Margherita-PROSAFE:Promoting Patient Safety and Quality Improvement in Critical Care

The general objective is to promote patient safety and quality improvement in critical care towards a significant reduction of observed mortality rates and economic costs through the improvement of outcomes and reduction of medical errors.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Medicine

Detailed Description

Intensive care is one of the largest, most expensive, most complex components of European healthcare; each year about one million patients are admitted to intensive care units across Europe. The project contributes to European society in the long-term by promoting cooperation between member states in the critical care domain, with a view to improving the safety of patients admitted to ICUs and to continuously assessing performance through international comparison of outcomes and procedures. It also contributes to the exchange of good practice, reduce medical errors and promote high quality services in public health.

Patient safety and quality of care measurement and improvement are among the most important, challenging aspects of public health. The intensive and critical care domains need continuous monitoring and improvement considering the high mortality rates in and major financial investments required by ICUs. However, collection of ICU performance data is not standardized and no transnational EU project to improve patient safety and to assess performance and quality of care is currently operating for ICUs.

The project provides long-term benefits to European society by promoting cooperation between member states in the critical care domain with a view to improving the safety of patients admitted to ICUs and performing continuous performance evaluation through comparison of outcomes and procedures at international level.

The aim of this project is to export the positive results achieved through an Italian experience (Margherita system) to other European countries, addressing in particular new member states where benchmarking is sparse and uncoordinated and quality assessment and comparison is needed.

Methods and means:

It is proposed to build an ICU network across EU to collect standardized data on admitted patients, to perform statistical analyses based on national and intercountry comparisons and to appropriately identify and manage strengths and weaknesses in performance.

• Study Type: Observational
• Enrollment (Anticipated): 250000

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Lecco, Lombardia, Italy, 23900
      • Recruiting
      • Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
      • Contact: Giuseppe Nattino, MD; Phone Number: 0354535313
      • Contact: Phone Number: 0354535313
      • Principal Investigator: Giuseppe Nattino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted in partecipating ICU

Description

Inclusion Criteria:

• All the patients admitted in ICU

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital mortality	Hospital mortality is required to calculated different indicators: SMR: it is the ratio between the mortality rate actually observed in a specific centre and the mortality that would have been expected had this centre performed according to the average of all the other participating centers, as they behaved in the same period, in the same country.; VLAD: it shows the performance of each individual ICU (expressed along the y axis) against time (reported on the x axis). When the plot rises, it means that in the period in question the ICU performed better than the average, in terms of lives saved, and vice versa when the plot declines, in terms of lives lost compared to the average performance.; GiViTI Calibration belt: it represents the confidence band that correlates the observed and the expected (according to the average performance) mortality.	1 year

Collaborators and Investigators

• Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Collaborators: University College, London; Medical University of Warsaw; European Commission; Ben-Gurion University of the Negev; University of Nicosia; Friedrich Schiller University of Jena; General Hospital Novo Mesto; Intensive Care Forum (ICF); Semmelweis University Budapest; Univerzitetni Klinikni Center Ljubljana; University of Crete Medical School - University Hospital of Heraklion; Orobix Srl

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: N° 2007331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No