Trauma InjuryTRINU-RXNCT05765045
A Nursing Triage Protocol for Minor Orthopedic Traumata: the Effect on Flow Time, Quality of Care and Patient Satisfaction in an Emergency Department
A study testing Nursing triage protocol in people with Trauma Injury, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
In 2019, nearly half of all hospital contacts in Belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. In instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Nursing triage protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Mar 2023to 23 Apr 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18 years old)
- ESI 4 or ESI 5 Recent trauma (< 10 days after trauma)
- Accidental trauma mechanism
- Trauma below the elbow (forearm, wrist, hand, finger)
- Trauma below the knee (lower leg, ankle, foot, toe)
Who cannot join
- ESI 1 or ESI 2 or ESI 3
- Return visit after previous emergency department contact for the same injury (e.g. increased pain, tight cast, ...)
- Trauma resulting from underlying somatic pathology (e.g. syncope, epileptic attack, vertigo, vasovagal collapse, ...)
- Atraumatic (pain) complaints (e.g. pain in the calf, toe, foot, wrist, ... without a clear trauma mechanism)
- Additional, non-orthopedic injuries (e.g. laceration, signs of cerebral commotion, ...)
- Pregnancy or a suspicion of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
In 2019, nearly half of all hospital contacts in Belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. In instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. Previous studies have shown that implementing triage protocols for medical imaging conducted by a triage nurse can reduce the Total Length of Stay (TLOS) for this patient group.
This is a single-center, unblinded, randomized, controlled trial that aims to evaluate the impact of a nurse triage protocol on turnaround time (primary outcome), quality of care, and patient satisfaction. The study population consists of adults who present with minor orthopedic injuries below the elbow or knee and have an Emergency Severity Index (ESI) of 4 or 5. Participants are randomly assigned to either the 'nurse triage protocol' group (n=110) or the 'usual care' group (n=110).
- Conditions
- Trauma Injury
- Being tested
- Nursing triage protocol
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing triage protocolDiagnostic test
Medically approved and supervised standing order that allows trained ER nurses to start medical imaging (RX) for adult patients with minor traumata to the limbs.
| Study group | Role | What they receive |
|---|---|---|
| Nursing triage group | Experimental | Using a triage protocol for medical imaging conducted by a triage nurse in the emergency department Receives: Diagnostic Test: Nursing triage protocol |
| Regular care group | No intervention | Regular triage in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLOS
Total length of stay
Measured: 6-8 weeks
Secondary outcomes (2)
Patient satisfaction
Patient satisfaction measured by a 10-point Likert scale at discharge using a questionnaire
Measured: 6-8 weeks
Treatment efficiency
Measurement if the patient diagnosis and/or treatment was correctly initiated at the Emergency Department. Yes = no additional diagnosis or treatments were necessary; No = within 14 days after discharge a change in treatment or new diagnosis was done. Data will be collected using the hospital's patient records or by calling patients if no information is found in the record.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start6 Mar 2023
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Heilig Hartziekenhuis, Mol
- Responsible party
- Principal investigator, Filip Haegdorens, Universiteit Antwerpen
- Investigators
- Filip Haegdorens, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765045
- Sponsor's protocol ID
- TRINU-RX
- Acronym
- TRINU-RX
- Status last verified
- Jun 2023
- First submitted
- 9 Feb 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nursing Triage Protocol for Minor Orthopedic Traumata: the Effect on Flow Time, Quality of Care and Patient Satisfaction in an Emergency Department
- ClinicalTrials.gov ID
- NCT05765045
- Acronym / sponsor ID
- TRINU-RX / TRINU-RX
- Conditions
- Trauma Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Heilig Hartziekenhuis, Mol
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- 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.
In 2019, nearly half of all hospital contacts in Belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. In instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. Previous studies have shown that implementing triage protocols for medical imaging conducted by a triage nurse can reduce the Total Length of Stay (TLOS) for this patient group.
This is a single-center, unblinded, randomized, controlled trial that aims to evaluate the impact of a nurse triage protocol on turnaround time (primary outcome), quality of care, and patient satisfaction. The study population consists of adults who present with minor orthopedic injuries below the elbow or knee and have an Emergency Severity Index (ESI) of 4 or 5. Participants are randomly assigned to either the 'nurse triage protocol' group (n=110) or the 'usual care' group (n=110).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Nursing triage group | Experimental | Diagnostic Test: Nursing triage protocolUsing a triage protocol for medical imaging conducted by a triage nurse in the emergency department |
| Regular care group | No intervention | –Regular triage in the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18 years old)
- ESI 4 or ESI 5 Recent trauma (< 10 days after trauma)
- Accidental trauma mechanism
- Trauma below the elbow (forearm, wrist, hand, finger)
- Trauma below the knee (lower leg, ankle, foot, toe)
Key exclusion criteria (6 listed)
- ESI 1 or ESI 2 or ESI 3
- Return visit after previous emergency department contact for the same injury (e.g. increased pain, tight cast, ...)
- Trauma resulting from underlying somatic pathology (e.g. syncope, epileptic attack, vertigo, vasovagal collapse, ...)
- Atraumatic (pain) complaints (e.g. pain in the calf, toe, foot, wrist, ... without a clear trauma mechanism)
- Additional, non-orthopedic injuries (e.g. laceration, signs of cerebral commotion, ...)
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 |
|---|---|---|
| Nursing triage protocolMedically approved and supervised standing order that allows trained ER nurses to start medical imaging (RX) for adult patients with minor traumata to the limbs. | Diagnostic test | Nursing triage group |
Primary outcome
TLOS
Time frame: 6-8 weeks
Total length of stay
2 secondary outcomes
Patient satisfaction
Time frame: 6-8 weeks
Treatment efficiency
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- 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.
Filip Haegdorens, PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing triage protocol in people with Trauma Injury, run by Universiteit Antwerpen 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jul 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TLOS (time frame: 6-8 weeks). 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 3 Jul 2023.