NCT06372379

Brief Summary

An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
162,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2026

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

April 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

April 9, 2024

Last Update Submit

May 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daschboards

    Develop three different control panels for three different end-users, specifically: 1. Dashboard for citizens 2. Dashboard for healthcare providers 3. Dashboard for healthcare policymakers The aim is to extract the needed information from heterogeneous sources and to feed the dashboards according to the needs of the end-users. On the whole, for citizens, the dashboard will be designed to empower them to choose the most appropriate ED to attend or to consider a different, more relevant or more efficient, health service; for healthcare providers, the dashboard will provide a clear and immediate picture of the ED situation in terms of patient flow and workflow; for healthcare policymakers, the dashboard will provide the ability to monitor specific phenomena of interest, such as ED crowding level, possible incidence of pre-specified epidemiological phenomena, availability and timeliness of primary and secondary patient transfers, ambulance offload delays, etc.

    September 2024 - September 2027

Study Arms (1)

Adults who attended the emergency department

Other: no intervention

Interventions

no intervention

Adults who attended the emergency department

Eligibility Criteria

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

All adult patients who arrived at participating emergency departments between January 1, 2025 and December 31, 2025

You may qualify if:

  • Adult
  • Arrived at emergency department between 1 January 2025 and 31 December 2025

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Guido Bertolini, MD

    Istituto Di Ricerche Farmacologiche Mario Negri

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 18, 2024

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The anonymized data derived from this study could be shared for secondary use in the context of research projects.

Shared Documents
STUDY PROTOCOL