NCT03120975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

April 14, 2017

Last Update Submit

November 17, 2020

Conditions

Communicable Diseases

Keywords

Anti-Infective AgentsDecision Support Systems, ClinicalQuality Improvement

Outcome Measures

Primary Outcomes (1)

  • Days of therapy (DOT)/admission

    Overall days of therapy of antibiotics per admission on the ward level

    12 months

Secondary Outcomes (21)

  • Days of therapy(DOT)/100 patient days

    12 months

  • Defined daily doses (DDD)/100 patient days (PD) and per admission

    12 months

  • Antimicrobial days (AD) per 100 PD and per admission

    12 months

  • Days per treatment period overall

    12 months

  • 30 day-mortality

    12 months

  • +16 more secondary outcomes

Study Arms (2)

Computerized decision support

EXPERIMENTAL
Other: Computerized decision support and audit & feedbackOther: Audit & FeedbackOther: Standard antibiotic stewardship

Standard antibiotic stewardship

ACTIVE COMPARATOR
Other: Standard antibiotic stewardship

Interventions

Computerized decision support and audit & feedbackOTHER

* 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

Computerized decision support
Audit & FeedbackOTHER

\* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)

Computerized decision support
Standard antibiotic stewardshipOTHER

* Infectious diseases consultation "on demand" * Review of positive blood cultures * Availability of a antibiotic use guidelines (on paper and as PDF)

Computerized decision supportStandard antibiotic stewardship

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location

Ente Ospedaliera Cantonale - Ospedale San Giovanni

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Ente Ospedaliera Cantonale - Ospedale Civico

Lugano, Canton Ticino, 6903, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 29950480BACKGROUND

  • 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.

    PMID: 32736330RESULT

  • 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.

    PMID: 35870478DERIVED

Related Links

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benedikt D Huttner, MD, MS

    Geneva University Hospitals and University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking for care providers and investigators is unfortunately not feasible. Outcome assessors and data analysts will be blinded to the study arm allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group, cluster-randomized superiority trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 19, 2017

Study Start

September 3, 2018

Primary Completion

February 29, 2020

Study Completion

March 31, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(3)