NCT02365792

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

8.5 years

First QC Date

June 21, 2014

Last Update Submit

August 29, 2023

Conditions

Keywords

Clinical Decision SupportClinical Practice GuidelinesEmergency Medical Services

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 COMPARATOR

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

CDSS2

ACTIVE COMPARATOR

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

Booklet

PLACEBO COMPARATOR

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

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".

Also known as: CDSS
BookletCDSS1CDSS2

Eligibility Criteria

Age1 Year - 112 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Academic Center for General Practice

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Links

Study Officials

  • Bert mr Aertgeerts, PhD

    Academic Center for General Practice

    STUDY CHAIR
0

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

Locations