Clinical trial NCT03651414: Safety Issues and SurvIval For Medical Outliers
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hospitalization
Keywords: Outliers
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
Collaborators: name: University of Genova
First posted: 2018-08-29
Enrollment: 2056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for any cause.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inhospital mortality
timeFrame: 8 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 8 months
measure: Mortality rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Bisceglie
country: Italy
facility: Ospedale di Bisceglie - Trani
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu
city: Cagliari
country: Italy
facility: Ospedale Santissima Trinità
city: Cattolica
country: Italy
facility: Ospedale Cervesi
city: Conegliano
country: Italy
facility: Ospedale di Conegliano
city: Cremona
country: Italy
facility: Istituti Ospitalieri di Cremona
city: Forlì
country: Italy
facility: Ospedale Morgagni Pierantoni
city: Genova
country: Italy
facility: Ospedale Evangelico
city: Genova
country: Italy
facility: Ospedale Policlinico S. Martino
city: Genova
country: Italy
facility: Ospedale Villa Scassi
city: La Spezia
country: Italy
facility: Ospedale Sant'Andrea
city: Latina
country: Italy
facility: Ospedale S. Maria Goretti
city: Lavagna
country: Italy
facility: Ospedale di Lavagna
city: Legnano
country: Italy
facility: Ospedale di Legnano
city: Magenta
country: Italy
facility: Ospedale di Magenta
city: Milano
country: Italy
facility: Ospedale San Carlo Borromeo
city: Napoli
country: Italy
facility: Ospedale Buon Consiglio Fatebenefratelli
city: Pontedera
country: Italy
facility: Ospedale Felice Lotti
city: Prato
country: Italy
facility: Nuovo Ospedale S. Stefano
city: Rimini
country: Italy
facility: Ospedale Infermi
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratelli
city: San Daniele Del Friuli
country: Italy
facility: Ospedale San'Antonio
city: San Gavino Monreale
country: Italy
facility: Ospedale Nostra Signora di Bonaria
city: San Remo
country: Italy
facility: Ospedale G. Borea
city: Sarzana
country: Italy
facility: Ospedale San Bartolomeo
city: Sassari
country: Italy
facility: Ospedale Civile SS Annunziata
city: Sestri Levante
country: Italy
facility: Ospedale di Sestri Levante
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Torino
country: Italy
facility: Ospedale Cottolengo
city: Treviglio
country: Italy
facility: Ospedale di Treviglio
city: Vercelli
country: Italy
facility: Ospedale Sant'Andrea
city: Voghera
country: Italy
facility: Ospedale Civile di Voghera
Study officials:
affiliation: FADOI Foundation
name: Mauro Campanini
role: STUDY_DIRECTOR
References: