Professional Development in Emergency Medical Services
ProDEms
Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2016
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 21, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 31, 2023
August 1, 2023
8.5 years
June 21, 2014
August 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Length of Stay in the ED
Up to 12 months
Prehospital Patient Time Interval
Up to 12 months
Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s)
Up to 12 months
Alignment between diagnostic accuracy and interventions taken.
Up to 12 months
Study Arms (3)
CDSS1
ACTIVE COMPARATORThe CDSS1 will provide decision support according to existing protocols for clinical procedures and medical treatment, mainly starting from specific symptoms or diagnostic related patients groups. The symptom oriented approach is categorised in a specific list of predetermined conditions.
CDSS2
ACTIVE COMPARATORThe CDSS2 will provide decision support according to existing protocols for clinical procedures and medical treatment, mainly starting from specific symptoms or diagnostic related patients groups. The symptom oriented approach is categorised in a specific list of predetermined conditions.
Booklet
PLACEBO COMPARATORThe control group will provide prehospital patient care with usual decision support: a pocket-size booklet, backed by a mobile phone through which the PIT can get in contact with an Emergency Physician.
Interventions
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".
Eligibility Criteria
You may qualify if:
- Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
Academic Center for General Practice
Leuven, Vlaams-Brabant, 3000, Belgium
Related Links
Study Officials
- STUDY CHAIR
Bert mr Aertgeerts, PhD
Academic Center for General Practice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Academic Center for General Practice
Study Record Dates
First Submitted
June 21, 2014
First Posted
February 19, 2015
Study Start
June 1, 2016
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
August 31, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share