Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388278
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia RF-net2018
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia Finalizzata di Rete 2018
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RF-net2018
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 qualityadequacy of antimicrobial use at the unit andor hospital level by hospital management B Control of the quantity of antimicrobials prescribeddispensedpurchased at unit level andor hospital level by hospital management C Monthlybimonthlyquarterlyhalf-yearly report of antibiotic consumption for each department with circulation of these reports at intra-hospital level
D Monthlybimonthlyquarterlysemiannual reporting of cases of C difficile infection carbapenem-resistant gram negative bacteria isolated from blood cultures and methicillin-resistant Saureus 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
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 qualityadequacy of antimicrobial use at the unit andor hospital level by hospital management B Control of the quantity of antimicrobials prescribeddispensedpurchased at unit level andor hospital level by hospital management C Monthlybimonthlyquarterlyhalf-yearly report of antibiotic consumption for each department with circulation of these reports at intra-hospital level
D Monthlybimonthlyquarterlysemiannual reporting of cases of C difficile infection carbapenem-resistant gram negative bacteria isolated from blood cultures and methicillin-resistant Saureus 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None