Professional Development in Emergency Medical Services (ProDEms)

Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.

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.

Study Overview

• Status: Withdrawn
• Conditions: Emergency Medical Services; Clinical Practice Guidelines; Clinical Decision Support
• Intervention / Treatment: Procedure: Clinical Decision Support Tool for Prehospital Care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Academic Center for General Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 112 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Study Chair: Bert mr Aertgeerts, PhD, Academic Center for General Practice

Publications and helpful links

Helpful Links

• PhD Project
• Principal Investigator
• Participating Facility
• Affiliated study Department
• Affiliated Study Department

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 21, 2014
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimated): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Emergency Medical Services; Clinical Practice Guidelines
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: ProDEmsTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO