Clinical trial NCT03120975: Computerized Antibiotic Stewardship Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Communicable Diseases
Keywords: Anti-Infective Agents
Decision Support Systems, Clinical
Quality Improvement
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University of Geneva, Switzerland
name: Ente Ospedaliero Cantonale, Ticino, Switzerland
First posted: 2017-04-19
Enrollment: 16176
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, cluster-randomized superiority trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Days of therapy (DOT)/admission
timeFrame: 12 months
Secondary outcomes:
measure: Days of therapy(DOT)/100 patient days
timeFrame: 12 months
measure: Defined daily doses (DDD)/100 patient days (PD) and per admission
timeFrame: 12 months
measure: Antimicrobial days (AD) per 100 PD and per admission
timeFrame: 12 months
measure: Days per treatment period overall
timeFrame: 12 months
measure: 30 day-mortality
timeFrame: 12 months
measure: In-hospital mortality
timeFrame: 12 months
measure: Hospital readmission within 30 days of discharge
timeFrame: 12 months
measure: Hospital length of stay (LOS)
timeFrame: 12 months
measure: ICU transfer
timeFrame: 12 months
measure: Guideline compliance
timeFrame: 12 months
measure: De-escalation
timeFrame: 12 months
measure: IV-oral switch
timeFrame: 12 months
measure: appropriate diagnostic exams
timeFrame: 12 months
measure: Incidence of Clostridium difficile infections (CDI)
timeFrame: 12 months
measure: Incidence of multidrug-resistant organisms (MDRO)
timeFrame: 12 months
measure: User satisfaction
timeFrame: 12 months
measure: Costs of administered antimicrobials
timeFrame: 12 months
measure: costs of the intervention
timeFrame: 12 months
measure: number of infectious diseases consultations
timeFrame: 12 months
measure: Days per treatment period for community acquired pneumonia
timeFrame: 12 months
measure: Days per treatment period for upper urinary tract infection
timeFrame: 12 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
state: GE
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliera Cantonale - Ospedale San Giovanni
state: TI
city: Lugano
country: Switzerland
facility: Ente Ospedaliera Cantonale - Ospedale Civico
state: TI
Study officials:
affiliation: Geneva University Hospitals and University of Geneva
name: Benedikt D Huttner, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.