Emergency Medical Services Clinical Trial
— ProDEmsOfficial title:
Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.
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Status | Withdrawn |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 |
Verified date | August 2023 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Academic Center for General Practice | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
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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