Safety Issues and SurvIval For Medical Outliers (SISIFO)

Safety Issues and SurvIval For Medical Outliers (SISIFO) - Not-for-profit Observational Study to Evaluate the Quality and Safety of Care in Patients "Outliers" Hospitalized With Medical Diseases

Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control".

Study Overview

• Status: Terminated
• Conditions: Hospitalization
• Intervention / Treatment: Other: Clinical data collection

Detailed Description

Phase 1 - Patients enrollment (October 2018 - May 2019) Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" (max 10 per month) and 30 patients "control" (max 6 per month). It will be collected clinical and organisational information. The Investigators of the wards that will not have patients "outliers" will have to enroll 70 patients "control" (max 15 per month).

Phase 2 - Database review and validation (June 2019 - October 2019) The data collected will be analysed to process the endpoints.

• Study Type: Observational
• Enrollment (Actual): 2056

Contacts and Locations

Study Locations

• Italy
  • Bisceglie, Italy
    • Ospedale di Bisceglie - Trani
  • Cagliari, Italy
    • Azienda Ospedaliera Brotzu
  • Cagliari, Italy
    • Ospedale Santissima Trinità
  • Cattolica, Italy
    • Ospedale Cervesi
  • Conegliano, Italy
    • Ospedale di Conegliano
  • Cremona, Italy
    • Istituti Ospitalieri di Cremona
  • Forlì, Italy
    • Ospedale Morgagni Pierantoni
  • Genova, Italy
    • Ospedale Villa Scassi
  • Genova, Italy
    • Ospedale Evangelico
  • Genova, Italy
    • Ospedale Policlinico S. Martino
  • La Spezia, Italy
    • Ospedale Sant'Andrea
  • Latina, Italy
    • Ospedale S. Maria Goretti
  • Lavagna, Italy
    • Ospedale di Lavagna
  • Legnano, Italy
    • Ospedale di Legnano
  • Magenta, Italy
    • Ospedale di Magenta
  • Milano, Italy
    • Ospedale San Carlo Borromeo
  • Napoli, Italy
    • Ospedale Buon Consiglio Fatebenefratelli
  • Pontedera, Italy
    • Ospedale Felice Lotti
  • Prato, Italy
    • Nuovo Ospedale S. Stefano
  • Rimini, Italy
    • Ospedale Infermi
  • Roma, Italy
    • Ospedale San Giovanni Calibita Fatebenefratelli
  • San Daniele Del Friuli, Italy
    • Ospedale San'Antonio
  • San Gavino Monreale, Italy
    • Ospedale Nostra Signora di Bonaria
  • San Remo, Italy
    • Ospedale G. Borea
  • Sarzana, Italy
    • Ospedale San Bartolomeo
  • Sassari, Italy
    • Ospedale Civile SS Annunziata
  • Sestri Levante, Italy
    • Ospedale di Sestri Levante
  • Terni, Italy
    • Azienda Ospedaliera S. Maria
  • Torino, Italy
    • Ospedale Cottolengo
  • Treviglio, Italy
    • Ospedale di Treviglio
  • Vercelli, Italy
    • Ospedale Sant'Andrea
  • Voghera, Italy
    • Ospedale Civile di Voghera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for any cause.

Description

Inclusion Criteria:

Outlier:

• Age ≥ 18 years
• Signature of informed consent
• Patients coming from Emergency Room
• Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
• Patients spending at least one night in another ward for lack of available beds
• Consecutive cases

Control:

• Age ≥ 18 years
• Signature of informed consent
• Patients coming from Emergency Room
• Patients to be hospitalized in Internal Medicine or similar (not day-hospital)
• Patients hospitalized ab initio in Internal Medicine or similar for at least one night
• Consecutive cases

Exclusion Criteria (Outlier and Control):

• Age < 18 years
• Patients hospitalized in Internal Medicine or similar coming from other wards or directly from home

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Patients hospitalized ab initio in Internal Medicine or similar for at least one night	Other: Clinical data collection; There will not be any experimental intervention. The study will be conducted according with normal clinical practice.
Outlier; Patients spending at least one night in a ward different from Internal Medicine despite the presence of medical diseases, due to lack of available beds	Other: Clinical data collection; There will not be any experimental intervention. The study will be conducted according with normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhospital mortality	Evaluation of the inhospital mortality in patients "outliers" compared to patients that are hospitalized ab initio in the relevant ward (Internal Medicine - patients "control")	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Evaluation of the adverse events in patients "outliers" compared to patients that are hospitalized ab initio in the relevant ward (Internal Medicine - patients "control")	8 months
Mortality rate	Mortality rate after 30 days and after 3 months from the hospitalization	3 months

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Collaborators: University of Genova
• Investigators: Study Director: Mauro Campanini, FADOI Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Actual): April 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Outliers
• Other Study ID Numbers: FADOI.08.2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No