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

March 15, 2022 updated by: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: 1 year

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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