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Computerized Antibiotic Stewardship Study (COMPASS)

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ClinicalTrials.gov Identifier: NCT03120975
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : February 5, 2019
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

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.

Condition or disease Intervention/treatment Phase
Communicable Diseases Other: Computerized decision support and audit & feedback Other: Audit & Feedback Other: Standard antibiotic stewardship Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
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
Official Title: Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Computerized decision support 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)

Active Comparator: Standard antibiotic stewardship 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)




Primary Outcome Measures :
  1. Days of therapy (DOT)/admission [ Time Frame: 12 months ]
    Overall days of therapy of antibiotics per admission on the ward level


Secondary Outcome Measures :
  1. Days of therapy(DOT)/100 patient days [ Time Frame: 12 months ]
    Overall days of therapy per 100 patient days (PD) on the ward level

  2. 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

  3. Antimicrobial days (AD) per 100 PD and per admission [ Time Frame: 12 months ]
    Length of therapy per 100 PD and per admission

  4. 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.

  5. 30 day-mortality [ Time Frame: 12 months ]
    All cause 30 day-mortality

  6. In-hospital mortality [ Time Frame: 12 months ]
    All-cause in-hospital mortality

  7. Hospital readmission within 30 days of discharge [ Time Frame: 12 months ]
    Unplanned hospital readmission within 30 days of discharge

  8. Hospital length of stay (LOS) [ Time Frame: 12 months ]
    Hospital length of stay

  9. ICU transfer [ Time Frame: 12 months ]
    % of admissions transferred to ICU after initial non-ICU admission

  10. Guideline compliance [ Time Frame: 12 months ]
    Proportion of patients treated in compliance with facility-based guideline

  11. De-escalation [ Time Frame: 12 months ]
    Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment

  12. IV-oral switch [ Time Frame: 12 months ]
    Proportion of patients converted from intravenous to oral therapy between days 4 and 7

  13. appropriate diagnostic exams [ Time Frame: 12 months ]
    proportion of patients with appropriate diagnostic exams

  14. 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

  15. 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

  16. User satisfaction [ Time Frame: 12 months ]
    User satisfaction with the system

  17. Costs of administered antimicrobials [ Time Frame: 12 months ]
    Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics

  18. costs of the intervention [ Time Frame: 12 months ]
    total costs of the intervention

  19. number of infectious diseases consultations [ Time Frame: 12 months ]
    proportion of patients with infectious diseases consultation

  20. 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.

  21. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120975


Contacts
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Contact: Benedikt D Huttner, MD, MS +41223729242 Benedikt.Huttner@hcuge.ch
Contact: Enos Bernasconi, MD +41918116022 enos.bernasconi@eoc.ch

Locations
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Switzerland
Geneva University Hospitals Not yet recruiting
Geneva, GE, Switzerland, 1211
Contact: Benedikt D Huttner, MD, MS    +41223729242    benedikt.huttner@hcuge.ch   
Contact: Stephan J Harbarth, MD, MS    +41223723357    stephan.harbarth@hcuge.ch   
Principal Investigator: Benedikt D Huttner, MD, MS         
Sub-Investigator: Stephan Harbarth, MD, MS         
Sub-Investigator: Laurent Kaiser, MD         
Sub-Investigator: Rodolphe Meyer, MD         
Ente Ospedaliera Cantonale - Ospedale San Giovanni Recruiting
Bellinzona, TI, Switzerland, 6500
Contact: Luigia Elzi, MD    +41918118529    luigia.elzi@eoc.ch   
Principal Investigator: Luigia Elzi, MD         
Ente Ospedaliera Cantonale - Ospedale Civico Recruiting
Lugano, TI, Switzerland, 6903
Contact: Enos Bernasconi, MD    +419181160 22    enos.bernasconi@eoc.ch   
Principal Investigator: Enos Bernasconi, MD         
Sponsors and Collaborators
Benedikt Huttner
Swiss National Science Foundation
University of Geneva, Switzerland
Ente Ospedaliero Cantonale, Ticino, Switzerland
Investigators
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Principal Investigator: Benedikt D Huttner, MD, MS Geneva University Hospitals and University of Geneva

Additional Information:
Publications:
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Responsible Party: Benedikt Huttner, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03120975     History of Changes
Other Study ID Numbers: 2017-00454
407240_167079 ( Other Grant/Funding Number: Swiss National Science Foundation (SNSF) )
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benedikt Huttner, University Hospital, Geneva:
Anti-Infective Agents
Decision Support Systems, Clinical
Quality Improvement
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents