Computerized Antibiotic Stewardship Study (COMPASS)
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|ClinicalTrials.gov Identifier: NCT03120975|
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Communicable Diseases||Other: Computerized decision support and audit & feedback Other: Audit & Feedback Other: Standard antibiotic stewardship||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel group, cluster-randomized superiority trial|
|Masking:||Single (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.|
|Official Title:||Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)|
|Actual Study Start Date :||September 3, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
|Experimental: Computerized decision support||
Other: Computerized decision support and audit & feedback
Other: Audit & Feedback
* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
Other: Standard antibiotic stewardship
|Active Comparator: Standard antibiotic stewardship||
Other: Standard antibiotic stewardship
- Days of therapy (DOT)/admission [ Time Frame: 12 months ]Overall days of therapy of antibiotics per admission on the ward level
- Days of therapy(DOT)/100 patient days [ Time Frame: 12 months ]Overall days of therapy per 100 patient days (PD) on the ward level
- 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
- Antimicrobial days (AD) per 100 PD and per admission [ Time Frame: 12 months ]Length of therapy per 100 PD and per admission
- 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.
- 30 day-mortality [ Time Frame: 12 months ]All cause 30 day-mortality
- In-hospital mortality [ Time Frame: 12 months ]All-cause in-hospital mortality
- Hospital readmission within 30 days of discharge [ Time Frame: 12 months ]Unplanned hospital readmission within 30 days of discharge
- Hospital length of stay (LOS) [ Time Frame: 12 months ]Hospital length of stay
- ICU transfer [ Time Frame: 12 months ]% of admissions transferred to ICU after initial non-ICU admission
- Guideline compliance [ Time Frame: 12 months ]Proportion of patients treated in compliance with facility-based guideline
- De-escalation [ Time Frame: 12 months ]Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
- IV-oral switch [ Time Frame: 12 months ]Proportion of patients converted from intravenous to oral therapy between days 4 and 7
- appropriate diagnostic exams [ Time Frame: 12 months ]proportion of patients with appropriate diagnostic exams
- 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
- 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
- User satisfaction [ Time Frame: 12 months ]User satisfaction with the system
- Costs of administered antimicrobials [ Time Frame: 12 months ]Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
- costs of the intervention [ Time Frame: 12 months ]total costs of the intervention
- number of infectious diseases consultations [ Time Frame: 12 months ]proportion of patients with infectious diseases consultation
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120975
|Contact: Benedikt D Huttner, MD, MS||+41223729242||Benedikt.Huttner@hcuge.ch|
|Contact: Enos Bernasconi, MDemail@example.com|
|Geneva University Hospitals||Not yet recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: Benedikt D Huttner, MD, MS +41223729242 firstname.lastname@example.org|
|Contact: Stephan J Harbarth, MD, MS +41223723357 email@example.com|
|Principal Investigator: Benedikt D Huttner, MD, MS|
|Sub-Investigator: Stephan Harbarth, MD, MS|
|Sub-Investigator: Laurent Kaiser, MD|
|Sub-Investigator: Rodolphe Meyer, MD|
|Ente Ospedaliera Cantonale - Ospedale San Giovanni||Recruiting|
|Bellinzona, TI, Switzerland, 6500|
|Contact: Luigia Elzi, MD +41918118529 firstname.lastname@example.org|
|Principal Investigator: Luigia Elzi, MD|
|Ente Ospedaliera Cantonale - Ospedale Civico||Recruiting|
|Lugano, TI, Switzerland, 6903|
|Contact: Enos Bernasconi, MD +419181160 22 email@example.com|
|Principal Investigator: Enos Bernasconi, MD|
|Principal Investigator:||Benedikt D Huttner, MD, MS||Geneva University Hospitals and University of Geneva|