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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03702504
Enrollment
250000
Registered
2018-10-11
Start date
2008-11-30
Completion date
2025-12-31
Last updated
2022-03-16

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

Conditions

Intensive Care Medicine

Brief summary

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* All the patients admitted in ICU

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Hospital mortality1 yearHospital 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.

Countries

Italy

Outcome results

None listed

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