Clinical Decision SupportProDEmsNCT02365792
Professional Development in Emergency Medical Services
A study testing Clinical Decision Support Tool for Prehospital Care in people with Clinical Decision Support and Clinical Practice Guidelines, run by KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 112 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services
- What is being tested?
- Clinical Decision Support Tool for Prehospital Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 112 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Academic Center for General Practice
Leuven, Vlaams-Brabant, 3000
About this study
Official title: 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.
- Being tested
- Clinical Decision Support Tool for Prehospital Care
- Keywords
- Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support Tool for Prehospital CareProcedure or surgery
Also called CDSS
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".
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Clinical Decision Support Tool for Prehospital Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Hoogmartens, KU Leuven
- Investigators
- Bert mr Aertgeerts, PhD, Study chair, Academic Center for General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365792
- Sponsor's protocol ID
- ProDEmsTrial
- Acronym
- ProDEms
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2014
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02365792
- Acronym / sponsor ID
- ProDEms / ProDEmsTrial
- Keywords
- Clinical Decision Support, Clinical Practice Guidelines, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDSS1 | Active comparator | Procedure: Clinical Decision Support Tool for Prehospital CareThe 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 comparator | Procedure: Clinical Decision Support Tool for Prehospital CareThe 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 comparator | Procedure: Clinical Decision Support Tool for Prehospital CareThe 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. |
Who may qualify
- Ages
- 1 year to 112 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support Tool for Prehospital CareAlso: CDSSA 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". | Procedure or surgery | Booklet, CDSS1, CDSS2 |
Primary outcome
Treatment protocol adherence
Time frame: 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.
4 secondary outcomes
Length of Stay in the ED
Time frame: Up to 12 months
Prehospital Patient Time Interval
Time frame: Up to 12 months
Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s)
Time frame: Up to 12 months
Alignment between diagnostic accuracy and interventions taken.
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- PhD ProjectLink provided by the sponsor.
- Principal InvestigatorLink provided by the sponsor.
- Participating FacilityLink provided by the sponsor.
- Affiliated study DepartmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert mr Aertgeerts, PhD study chair
Academic Center for General Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Tool for Prehospital Care in people with Clinical Decision Support and Clinical Practice Guidelines, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment protocol adherence (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.