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NCT03651414 Clinical Trial

Safety Issues and SurvIval For Medical Outliers

Hospitalization Clinical Trial

— SISIFO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03651414
Other study ID # FADOI.08.2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 19, 2018
Est. completion date September 30, 2020

Study information
Verified date January 2020
Source Fadoi Foundation, Italy
Contact Giovanni Murialdo
Phone 0039 3663213870
Email gmurialdo@unige.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2400
Est. completion date September 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Clinical data collection
There will not be any experimental intervention. The study will be conducted according with normal clinical practice.

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

Sponsors (2)
Lead Sponsor Collaborator
Fadoi Foundation, Italy University of Genova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Mortality rate Mortality rate after 30 days and after 3 months from the hospitalization 3 months
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