Safety Issues and SurvIval For Medical Outliers

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03651414

Acronym

SISIFO

Enrollment

2056

Registered

2018-08-29

Start date

2018-10-19

Completion date

2020-07-07

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalization

Keywords

Outliers

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.

Interventions

OTHERClinical data collection

There will not be any experimental intervention. The study will be conducted according with normal clinical practice.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026