NCT06345378

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Nov 2021Dec 2027

Study Start

First participant enrolled

November 25, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

March 28, 2024

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 ASST Papa Giovanni XXIII

    September 2020 - January 2024

  • Algorithm validation

    To validate the classification algorithm on a sample of hospital medical records.

    February 2024 - December 2024

  • 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

  • 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

Study Arms (1)

Elegible population

All adult patients presenting to 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients entering Emergency Department represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

You may qualify if:

  • 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.

You may not qualify if:

  • Voluntary removal of the patient;
  • Sending home with instructions to return for further services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

November 25, 2021

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations