Clinical trial NCT03702504: Margherita-PROSAFE:Promoting Patient Safety and Quality Improvement in Critical Care
Official title: Margherita-PROSAFE:Promoting Patient Safety and Quality Improvement in Critical Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Medicine
Lead sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Sponsor class: OTHER
Collaborators: name: European Commission
name: Friedrich Schiller University of Jena
name: General Hospital of Novo mesto
name: Intensive Care Forum (ICF)
name: Medical University of Warsaw
name: University of Nicosia
name: Semmelweis University Budapest
name: University College, London
name: Univerzitetni Klinikni Center Ljubljana
name: Ben-Gurion University of the Negev
name: University of Crete Medical School - University Hospital of Heraklion
name: Orobix Srl
First posted: 2018-10-11
Enrollment: 250000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in partecipating ICU

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.

Eligibility criteria: Inclusion Criteria:

* All the patients admitted in ICU

Exclusion Criteria:

* None

Primary outcomes:
measure: Hospital mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
state: Lombardia
Study officials:
References: