Computerized Antibiotic Stewardship Study (COMPASS)
Primary Purpose
Communicable Diseases
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Computerized decision support and audit & feedback
Audit & Feedback
Standard antibiotic stewardship
Sponsored by
About this trial
This is an interventional treatment trial for Communicable Diseases focused on measuring Anti-Infective Agents, Decision Support Systems, Clinical, Quality Improvement
Eligibility 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
Sites / Locations
- Geneva University Hospitals
- Ente Ospedaliera Cantonale - Ospedale San Giovanni
- Ente Ospedaliera Cantonale - Ospedale Civico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computerized decision support
Standard antibiotic stewardship
Arm Description
Outcomes
Primary Outcome Measures
Days of therapy (DOT)/admission
Overall days of therapy of antibiotics per admission on the ward level
Secondary Outcome Measures
Days of therapy(DOT)/100 patient days
Overall days of therapy per 100 patient days (PD) on the ward level
Defined daily doses (DDD)/100 patient days (PD) and per admission
Overall defined daily doses per 100 patient days and admission on the ward level
Antimicrobial days (AD) per 100 PD and per admission
Length of therapy per 100 PD and per admission
Days per treatment period overall
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
All cause 30 day-mortality
In-hospital mortality
All-cause in-hospital mortality
Hospital readmission within 30 days of discharge
Unplanned hospital readmission within 30 days of discharge
Hospital length of stay (LOS)
Hospital length of stay
ICU transfer
% of admissions transferred to ICU after initial non-ICU admission
Guideline compliance
Proportion of patients treated in compliance with facility-based guideline
De-escalation
Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
IV-oral switch
Proportion of patients converted from intravenous to oral therapy between days 4 and 7
appropriate diagnostic exams
proportion of patients with appropriate diagnostic exams
Incidence of Clostridium difficile infections (CDI)
Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission
Incidence of multidrug-resistant organisms (MDRO)
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
User satisfaction with the system
Costs of administered antimicrobials
Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
costs of the intervention
total costs of the intervention
number of infectious diseases consultations
proportion of patients with infectious diseases consultation
Days per treatment period for community acquired pneumonia
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
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Full Information
NCT ID
NCT03120975
First Posted
April 14, 2017
Last Updated
November 17, 2020
Sponsor
Benedikt Huttner
Collaborators
Swiss National Science Foundation, University of Geneva, Switzerland, Ente Ospedaliero Cantonale, Ticino, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03120975
Brief Title
Computerized Antibiotic Stewardship Study
Acronym
COMPASS
Official Title
Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Benedikt Huttner
Collaborators
Swiss National Science Foundation, University of Geneva, Switzerland, Ente Ospedaliero Cantonale, Ticino, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communicable Diseases
Keywords
Anti-Infective Agents, Decision Support Systems, Clinical, Quality Improvement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, cluster-randomized superiority trial
Masking
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.
Allocation
Randomized
Enrollment
16176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized decision support
Arm Type
Experimental
Arm Title
Standard antibiotic stewardship
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Computerized decision support and audit & feedback
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Audit & Feedback
Intervention Description
* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
Intervention Type
Other
Intervention Name(s)
Standard antibiotic stewardship
Intervention Description
Infectious diseases consultation "on demand"
Review of positive blood cultures
Availability of a antibiotic use guidelines (on paper and as PDF)
Primary Outcome Measure Information:
Title
Days of therapy (DOT)/admission
Description
Overall days of therapy of antibiotics per admission on the ward level
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Days of therapy(DOT)/100 patient days
Description
Overall days of therapy per 100 patient days (PD) on the ward level
Time Frame
12 months
Title
Defined daily doses (DDD)/100 patient days (PD) and per admission
Description
Overall defined daily doses per 100 patient days and admission on the ward level
Time Frame
12 months
Title
Antimicrobial days (AD) per 100 PD and per admission
Description
Length of therapy per 100 PD and per admission
Time Frame
12 months
Title
Days per treatment period overall
Description
Overall days per treatment period. A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Time Frame
12 months
Title
30 day-mortality
Description
All cause 30 day-mortality
Time Frame
12 months
Title
In-hospital mortality
Description
All-cause in-hospital mortality
Time Frame
12 months
Title
Hospital readmission within 30 days of discharge
Description
Unplanned hospital readmission within 30 days of discharge
Time Frame
12 months
Title
Hospital length of stay (LOS)
Description
Hospital length of stay
Time Frame
12 months
Title
ICU transfer
Description
% of admissions transferred to ICU after initial non-ICU admission
Time Frame
12 months
Title
Guideline compliance
Description
Proportion of patients treated in compliance with facility-based guideline
Time Frame
12 months
Title
De-escalation
Description
Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
Time Frame
12 months
Title
IV-oral switch
Description
Proportion of patients converted from intravenous to oral therapy between days 4 and 7
Time Frame
12 months
Title
appropriate diagnostic exams
Description
proportion of patients with appropriate diagnostic exams
Time Frame
12 months
Title
Incidence of Clostridium difficile infections (CDI)
Description
Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission
Time Frame
12 months
Title
Incidence of multidrug-resistant organisms (MDRO)
Description
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
Time Frame
12 months
Title
User satisfaction
Description
User satisfaction with the system
Time Frame
12 months
Title
Costs of administered antimicrobials
Description
Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
Time Frame
12 months
Title
costs of the intervention
Description
total costs of the intervention
Time Frame
12 months
Title
number of infectious diseases consultations
Description
proportion of patients with infectious diseases consultation
Time Frame
12 months
Title
Days per treatment period for community acquired pneumonia
Description
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Time Frame
12 months
Title
Days per treatment period for upper urinary tract infection
Description
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedikt D Huttner, MD, MS
Organizational Affiliation
Geneva University Hospitals and University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Ente Ospedaliera Cantonale - Ospedale San Giovanni
City
Bellinzona
State/Province
TI
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Ente Ospedaliera Cantonale - Ospedale Civico
City
Lugano
State/Province
TI
ZIP/Postal Code
6903
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29950480
Citation
Catho G, De Kraker M, Waldispuhl Suter B, Valotti R, Harbarth S, Kaiser L, Elzi L, Meyer R, Bernasconi E, Huttner BD. Study protocol for a multicentre, cluster randomised, superiority trial evaluating the impact of computerised decision support, audit and feedback on antibiotic use: the COMPuterized Antibiotic Stewardship Study (COMPASS). BMJ Open. 2018 Jun 27;8(6):e022666. doi: 10.1136/bmjopen-2018-022666.
Results Reference
background
PubMed Identifier
32736330
Citation
Catho G, Centemero NS, Catho H, Ranzani A, Balmelli C, Landelle C, Zanichelli V, Huttner BD; on the behalf of the Q-COMPASS study group. Factors determining the adherence to antimicrobial guidelines and the adoption of computerised decision support systems by physicians: A qualitative study in three European hospitals. Int J Med Inform. 2020 Sep;141:104233. doi: 10.1016/j.ijmedinf.2020.104233. Epub 2020 Jul 13.
Results Reference
result
PubMed Identifier
35870478
Citation
Catho G, Sauser J, Coray V, Da Silva S, Elzi L, Harbarth S, Kaiser L, Marti C, Meyer R, Pagnamenta F, Portela J, Prendki V, Ranzani A, Centemero NS, Stirnemann J, Valotti R, Vernaz N, Suter BW, Bernasconi E, Huttner BD; COMPASS study group. Impact of interactive computerised decision support for hospital antibiotic use (COMPASS): an open-label, cluster-randomised trial in three Swiss hospitals. Lancet Infect Dis. 2022 Oct;22(10):1493-1502. doi: 10.1016/S1473-3099(22)00308-5. Epub 2022 Jul 20.
Results Reference
derived
Links:
URL
http://www.nfp72.ch/en/projects/module-3-optimised-use-of-antibiotics/using-computers-to-improve-prescription-practices
Description
Lay summary of the project
Learn more about this trial
Computerized Antibiotic Stewardship Study
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