Safety Issues and SurvIval For Medical Outliers

Fadoi Foundation, Italy2,056 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

2,056

Conditions

Hospitalization

Interventions

Clinical data collectionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (32)

Ospedale di Bisceglie - Trani

Bisceglie, Italy

Outcomes

Primary Outcomes

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")

Time frame: 8 months

Secondary Outcomes

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")

Time frame: 8 months

Mortality rate

Mortality rate after 30 days and after 3 months from the hospitalization

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.