Safety Issues and SurvIval For Medical Outliers (SISIFO)

Fadoi Foundation, Italy

Status: Terminated

Conditions: Hospitalization

Treatments: Other: Clinical data collection

Study type: Observational

Funder types: Other

Identifiers

NCT03651414

FADOI.08.2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,056 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,056 participants in 2 patient groups

Control

Description:

Patients hospitalized ab initio in Internal Medicine or similar for at least one night

Treatment:

Other: Clinical data collection

Outlier

Description:

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

Treatment:

Other: Clinical data collection