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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06345352
Other study ID # IRFMN_7520_PoliMI
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date December 2027

Study information

Verified date March 2024
Source Mario Negri Institute for Pharmacological Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.


Description:

The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1200
Est. completion date December 2027
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients - Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness. Exclusion Criteria: - Voluntary removal of the patient; - Sending home with instructions to return for further services

Study Design


Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milano MI

Sponsors (1)

Lead Sponsor Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Algorithm creation To develop, for the types of patients taken into consideration, a classification algorithm of the appropriateness of admissions based on the files available at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (for simplicity: Policlinico hospital) September 2020 - January 2024
Primary Algorithm validation To validate the classification algorithm on a sample of hospital medical records. February 2024 - December 2024
Primary Algorithm application To apply the validated algorithm on patients referred to the PS of the Policlinico hospital over 36 months, to estimate the proportion of appropriate admissions. January 2025 - December 2027
Primary Appropriateness estimation Provide, for the types of patients considered, an estimate of appropriate discharges for patients discharged and subsequently admitted to the Polyclinic, by drawing on the data available at the polyclinic itself. For all other patients, data on living status and admissions to other facilities in the metropolitan area (PS administrative flow and hospital discharge cards - SDOs), will be analysed using data provided by the ATS Milano Città Metropolitana. January 2025 - December 2027
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