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Hospital Wide Roll-Out of Antimicrobial Stewardship

17. november 2014 oppdatert av: Sunnybrook Health Sciences Centre

Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial

Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

19220

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

All patients admitted to the medical/surgical services will be included in statistical analysis of program evaluation. The inclusion/exclusion criteria below, just define who receives the antibiotic stewardship intervention on each service.

Inclusion Criteria:

  • admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery
  • receiving 3rd or 10th day of treatment with one of the following antibiotics:
  • ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin

Exclusion Criteria:

  • patient being followed by the infectious diseases consult service

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Antibiotic stewardship intervention
Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
Annen: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.
Ingen inngripen: Control
The pre-intervention period will serve as the control period on each medical and surgical service. The cross-over is uni-directional from control to intervention; all services receive the intervention by the end of the study. This is a stepped wedge design. The order of roll-out is randomized.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
Tidsramme: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
  • Targeted broadspectrum antibiotics include third generation cephalosporins (ceftriaxone, ceftazidime), beta-lactam beta-lactamase inhibitors (piperacillin-tazobactam), fluoroquinolones (ciprofloxacin, levofloxacin), carbapenems (ertapenem and meropenem), and glycopeptides (vancomycin)
  • DOTs are defined as the number of unique antibiotic agents prescribed each day (regardless of dose)
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)
Tidsramme: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
-Definition as per primary outcome, but can include any antibiotic (not just those broadspectrum agents targeted by the intervention)
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Costs of antibiotic therapy ($) per patient day
Tidsramme: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Based on acquisition costs for each agent.
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Hospital-acquired Clostridium difficile infection.
Tidsramme: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Cases of Clostridium difficile infection deemed to have been acquired during the current hospital stay by prospective Infection Prevention & Control surveillance team.
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Antibiotic susceptibility of gram negative bacterial isolates
Tidsramme: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sunnybrook Health Sciences Centre

Samarbeidspartnere

Ontario Ministry of Health and Long Term Care

Etterforskere

  • Hovedetterforsker: Nick Daneman, Sunnybrook Health Sciences Centre

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2010

Primær fullføring (Faktiske)

1. april 2012

Studiet fullført (Faktiske)

1. april 2012

Datoer for studieregistrering

Først innsendt

13. april 2012

Først innsendt som oppfylte QC-kriteriene

26. april 2012

Først lagt ut (Anslag)

30. april 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. november 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. november 2014

Sist bekreftet

1. november 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 416-2009

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