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Professional Development in Emergency Medical Services (ProDEms)

Primary Purpose

Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Clinical Decision Support Tool for Prehospital Care
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Clinical Decision Support focused on measuring Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services

Eligibility Criteria

1 Year - 112 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Academic Center for General Practice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

CDSS1

CDSS2

Booklet

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Prehospital Patient Time Interval
Measured as the duration between the arrival time at the scene and and arrival time at the ED.
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).
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.

Full Information

First Posted
June 21, 2014
Last Updated
August 29, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02365792
Brief Title
Professional Development in Emergency Medical Services
Acronym
ProDEms
Official Title
Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services
Keywords
Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDSS1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CDSS2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Booklet
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Clinical Decision Support Tool for Prehospital Care
Other Intervention Name(s)
CDSS
Intervention Description
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".
Primary Outcome Measure Information:
Title
Treatment protocol adherence
Description
Measured by comparing the prescribed actions to be taken following the selected standing order (-s) or procedures, with the actual action (-s) taken.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Length of Stay in the ED
Description
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.
Time Frame
Up to 12 months
Title
Prehospital Patient Time Interval
Description
Measured as the duration between the arrival time at the scene and and arrival time at the ED.
Time Frame
Up to 12 months
Title
Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s)
Description
Measured by comparing the selected standing order (-s) or protocol (-s) and the reported diagnose (-s).
Time Frame
Up to 12 months
Title
Alignment between diagnostic accuracy and interventions taken.
Description
Measures by comparing the use of available scales and the corresponding prescribed action (-s) to be taken following the standing orders.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
112 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert mr Aertgeerts, PhD
Organizational Affiliation
Academic Center for General Practice
Official's Role
Study Chair
Facility Information:
Facility Name
Academic Center for General Practice
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.kuleuven.be/wieiswie/nl/person/00096106
Description
PhD Project
URL
http://goo.gl/i5mv0R
Description
Principal Investigator
URL
http://goo.gl/sz9yDC
Description
Participating Facility
URL
http://goo.gl/UokRfN
Description
Affiliated study Department
URL
http://goo.gl/zauiok
Description
Affiliated Study Department

Learn more about this trial

Professional Development in Emergency Medical Services

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