NCT03651414

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
• Phase: —
• Study type: Observational
• Enrollment: 2,056 (actual)
• Sponsor: Fadoi Foundation, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hospitalization

Interventions

Type	Name	Description
OTHER	Clinical data collection	There will not be any experimental intervention. The study will be conducted according with normal clinical practice.

Timeline

• Start date: 2018-10-19
• Primary completion: 2020-04-07
• Completion: 2020-07-07
• First posted: 2018-08-29
• Last updated: 2025-02-10

Locations

32 sites across 1 country: Italy