ProDEms: Professional Development in Emergency Medical Services

Sponsor
KU Leuven (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02365792
Collaborator
(none)
200
1
3
78
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Clinical Decision Support Tool for Prehospital Care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.
Actual Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CDSS1

The 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.

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".
Other Names:
  • CDSS
  • Active Comparator: CDSS2

    The 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.

    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".
    Other Names:
  • CDSS
  • Placebo Comparator: Booklet

    The 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.

    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".
    Other Names:
  • CDSS
  • Outcome Measures

    Primary Outcome Measures

    1. Treatment protocol adherence [Up to 12 months]

      Measured by comparing the prescribed actions to be taken following the selected standing order (-s) or procedures, with the actual action (-s) taken.

    Secondary Outcome Measures

    1. Length of Stay in the ED [Up to 12 months]

      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.

    2. Prehospital Patient Time Interval [Up to 12 months]

      Measured as the duration between the arrival time at the scene and and arrival time at the ED.

    3. Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s) [Up to 12 months]

      Measured by comparing the selected standing order (-s) or protocol (-s) and the reported diagnose (-s).

    4. Alignment between diagnostic accuracy and interventions taken. [Up to 12 months]

      Measures by comparing the use of available scales and the corresponding prescribed action (-s) to be taken following the standing orders.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 112 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Center for General Practice Leuven Vlaams-Brabant Belgium 3000

    Sponsors and Collaborators

    • KU Leuven

    Investigators

    • Study Chair: Bert mr Aertgeerts, PhD, Academic Center for General Practice

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bert Aertgeerts, Head of the Academic Center for General Practice, KU Leuven
    ClinicalTrials.gov Identifier:
    NCT02365792
    Other Study ID Numbers:
    • ProDEmsTrial
    First Posted:
    Feb 19, 2015
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Bert Aertgeerts, Head of the Academic Center for General Practice, KU Leuven
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2021