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Health-care Quality in Semi-intensive Care Units

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676347
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : December 30, 2021
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Study Description
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Brief Summary:
The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.

Condition or disease
Semi-intensive Care Unit Evaluation Quality

Detailed Description:
Collecting data of semi-intensive care units' patients and structural data of hospitals, healthcare quality's indicators will be realized. Starting from those indicators of insuccess, specific for different kinds of patients, it will be possibile to evaluate the general level of care in each singular semi-intensive care unit. The study will least for 5 years, but at the end of every year it will be realized a report of analysis to see the results of each unit.
Study Design
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Study Type : Observational
Estimated Enrollment : 39000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Improvement of the Health-care Quality in Semi-intensive Care Units
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025
Groups and Cohorts
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Group/Cohort
Eligible population
All patients admitted in the semi-intensive care units attending the study. Be basing on the average number of patients yearly treated in those units, we expect to have at least 39000 patients during the 5 years of the study.


Outcome Measures
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Primary Outcome Measures :
  1. Outcome for stationary patients with high risk of variability [ Time Frame: jan 2021 - dec 2025 ]
    hospitalization in semi-intensive care unit more than 2 days or transfer to intensive care unit

  2. Outcome for low gravity patients, with a low organ's damage [ Time Frame: jan 2021 - dec 2025 ]
    deterioration of the physiopathologic index

  3. Outcome for semi-intensive patients [ Time Frame: jan 2021 - dec 2025 ]
    transfer to intensive care unit or hospital mortality

  4. Outcome for high risk patients [ Time Frame: jan 2021 - dec 2025 ]
    transfer to intensive care unit or hospital mortality


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients hospitalised in a semi-intensive care unit attending the study, during a 5 years period of time (from 1st january 2021, to 31st december 2025)
Criteria

Inclusion Criteria:

  • all patients hospitalised in a semi-intensive care unit

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676347


Contacts
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Contact: Guido Bertolini 035 4535388 guido.bertolini@marionegri.it
Contact: Giulia Irene Ghilardi 035 4535388 giulia_irene.ghilardi@marionegri.it

Locations
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Italy
AOU Policlinico S. Marco Recruiting
Catania, Italy
Contact: Paola Noto, MD       p.noto@hotmail.it   
Ospedale Bufalini Recruiting
Cesena, Italy
Contact: Patrizia Cuppini, MD       patrizia.cuppini@auslromagna.it   
Ospedale Morgagni-Pierantoni Recruiting
Forlì, Italy
Contact: Fabbri Andrea, MD         
Ospedale Palmanova-Latisana Not yet recruiting
Latisana, Italy
Contact: Paola Perfetti, MD         
Istituto di Ricerche Farmacologiche Mario Negri IRCCS Active, not recruiting
Milan, Italy, 20156
Ospedale Santa Maria delle Grazie Recruiting
Napoli, Italy
Contact: Giovanni Porta, MD       dottorgiovanniporta@gmail.com   
Ospedale Guglielmo da Saliceto Not yet recruiting
Piacenza, Italy
Contact: Elio Antonucci, MD       E.Antonucci@ausl.pc.it   
AOU Pisana Not yet recruiting
Pisa, Italy
Contact: Gaetano Diricatti, MD       dirigaetano@gmail.com   
Ospedale Santa Maria delle Croci Recruiting
Ravenna, Italy
Contact: Lucia Pierpaoli, MD       luciapierpaoli@gmail.com   
AOU di Sassari Recruiting
Sassari, Italy
Contact: Paolo Pinna Parpaglia, MD       paolo.pinnaparpaglia@aousassari.it   
Ospedale Giovanni Bosco Recruiting
Torino, Italy
Contact: Marcella Converso, MD       lellaconverso@tiscali.it   
Ospedale Ca' Foncello Recruiting
Treviso, Italy
Contact: Angela Beltrame, MD       angela.beltrame@aulss2.veneto.it   
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
More Information
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT04676347    
Other Study ID Numbers: IRFMN_7998
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 30, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Protecting the privacy policy, all the data that underlie results in a publication will be shared. The scientific commettee of the study has to decide the criteria and the best way to share them

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No