Computerized Antibiotic Stewardship Study (COMPASS)

November 17, 2020 updated by: Benedikt Huttner

Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • GE
      • Geneva, GE, Switzerland, 1211
        • Geneva University Hospitals
    • TI
      • Bellinzona, TI, Switzerland, 6500
        • Ente Ospedaliera Cantonale - Ospedale San Giovanni
      • Lugano, TI, Switzerland, 6903
        • Ente Ospedaliera Cantonale - Ospedale Civico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days of therapy (DOT)/admission
Time Frame: 12 months
Overall days of therapy of antibiotics per admission on the ward level
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 12 months
All-cause in-hospital mortality
12 months
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
12 months
Days of therapy(DOT)/100 patient days
Time Frame: 12 months
Overall days of therapy per 100 patient days (PD) on the ward level
12 months
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
12 months
Antimicrobial days (AD) per 100 PD and per admission
Time Frame: 12 months
Length of therapy per 100 PD and per admission
12 months
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.
12 months
30 day-mortality
Time Frame: 12 months
All cause 30 day-mortality
12 months
Hospital readmission within 30 days of discharge
Time Frame: 12 months
Unplanned hospital readmission within 30 days of discharge
12 months
Hospital length of stay (LOS)
Time Frame: 12 months
Hospital length of stay
12 months
ICU transfer
Time Frame: 12 months
% of admissions transferred to ICU after initial non-ICU admission
12 months
Guideline compliance
Time Frame: 12 months
Proportion of patients treated in compliance with facility-based guideline
12 months
De-escalation
Time Frame: 12 months
Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
12 months
IV-oral switch
Time Frame: 12 months
Proportion of patients converted from intravenous to oral therapy between days 4 and 7
12 months
appropriate diagnostic exams
Time Frame: 12 months
proportion of patients with appropriate diagnostic exams
12 months
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
12 months
User satisfaction
Time Frame: 12 months
User satisfaction with the system
12 months
Costs of administered antimicrobials
Time Frame: 12 months
Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
12 months
costs of the intervention
Time Frame: 12 months
total costs of the intervention
12 months
number of infectious diseases consultations
Time Frame: 12 months
proportion of patients with infectious diseases consultation
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benedikt Huttner

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Science Foundation
University of Geneva, Switzerland
Ente Ospedaliero Cantonale, Ticino, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benedikt D Huttner, MD, MS, Geneva University Hospitals and University of Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-00454
  • 407240_167079 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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