Safety Issues and SurvIval For Medical Outliers

Study Overview
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Brief Summary
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Each Investigator will have to record data concerning 70 patients. In particular 40 patients outliers and 30 patients control.

Detailed Description
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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.

Official Title
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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

Conditions
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Hospitalization

Intervention / Treatment
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* Other: Clinical data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Patients hospitalized ab initio in Internal Medicine or similar for at least one night | Other: Clinical data collection<br>* There will not be any experimental intervention. The study will be conducted according with normal clinical practice.<br>|
| Outlier<br>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 | Other: Clinical data collection<br>* There will not be any experimental intervention. The study will be conducted according with normal clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mortality rate | Mortality rate after 30 days and after 3 months from the hospitalization | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outliers