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Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018)

Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia: Finalizzata di Rete 2018

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06388278
Acronym
RF-net2018
Enrollment
50000
Registered
2024-04-29
Start date
2023-03-01
Completion date
2025-04-15
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Stewardship, Cost-effectiveness Analysis

Keywords

antimicrobial stewardship, cost-effectiveness analysis

Brief summary

Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: RF-net2018 is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms).

Detailed description

Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: Finalizzata di Rete 2018 is a prospective, experimental, multicenter, pre-post study. The objectives of this study are: * Objective 1: evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection. These patients will be identified in a network of 18 hospital facilities participating in our study * Objective 2: evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. These patients will be identified in a network of 18 hospital facilities participating in our study * Objective 3: compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project Study population for different objectives are: * For Objective 1 and 3: All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy (ongoing consensus activity) * For Objective 2: Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified The study will include two main phases of analysis: * The pre-intervention-phase (6 months) * The intervention-phase (6 months) The pre-intervention phase will serve as a control for the intervention phase and the unit of measurement used is month-department Intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include: ⦁ HOSPITAL COMMITMENT : A. Definition of an official group of specialists responsible for antimicrobial stewardship activities (infectious diseases specialist, IPC referent, pharmacist e microbiologist). B. Presence of a multidisciplinary reference team that includes representatives from other medical specialties (in addition to the figures reported in point A.) ⦁ TRACKING AND REPORTING A. Monitoring the quality/adequacy of antimicrobial use at the unit and/or hospital level by hospital management B. Control of the quantity of antimicrobials prescribed/dispensed/purchased at unit level and/or hospital level by hospital management C. Monthly/bimonthly/quarterly/half-yearly report of antibiotic consumption for each department with circulation of these reports at intra-hospital level. D. Monthly/bimonthly/quarterly/semiannual reporting of cases of C. difficile infection, carbapenem-resistant gram negative bacteria isolated from blood cultures and methicillin-resistant S.aureus (MRSA) with subsequent circulation of these reports at intra-hospital level. * ACTION A. Infectious disease review of carbapenem prescription (in any form) B. Ward rounds focusing on infection management or antibiotic prescribing in departments in your hospital * EDUCATION A. Training events aimed at medical and nursing healthcare personnel with a focus on the use of antibiotics belonging to the carbapenem family and on controlling the spread of multidrug-resistant (MDR) microorganisms

Interventions

None listed

Sponsors

Regione Lombardia
CollaboratorOTHER
Ministero della Salute, Italy
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy * Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified

Exclusion criteria

* patients non included in Inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection12 monthsevaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection. These patients will be identified in a network of 18 hospital facilities participating in our study
evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria.12 monthsevaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. These patients will be identified in a network of 18 hospital facilities participating in our study
compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project12 monthscompare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. These patients will be identified in a network of 18 hospital facilities participating in our study

Countries

Italy

Contacts

Primary ContactGIULIA RENISI
clinicaltrial.malinf@policlinico.mi.it+393887429609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026