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Computerized Antibiotic Stewardship Study (COMPASS)

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ClinicalTrials.gov Identifier: NCT03120975
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
Swiss National Science Foundation
University of Geneva, Switzerland
Ente Ospedaliero Cantonale, Ticino, Switzerland
Information provided by (Responsible Party):
Benedikt Huttner, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE September 3, 2018
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Days of therapy (DOT)/admission [ Time Frame: 12 months ]
Overall days of therapy of antibiotics per admission on the ward level
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
DOT/admission [ Time Frame: 24 months (12 month before intervention and during intervention) ]
Overall days of therapy per admission on the ward level
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Days of therapy(DOT)/100 patient days [ Time Frame: 12 months ]
    Overall days of therapy per 100 patient days (PD) on the ward level
  • Defined daily doses (DDD)/100 patient days (PD) and per admission [ Time Frame: 12 months ]
    Overall defined daily doses per 100 patient days and admission on the ward level
  • Antimicrobial days (AD) per 100 PD and per admission [ Time Frame: 12 months ]
    Length of therapy per 100 PD and per admission
  • Days per treatment period overall [ Time Frame: 12 months ]
    Overall days per treatment period. A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
  • 30 day-mortality [ Time Frame: 12 months ]
    All cause 30 day-mortality
  • In-hospital mortality [ Time Frame: 12 months ]
    All-cause in-hospital mortality
  • Hospital readmission within 30 days of discharge [ Time Frame: 12 months ]
    Unplanned hospital readmission within 30 days of discharge
  • Hospital length of stay (LOS) [ Time Frame: 12 months ]
    Hospital length of stay
  • ICU transfer [ Time Frame: 12 months ]
    % of admissions transferred to ICU after initial non-ICU admission
  • Guideline compliance [ Time Frame: 12 months ]
    Proportion of patients treated in compliance with facility-based guideline
  • De-escalation [ Time Frame: 12 months ]
    Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
  • IV-oral switch [ Time Frame: 12 months ]
    Proportion of patients converted from intravenous to oral therapy between days 4 and 7
  • appropriate diagnostic exams [ Time Frame: 12 months ]
    proportion of patients with appropriate diagnostic exams
  • Incidence of Clostridium difficile infections (CDI) [ Time Frame: 12 months ]
    Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission
  • Incidence of multidrug-resistant organisms (MDRO) [ Time Frame: 12 months ]
    Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 PD and admissions
  • User satisfaction [ Time Frame: 12 months ]
    User satisfaction with the system
  • Costs of administered antimicrobials [ Time Frame: 12 months ]
    Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
  • costs of the intervention [ Time Frame: 12 months ]
    total costs of the intervention
  • number of infectious diseases consultations [ Time Frame: 12 months ]
    proportion of patients with infectious diseases consultation
  • Days per treatment period for community acquired pneumonia [ Time Frame: 12 months ]
    A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
  • Days per treatment period for upper urinary tract infection [ Time Frame: 12 months ]
    A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • DOT/1000 patient days [ Time Frame: 12 months (intervention period)24 months (12 month before intervention and during intervention) ]
    Overall days of therapy per 1000 patient-days on the ward level
  • DDD/1000 patient days and per amdission [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    Overall defined daily doses per 1000 patient-days and admission on the ward level
  • Antibiotic free PD [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    Antibiotic fee patient-days per 1000 PD and per admission
  • Number of admission exposed to antibiotics [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    Number of admission exposed to at least 1 dose of systemic antibiotics / total number of admision
  • Number of treatment coruses [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    Number of antibiotic treatment courses per admission exposed to at least 1 systemtic antibiotics
  • All-cause in-hospital mortality [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    All-cause in-hospital mortality
  • Hospital readmission within 30 days of discharge [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    Hospital readmission within 30 days of discharge
  • Hospita LOS [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    Hospital length of stay
  • ICU transfer [ Time Frame: 24 months (12 month before intervention and during intervention) ]
    % of admissions transferred to ICU after initial non-ICU admission
  • Duration of therapy [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Duration of therapy per treatment course
  • Guideline compliance [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Proportion of patients treated in compliance with facility-based guideline
  • De-escalation [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy between days 4 and 7
  • IV-oral switch [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Proportion of patients converted from iv to oral therapy between days 4 and 7
  • redunant anaerobic coverage [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    % of AD with redundant anaerobic coverage
  • Incidence of CDI [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Incidence of healthcare-facility onset healthcare facility associated Clostridium difficile infection denominated by PD and admission
  • Incidence of MDRO [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Incidence of clinical cultures with multidrug resistant organisms (MRSA, ESBL-E, CPE, VRE, multidrug resistant P. aeruginosa) denominated per PD and admissions*
  • Costs [ Time Frame: 24 months (12 month before intervention and during intervention) - Hospitalisation ]
    Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
  • User satisfaction [ Time Frame: Intervention period (12 months) ]
    User satisfaction with the system
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computerized Antibiotic Stewardship Study
Official Title  ICMJE Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)
Brief Summary Prescribing antibiotics frequently poses problems in practice, since patients don't always receive the right dosage of the right antibiotic for the right period of time. This promotes the emergence and spread of antibiotic resistance. The investigators of this trial aim to develop a system designed to help doctors to use antibiotics more appropriately. Under COMPASS (COMPuterized Antibiotic Stewardship Study), doctors in three Swiss hospitals will receive tips on the use of antibiotics that are integrated directly into electronic health record and will also be given regular feedback on their use of antibiotics. Parallel to this, data on the antimicrobial prescription practices of a control group which is not using the system will be collected.
Detailed Description

Inappropriate use of antimicrobials favours the spread and emergence of antimicrobial resistance and other adverse patient outcomes. Antimicrobial stewardship (AMS) programs aim to promote the appropriate use of antimicrobials. Most AMS interventions are based on manual, personalized peer review of antibiotic prescriptions by specialists and are therefore time and resource intensive. Informatics based, computerized approaches to AMS are a promising way to "automatize" AMS, but there have been only few randomized controlled trials analysing their effectiveness in the hospital setting.

The primary research question of this study is whether a multi-modal, computerized antibiotic stewardship intervention (I) reduces overall antibiotic exposure (O) in adult patients hospitalized in acute-care wards of secondary and tertiary care centers (P) compared to no such intervention ("standard-of- care") (C) over a one year time period (T) (the letters refer to the corresponding constituents of the PICOT framework).

The primary objective of the study is to use the methodological rigor of a parallel group, cluster-randomized, controlled superiority trial in three Swiss hospitals to answer the primary research question. Secondary objectives are to assess the impact of the intervention on quality of antibiotic use, patient, microbiologic and economic outcomes.

The primary outcome will be the difference in overall systemic antibiotic use measured in days of therapy (DOT) per admission based on administration data recorded in the electronic health record (EHR) over the whole intervention period. Secondary outcomes will include qualitative and quantitative antimicrobial use indicators (including non-HIV antivirals and antifungals), economic outcomes and key clinical and microbiologic indicators and patient safety indicators such as changes in readmission rates, need for intensive care and mortality.

The study hypothesis is that the multimodal intervention is superior to standard-of-care regarding the primary outcome, i.e. that the intervention leads to a statistically significant reduction in overall antibiotic use expressed as days of therapy per admission compared to no such intervention ("standard-of-care" antibiotic stewardship).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel group, cluster-randomized superiority trial
Masking: Single (Outcomes Assessor)
Masking Description:
Masking for care providers and investigators is unfortunately not feasible. Outcome assessors and data analysts will be blinded to the study arm allocation.
Primary Purpose: Treatment
Condition  ICMJE Communicable Diseases
Intervention  ICMJE
  • Other: Computerized decision support and audit & feedback
    • suggestion of guideline concordant antimicrobial treatment based on indication entry in the computerized physician order entry system
    • mandatory reevaluation of antimicrobial therapy therapy on calendar day 4 of treatment
    • suggestion of standard antimicrobial treatment duration according to indication
  • Other: Audit & Feedback
    * regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
  • Other: Standard antibiotic stewardship
    • Infectious diseases consultation "on demand"
    • Review of positive blood cultures
    • Availability of a antibiotic use guidelines (on paper and as PDF)
Study Arms  ICMJE
  • Experimental: Computerized decision support
    Interventions:
    • Other: Computerized decision support and audit & feedback
    • Other: Audit & Feedback
    • Other: Standard antibiotic stewardship
  • Active Comparator: Standard antibiotic stewardship
    Intervention: Other: Standard antibiotic stewardship
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2020)
16176
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
5000
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

CLUSTER (WARD) LEVEL

  • Acute-care wards with at least 150 admissions/year
  • Use of a computerized physician order entry system (CPOE)

PHYSICIAN LEVEL * All physicians involved in antibiotic prescribing decisions in the participating wards

PATIENT LEVEL

* All patients hospitalized in the participating wards

Exclusion Criteria:

CLUSTER (WARD) LEVEL

  • Emergency room
  • Outpatient clinics
  • Overflow wards
  • Absence of a matchable wards with regard to specialty and baseline antibiotic use
  • Hematopoietic stem cell

PHYSICIAN LEVEL * None

PATIENT LEVEL

* None

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120975
Other Study ID Numbers  ICMJE 2017-00454
407240_167079 ( Other Grant/Funding Number: Swiss National Science Foundation (SNSF) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Benedikt Huttner, University Hospital, Geneva
Study Sponsor  ICMJE Benedikt Huttner
Collaborators  ICMJE
  • Swiss National Science Foundation
  • University of Geneva, Switzerland
  • Ente Ospedaliero Cantonale, Ticino, Switzerland
Investigators  ICMJE
Principal Investigator: Benedikt D Huttner, MD, MS Geneva University Hospitals and University of Geneva
PRS Account University Hospital, Geneva
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP