Computerized Antibiotic Stewardship Study

Communicable Diseases Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120975
• Other study ID #: 2017-00454
• Secondary ID: 407240_167079
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16176
• Est. completion date: March 31, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

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
• Audit & Feedback
* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
• Standard antibiotic stewardship
Infectious diseases consultation "on demand" Review of positive blood cultures Availability of a antibiotic use guidelines (on paper and as PDF)

Locations

Country	Name	City	State
Switzerland	Ente Ospedaliera Cantonale - Ospedale San Giovanni	Bellinzona	TI
Switzerland	Geneva University Hospitals	Geneva	GE
Switzerland	Ente Ospedaliera Cantonale - Ospedale Civico	Lugano	TI

Sponsors (4)

Lead Sponsor	Collaborator
Benedikt Huttner	Ente Ospedaliero Cantonale, Ticino, Switzerland, Swiss National Science Foundation, University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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 system — View Citation

Catho G, De Kraker M, Waldispühl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of therapy (DOT)/admission	Overall days of therapy of antibiotics per admission on the ward level	12 months
Secondary	Days of therapy(DOT)/100 patient days	Overall days of therapy per 100 patient days (PD) on the ward level	12 months
Secondary	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	12 months
Secondary	Antimicrobial days (AD) per 100 PD and per admission	Length of therapy per 100 PD and per admission	12 months
Secondary	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.	12 months
Secondary	30 day-mortality	All cause 30 day-mortality	12 months
Secondary	In-hospital mortality	All-cause in-hospital mortality	12 months
Secondary	Hospital readmission within 30 days of discharge	Unplanned hospital readmission within 30 days of discharge	12 months
Secondary	Hospital length of stay (LOS)	Hospital length of stay	12 months
Secondary	ICU transfer	% of admissions transferred to ICU after initial non-ICU admission	12 months
Secondary	Guideline compliance	Proportion of patients treated in compliance with facility-based guideline	12 months
Secondary	De-escalation	Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment	12 months
Secondary	IV-oral switch	Proportion of patients converted from intravenous to oral therapy between days 4 and 7	12 months
Secondary	appropriate diagnostic exams	proportion of patients with appropriate diagnostic exams	12 months
Secondary	Incidence of Clostridium difficile infections (CDI)	Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission	12 months
Secondary	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	12 months
Secondary	User satisfaction	User satisfaction with the system	12 months
Secondary	Costs of administered antimicrobials	Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics	12 months
Secondary	costs of the intervention	total costs of the intervention	12 months
Secondary	number of infectious diseases consultations	proportion of patients with infectious diseases consultation	12 months
Secondary	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.	12 months
Secondary	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.	12 months

External Links

•   Lay summary of the project