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

April 24, 2024 updated by: malattie_infettive, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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).

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection
Time Frame: 12 months
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
12 months
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.
Time Frame: 12 months
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
12 months
compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project
Time Frame: 12 months
compare 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

Ministero della Salute, Italy
Regione Lombardia

Investigators

  • Principal Investigator: Andrea Gori, IRCCS Fondazione Cà Granda Policlinico of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NET-2018-12366982-4/ASP_LOMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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