NCT04676347

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

December 15, 2020

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Outcome for stationary patients with high risk of variability

    hospitalization in semi-intensive care unit more than 2 days or transfer to intensive care unit

    jan 2021 - dec 2025

  • Outcome for low gravity patients, with a low organ's damage

    deterioration of the physiopathologic index

    jan 2021 - dec 2025

  • Outcome for semi-intensive patients

    transfer to intensive care unit or hospital mortality

    jan 2021 - dec 2025

  • Outcome for high risk patients

    transfer to intensive care unit or hospital mortality

    jan 2021 - dec 2025

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • all patients hospitalised in a semi-intensive care unit

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Milan, Milan, 20156, Italy

ACTIVE NOT RECRUITING

ASO SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

RECRUITING

Ospedale Umberto Parini

Aosta, 11100, Italy

ACTIVE NOT RECRUITING

Ospedale San Bassiano

Bassano del Grappa, Italy

NOT YET RECRUITING

Ospedale Maggiore

Bologna, Italy

RECRUITING

AOU Policlinico S. Marco

Catania, Italy

RECRUITING

AOU Policlinico San Marco

Catania, Italy

RECRUITING

Ospedale Bufalini

Cesena, Italy

RECRUITING

Ospedale Santa Maria Annunziata

Florence, 50012, Italy

ACTIVE NOT RECRUITING

Ospedale Morgagni-Pierantoni

Forlì, Italy

ACTIVE NOT RECRUITING

Ospedale Palmanova-Latisana

Latisana, Italy

ACTIVE NOT RECRUITING

Ospedali Riuniti

Livorno, Italy

NOT YET RECRUITING

ASST Lodi

Lodi, Italy

NOT YET RECRUITING

Ospedale Santa Maria delle Grazie

Napoli, Italy

RECRUITING

AOU San Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Ospedale Guglielmo da Saliceto

Piacenza, Italy

NOT YET RECRUITING

Ospedale E.Agnelli

Pinerolo, 10064, Italy

RECRUITING

AOU Pisana

Pisa, Italy

ACTIVE NOT RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, Italy

RECRUITING

Ospedale Sant'Eugenio

Roma, 00144, Italy

RECRUITING

AOU di Sassari

Sassari, Italy

RECRUITING

Ospedale Giovanni Bosco

Torino, Italy

RECRUITING

Ospedale Ca' Foncello

Treviso, Italy

ACTIVE NOT RECRUITING

Santa Maria della Misericordia

Udine, 33100, Italy

RECRUITING

Ospedale Michele e Pietro Ferrero

Verduno, Italy

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 21, 2020

Study Start

July 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations