HO CO-HCFA Indeterminate CA-CDI

Time

2 d > 12 weeks

*

HO: Hospital (Healthcare)-OnsetCO-HCFA: Community-Onset , Healthcare Facility-AssociatedCA: Community-Associated

* Depending upon whether patient was discharged within previous 4 weeks, CO-HCFA vs. CA † Onset defined in NHSN LabID Event by specimen collection date

Modified from CDAD Surveillance Working Group. Infect Control Hosp Epidemiol 2007;28:140-5

Day 1 Day 4

Page 36: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Measurement: OutcomeNHSN CDAD Module

Page 37: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

http://www.cdc.gov/HAI/recoveryact/stateResources/stateResources.html

Page 38: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Evaluation Considerations Assess baseline policies and procedures

Areas to consider– Surveillance– Prevention strategies– Measurement of effect of strategies

Coordinator should track new policies/practices implemented during collaboration

Standardized questions available at: http://www.cdc.gov/HAI/recoveryact/stateResources/stateResources.html

Page 39: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

http://www.cdc.gov/HAI/recoveryact/PDF/CDI_EvalQuestions_Final_Clearedversion32910.pdf

Page 40: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Additional resources

Dubberke et al. Infect Control Hosp Epidemiol 2008;29:S81-92

CDI Checklist Example

Abbett SK et al. Infect Control Hosp Epidemiol 2009;30:1062-9

Cohen et al. Infect Control Hosp Epidemiol 2010;31

Page 41: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Example of Success: UK Experience

http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1274091661838

Page 42: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Objectives Describe the impact and changing

epidemiology of C. difficile infection (CDI) Discuss the pathogenesis of CDI Review HHS Prevention Targets Discuss Core and Supplemental Strategies for

Prevention of CDI– Contact Precautions– Hand hygiene– Environmental cleaning– Diagnostic testing– Antimicrobial stewardship

Page 43: Prevention of Clostridium difficile Infection (CDI) Massachusetts CDI Prevention Collaborative Carolyn Gould, MD MSCR L. Cliff McDonald, MD Division of

Thank you!

[email protected]