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

NCT03702504 | Unknown

• 1 other identifier: N° 2007331
• Study Type: observational
• Target: 250,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Medicine

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted in partecipating ICU

You may qualify if:

• All the patients admitted in ICU

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

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

Lecco, Lombardy, 23900, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: October 11, 2018
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2025
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

IT (1)