Hospital Wide Roll-Out of Antimicrobial Stewardship
17 november 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
19220
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Antibiotic stewardship intervention
Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
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See primary outcome for list of targeted drugs.
See citations for previous publications describing the intervention.
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Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
Tidsram: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)
Tidsram: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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-Definition as per primary outcome, but can include any antibiotic (not just those broadspectrum agents targeted by the intervention)
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patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Costs of antibiotic therapy ($) per patient day
Tidsram: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Based on acquisition costs for each agent.
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patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Hospital-acquired Clostridium difficile infection.
Tidsram: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Cases of Clostridium difficile infection deemed to have been acquired during the current hospital stay by prospective Infection Prevention & Control surveillance team.
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patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Antibiotic susceptibility of gram negative bacterial isolates
Tidsram: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Nick Daneman, Sunnybrook Health Sciences Centre
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Elligsen M, Walker SA, Simor A, Daneman N. Prospective audit and feedback of antimicrobial stewardship in critical care: program implementation, experience, and challenges. Can J Hosp Pharm. 2012 Jan;65(1):31-6. doi: 10.4212/cjhp.v65i1.1101. No abstract available.
- Elligsen M, Walker SA, Pinto R, Simor A, Mubareka S, Rachlis A, Allen V, Daneman N. Audit and feedback to reduce broad-spectrum antibiotic use among intensive care unit patients: a controlled interrupted time series analysis. Infect Control Hosp Epidemiol. 2012 Apr;33(4):354-61. doi: 10.1086/664757.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2010
Primärt slutförande (Faktisk)
1 april 2012
Avslutad studie (Faktisk)
1 april 2012
Studieregistreringsdatum
Först inskickad
13 april 2012
Först inskickad som uppfyllde QC-kriterierna
26 april 2012
Första postat (Uppskatta)
30 april 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 november 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 november 2014
Senast verifierad
1 november 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 416-2009
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