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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02365792
Other study ID # ProDEmsTrial
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2025

Study information

Verified date August 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care, taking care on the one hand of patients suffering from time-sensitive critical conditions like STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients whose lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or suffer from acute pain. In the current study the investigators will use a multistage approach to test the hypothesis whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence, 2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without impeding the workflow of the prehospital team or impairing patient safety.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 112 Years
Eligibility Inclusion Criteria: - Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven. Exclusion Criteria: - Patient-related interventions not dispatched by the Emergency Medical Dispatch center (EMD) - Patient related interventions during transport between two healthcare facilities or in mass casualty situations.

Study Design


Intervention

Procedure:
Clinical Decision Support Tool for Prehospital Care
A clinical decision support system (CDSS) is a health information technology system that is designed to assist physicians and other health professionals with clinical decision-making tasks. A working definition of the Centre for Health Evidence: "Clinical Decision Support systems link health observations with health knowledge to influence health choices by clinicians for improved health care".

Locations

Country Name City State
Belgium Academic Center for General Practice Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment protocol adherence Measured by comparing the prescribed actions to be taken following the selected standing order (-s) or procedures, with the actual action (-s) taken. Up to 12 months
Secondary Length of Stay in the ED Measured as the duration between the times the patient is assigned with a unique EAD number in the emergency department and the disposition decision is marked in the Electronic Patient Record (EPR), indicating that the patient is ready to be discharged from the ED. Up to 12 months
Secondary Prehospital Patient Time Interval Measured as the duration between the arrival time at the scene and and arrival time at the ED. Up to 12 months
Secondary Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s) Measured by comparing the selected standing order (-s) or protocol (-s) and the reported diagnose (-s). Up to 12 months
Secondary Alignment between diagnostic accuracy and interventions taken. Measures by comparing the use of available scales and the corresponding prescribed action (-s) to be taken following the standing orders. Up to 12 months
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