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

NCT ID: NCT03702504

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Intensive Care Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All the patients admitted in ICU

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

Friedrich Schiller University of Jena

UNKNOWN

Sponsor Role collaborator

General Hospital of Novo mesto

OTHER

Sponsor Role collaborator

Intensive Care Forum (ICF)

UNKNOWN

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role collaborator

University of Nicosia

OTHER

Sponsor Role collaborator

Semmelweis University Budapest

UNKNOWN

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

Univerzitetni Klinikni Center Ljubljana

UNKNOWN

Sponsor Role collaborator

Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

University of Crete Medical School - University Hospital of Heraklion

UNKNOWN

Sponsor Role collaborator

Orobix Srl

UNKNOWN

Sponsor Role collaborator

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1

Lecco, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giuseppe Nattino, MD

Role: primary

0354535313

Role: backup

0354535313

Other Identifiers

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N° 2007331

Identifier Type: -

Identifier Source: org_study_id

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